Evaluation of the Analgesic and Anti-Inflammatory Impact of Photobiomodulation in Patients With Dental Implants (AAPDI)

August 1, 2024 updated by: Pia Lopez Jornet, Universidad de Murcia

The aim of this study is to evaluate the analgesic and anti-inflammatory effects of photobiomodulation in participants undergoing dental implant placement.

A randomized clinical trial was conducted with 62 participants requiring dental implant placement, divided into two groups of 31 each. Immediately after implant placement, one group received diode laser photobiomodulation, while the SHAM group received sham treatment. Pain and inflammation were assessed at 24 h, 48 h, and 7 days. In addition, Modified Dental Anxiety (MDA) levels were measured and the Oral Health Impact Profile-14 (OHIP-14) questionnaire was used to assess oral health-related quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low-Level Laser Therapy (LLLT) has revolutionized medicine, promoting the healing and regeneration of tissues in an innovative way. This study focuses on evaluating the powerful analgesic and anti-inflammatory effects of LLLT in patients undergoing dental implant placement.

Methodology A randomized clinical trial was conducted with 62 patients, divided into two groups of 31 each. One group received photobiomodulation with a combined 630 and 808 nm diode laser, while the SHAM group received a simulated treatment.

Inclusion criteria: Participants who needed dental implant rehabilitation and signed the informed consent. Participants with a poor general health status, decompensated chronic diseases (diabetes) , pregnant women, and those with bleeding disorders were excluded.

Procedure:

Informed consent, data collection, complete clinical and oral evaluation, and radiological study with CBCT.

Surgical intervention:

Placement of dental implants. In the experimental group, low-level laser therapy (LLLT) was applied immediately after the placement of the implants in a single session with an EPIC X Biolase diode laser (BIOLASE, Inc., USA), voltage 100-240 V, 1.5 A, power 0.5 W, 10-20 J, for 10-30 seconds. It was applied to three points in the area: buccal side, palatal/lingual side, and occlusal side to stimulate the tissue.

Pain and inflammation were evaluated using visual analog scales (VAS) from day 0 to 7 days postoperatively. Additionally, MDA levels were measured and the OHIP-14 questionnaire was used to assess oral health-related quality of life

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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 Locations

  • Spain
      • Murcia, Spain, 30008
        • Pia Lopez Jornet

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants who needed dental implant rehabilitation and signed the informed consent

Exclusion Criteria:

  • Participants with a poor general health status, decompensated chronic diseases, pregnant women, and those with bleeding disorders were excluded.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group1 laser therapy
Data collection, informed consent, a complete clinical and oral evaluation, as well as a radiological study with cone beam computed tomography (CBCT). A surgical intervention was performed with the placement of dental implants. In the experimental group, low-level laser therapy (LLLT) was applied immediately after the placement of the implants in a single session with an EPIC X Biolase diode laser (BIOLASE, Inc., USA), voltage 100-240 V, 1.5 A, power 0.5 W, 10-20 J, for 10-30 seconds. It was applied to three points in the area: buccal side, palatal/lingual side, and occlusal side to stimulate the tissue.Pain and inflammation were evaluated using visual analog scales (VAS) from day 0 to 7 days postoperatively. Additionally, MDA levels were measured and the OHIP-14 questionnaire was used to assess oral health-related quality of life
Device: laser therapy After implant surgery, laser therapy (LLLT) was applied
After implant surgery, laser therapy (LLLT) was applied a single session with an EPIC X Biolase diode laser (BIOLASE, Inc., USA)
Other Names:
  • Experimental
Sham Comparator: group Sham
data collection, informed consent, a complete clinical and oral evaluation, as well as a radiological study with cone beam computed tomography (CBCT). Surgical intervention was performed with the placement of dental implants. In the group sham comparate p, low-level laser therapy (LLLT) was applied inactive . Pain and inflammation were evaluated using visual analog scales (VAS) from day 0 to 7 days postoperatively. Additionally, MDA levels were measured and the OHIP-14 questionnaire was used to assess oral health-related quality of life
Device: SHAM
After implant surgery, After implant surgery, laser therapy (LLLT) was applied in the same manner but without activating it
Other Names:
  • After implant surgery, laser therapy (LLLT) was applied without activating it

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain levels assessed with the visual analogue scale (VAS)
Time Frame: 24h-48h,7 days
A score of 0 indicated no pain while 10 indicated the worst pain possible
24h-48h,7 days
inflammation evels assessed with the visual analogue scale
Time Frame: 24h-48h,7 days
A score of 0 indicated no inflammation while 10 indicated the worst inflammation possible
24h-48h,7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Corah Dental Anxiety Scale (MDAS)
Time Frame: at day 0 and 7 days
(0 relaxed, 1 slightly anxious, 2 quite anxious, 3 very anxious or 4 extremely anxious). The total sum was obtained and 4 ranges of fear and anxiety were established (<9 mild or no anxiety, 9-12 moderate anxiety, 13-14 high anxiety, >14 phobic anxiety, >14 very anxious anxiety, >14 very anxious anxiety, >14 very anxious anxiety, >14 very anxious anxiety, >14 very anxious anxiety).
at day 0 and 7 days
OHIP-14sp
Time Frame: at 0 and at 7 days
consists of 14 questions related to different dimensions of the patient's quality of life (functional limitation, pain, psychological problems, etc.) higher score worse quality of life
at 0 and at 7 days

Collaborators and Investigators

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

Sponsor

Universidad de Murcia

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)

January 10, 2022

Primary Completion (Actual)

January 10, 2024

Study Completion (Actual)

June 10, 2024

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2934/2020

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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