Clinical Efficacy of Frenectomies Using Diode Laser Versus Conventional Techniques

May 15, 2017 updated by: Berceste Guler, T.C. Dumlupınar Üniversitesi

Patient Perceptions and Clinical Efficacy of Frenectomies Using Diode Laser Versus Conventional Techniques

The aim of present study was to compare the keratinized gingival tissue measurements, degree of subjective complaints, and functional complications of using an 980 nm diode laser versus a scalpel for frenectomies. Thirty-six patients requiring frenectomies, between 18 and 51 years old, were randomly assigned to either scalpel or diode laser treatments. The soft tissue measurements, including the keratinized gingiva width (KGW), attached gingiva width(AGW), and attached gingiva thickness (AGT), were recorded before surgery, immediately after, one week later, and one, three, and six months after surgery. In addition, the functional complications and the morbidity (level of pain, swelling, and redness) were evaluated during the first postoperative week using a visual analog scale (VAS). The VAS scores indicated that the patients treated with a diode laser had less discomfort and functional complications compare with scalpel surgery.

Study Overview

Status

Status

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

Conditions

Conditions

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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

The whole mouth records of each participant served as a basis for the clinical periodontal diagnoses. Prior to the frenectomy, the same investigator recorded the following parameters: plaque index (PLI), gingival index (GI), pocket probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP). All of the clinical parameters were measured at six sites per tooth (mesio, mid, and distobuccal, and mesio, mid, and distopalatal) using a Williams periodontal probe (Nordent Manufacturing Inc., Elk Grove Village, IL, USA) calibrated in millimeters.

The patients were instructed to record the postoperative degrees of pain, redness, swelling, and functional complications, including chewing and speech, on a 10 cm horizontal visual analog scale (VAS), by placing a vertical mark between the two endpoints, from the first through seventh days. The scale was graded from left to right with values ranging from "0" (no pain, functional complications, discomfort, swelling, or redness) to "10" (worst pain, extreme functional complications, extreme discomfort, extreme swelling, and extreme redness). The keratinized gingiva width (KGW), attached gingiva width (AGW), and attached gingiva thickness (AGT) were also recorded before the surgery. Postoperative analyses were performed at four separate times: immediately, at the first week, and at the first and third months after surgery. The patients in each group were also asked if they required anesthesia during the operation and analgesics after the operation.

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.
28

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

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

14 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Those subjects with maxillary anterior frenula extending to the interdental papilla of the central incisors, those undergoing frenectomies for orthodontic, prosthodontic, or periodontal treatment and those with no surgical contraindications were included in this study.

Exclusion Criteria:

  • The patients were excluded if they exhibited poor oral hygiene, received periodontal therapy, were being treated with antibiotics, anti-inflammatories, or analgesics during the previous three months, or if they had any systemic conditions that could affect oral surgery.

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: None (Open Label)

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: Diode laser
A 2.8 W, 980 nm diode laser(Sirona Advanced) in continuous wave mode with an air cooling handpiece was used in the alternative frenectomy technique. The frenulum was held with a hemostat, and a repeated continuous wave mode was applied for the excision. It was also used to remove the periosteal adhesion. The remnants of the ablated tissue were removed with saline, and no sutures were placed after the diode laser treatment.
Procedure: Diode laser
2.8 W diode laser surgery were applied on high frenulum attachment and follow-up VAS scores were evaluated
Other Names:
  • Sirona Advanced
Active Comparator: Scalpel
(1) topical anesthesia (20% benzocaine), (2) local anesthesia using the bilateral vestibular infiltration technique, with 0.6 ml (1/3 of the carpule contents) of 4% articaine and 1:200,000 epinephrine, (3) hemostatic clamping of the frenulum, (4) excision of the whole band of tissue, together with its alveolar attachment, with a 15C scalpel blade, (5) relaxation and unbending of any fibrous adhesions to the underlying periosteum, and (6) simple suturing with 5-0 silk thread
Procedure: Scalpel
Scalpel surgery were performed after local anesthetic administration and VAS scores were recorded.

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
postoperative degrees of pain
Time Frame: Change from postoperative first week at postoperative third month
visual analog scale (0 to 10 cm)
Change from postoperative first week at postoperative third month

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
plague index
Time Frame: preoperative
between 0 to 4 scale
preoperative
functional complications
Time Frame: Change from postoperative first week at postoperative third month
visual analog scale (0 to 10 cm)
Change from postoperative first week at postoperative third month

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.
T.C. Dumlupınar Üniversitesi

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.
  • Study Director: Ahu Uraz, PhD Dr, Gazi University Faculty of Dentistry

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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.
February 1, 2015

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.
June 30, 2015

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.
May 10, 2017

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 15, 2017

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 15, 2017

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.
May 17, 2017

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.
May 17, 2017

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.
May 15, 2017

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.
May 1, 2017

More Information

Terms related to this study

Keywords

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.
  • 2015-KAEK-86/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The patients will be instructed to record the postoperative degrees of pain, redness, swelling, and functional complications, including chewing and speech, on a 10 cm horizontal visual analog scale (VAS), by placing a vertical mark between the two endpoints, from the first through seventh days.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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