LLLT Effects on Inferior Alveolar Nerve (IAN) Recovery Post-orthognathic Surgery

June 20, 2025 updated by: Albert Einstein College of Medicine
Low-level laser therapy (LLLT) is a well-studied technique that has been shown to improve recovery time and reduce pain and swelling in patients undergoing surgery, including orthognathic surgery, and has no known negative effects. This study will use two groups with patients randomly assigned to either the study group, receiving LLLT, or one receiving a placebo treatment, after they have lower jaw surgery. Measurements will be taken at 24 hours, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 week post-op exams to check pain, swelling and nerve function, and the two groups will be compared to see if the LLLT group has any difference

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Low-level laser therapy (LLLT) is a well-studied technique to induce biomodulation of pain and wound healing. The technique has been shown to improve recovery time and reduce pain and swelling in patients undergoing surgery, including orthognathic surgery, and has no known negative effects. Previous studies have used split-mouth designs, short follow-up periods or, often, both. This study aims to have two groups, one receiving LLLT and one receiving a dummy treatment, at 24 hours, 1 week, 2 week, 3 week, 4 week, 5 week, and 6 week post-op exams. At each visit, pain (via VAS), swelling (measured from the midpoint of the chin to the base of the ear, bilaterally), and nerve function (using a soft and hard sensory test, in 8 regions of the mandible and lower lip) will be performed, with additional measurements at 8 weeks and 20 weeks. The measurements will be analyzed for statistical differences between the LLLT intervention group and non-intervention group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center, Department of Dentistry and Oral Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients undergoing mandibular surgery with bilateral sagittal split osteotomies

Exclusion Criteria:

  • patients must be free from pre-operative inferior alveolar neurosensory deficiencies
  • intra-operative accidental fracture or rupture of the inferior alveolar nerve

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-level therapy intervention
Patients will receive low-level laser therapy on the skin overlying the mandible for 40 seconds per side. All other post-operative care will be as per clinic routine.
Device: Low-level laser therapy
The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
Placebo Comparator: dummy intervention
Patients will receive no dose of laser, but the handpiece will be used against their skin top mimic the LLLT. All other post-operative care will be as per clinic routine.
Device: Dummy LLLT
The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Inferior Alveolar Nerve Function for Soft Stimuli
Time Frame: 24 hours post-surgery
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
24 hours post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli
Time Frame: 1 week post-surgery
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
1 week post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli
Time Frame: 2 weeks post-surgery
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
2 weeks post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli
Time Frame: 3 weeks post-surgery
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
3 weeks post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli
Time Frame: 4 weeks post-surgery
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
4 weeks post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli
Time Frame: 5 weeks post-surgery
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
5 weeks post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli
Time Frame: 6 weeks post-surgery
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
6 weeks post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli
Time Frame: 8 weeks post-surgery
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
8 weeks post-surgery
Inferior Alveolar Nerve Function for Soft Stimuli
Time Frame: 20 weeks post-surgery
IAN function for soft stimuli was assessed by brushing a cotton swab along a 2cm path of the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2 and 3 are on the skin of lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were identified as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the cotton swab using a binary Yes (+) or No (-) response. The number of patients who responded Yes is summarized by study arm.
20 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli
Time Frame: 24 hours post-surgery
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
24 hours post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli
Time Frame: 1 week post-surgery
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
1 week post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli
Time Frame: 2 weeks post-surgery
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
2 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli
Time Frame: 3 weeks post-surgery
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
3 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli
Time Frame: 4 weeks post-surgery
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
4 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli
Time Frame: 5 weeks post-surgery
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
5 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli
Time Frame: 6 weeks post-surgery
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
6 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli
Time Frame: 8 weeks post-surgery
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
8 weeks post-surgery
Inferior Alveolar Nerve Function for Hard Stimuli
Time Frame: 20 weeks post-surgery
IAN function for hard stimuli was assessed by pressing a toothpick into the skin of the mandible and lower lip in 8 regions along the lower jaw. Regions right and left 1, 2, and 3 are on the skin of the lower face, 1 cm apart, starting on the midline, and right and left region 4 is the lower lip, separated at the midline. Right and left regions were abbreviated as R1, R2, R3, R4 and L1, L2, L3, and L4, respectively. Patients responded as to whether they were able to feel the toothpick using a binary Yes (+) or No (-) response. The number of patients who responded Yes (+) is summarized by study arm.
20 weeks post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-operative Pain
Time Frame: 24 hours post-surgery
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
24 hours post-surgery
Post-operative Pain
Time Frame: 1 week post-surgery
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
1 week post-surgery
Post-operative Pain
Time Frame: 2 weeks post-surgery
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
2 weeks post-surgery
Post-operative Pain
Time Frame: 3 weeks post-surgery
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
3 weeks post-surgery
Post-operative Pain
Time Frame: 4 weeks post-surgery
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
4 weeks post-surgery
Post-operative Pain
Time Frame: 5 weeks post-surgery
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
5 weeks post-surgery
Post-operative Pain
Time Frame: 6 weeks post-surgery
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
6 weeks post-surgery
Post-operative Pain
Time Frame: 8 weeks post-surgery
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
8 weeks post-surgery
Post-operative Pain
Time Frame: 20 weeks post-surgery
Post-operative pain was assessed and reported during each study visit using a single-item Visual Analog Scale (VAS) question. Patients rated the intensity of pain on each side of the mandible (right and left) on an 11-point Likert scale. Possible VAS scores ranged from 0 (complete absence of pain) to 10 (maximum amount of pain imaginable). Results were summarized by study arm using basic descriptive statistics.
20 weeks post-surgery
Post-operative Mandibular Swelling
Time Frame: 24 hours post-surgery
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
24 hours post-surgery
Post-operative Mandibular Swelling
Time Frame: 1 week post-surgery
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
1 week post-surgery
Post-operative Mandibular Swelling
Time Frame: 2 weeks post-surgery
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
2 weeks post-surgery
Post-operative Mandibular Swelling
Time Frame: 3 weeks post-surgery
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
3 weeks post-surgery
Post-operative Mandibular Swelling
Time Frame: 4 weeks post-surgery
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
4 weeks post-surgery
Post-operative Mandibular Swelling
Time Frame: 5 weeks post-surgery
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
5 weeks post-surgery
Post-operative Mandibular Swelling
Time Frame: 6 weeks post-surgery
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
6 weeks post-surgery
Post-operative Mandibular Swelling
Time Frame: 8 weeks post-surgery
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
8 weeks post-surgery
Post-operative Mandibular Swelling
Time Frame: 20 weeks post-surgery
Post-operative mandibular swelling was measured using soft measuring tape. The extent of post-operative swelling was measured from the tip of the chin to the base of the earlobe bilaterally (right and left). Measurements were recorded in millimeters (mm) and results summarized by study arm using basic descriptive statistics.
20 weeks post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Albert Einstein College of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timothy Levine, DMD, Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-12990

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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