Laser Photobiomodulation After Dental Implant Surgery: A Comparison of 650 nm and 810 nm Diode Lasers

NCT06988722 | Completed

• 2 other identifiers: ZZA-PBM-2024-RCT01NILES-EC-CU 23/7/18(In)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of laser light therapy, known as photobiomodulation (PBM), in reducing pain after dental implant surgery. The study involves adult patients receiving a single dental implant in the upper posterior (back) area of the mouth. Participants are randomly assigned to receive PBM using either a 650 nm red diode laser, an 810 nm infrared diode laser, or a sham (inactive) laser. The study aims to assess whether PBM therapy can reduce pain during the first three days after surgery, decrease the need for pain medication, and improve oral health-related quality of life (OHRQoL). PBM is applied immediately after surgery and again within 48 hours. Pain intensity is measured at multiple time points (2, 6, 12, 24, 48, and 72 hours), analgesic use is recorded, and OHRQoL is evaluated using a standardized questionnaire.

Conditions

Postoperative Pain; Dental Implant

Keywords

Photobiomodulation; Low-Level Laser Therapy; Diode Laser; 650 nm Laser; 810 nm Laser; Dental Implant Surgery; Pain Management; OHIP-14; OHRQoL; Numerical Rating Scale

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity Using Numeric Rating Scale (NRS)

  Postoperative pain intensity was assessed using an 11-point Numeric Rating Scale (NRS: 0-10) at 2, 6, 12, 24, 48, and 72 hours after surgery. Participants recorded the maximum pain experienced since the previous interval. Pain was analyzed in two ways: (1) Temporal analysis of mean NRS scores across Day 1 (defined as the highest score within 24 hours), Day 2, and Day 3 to assess daily pain evolution; and analysis of specific time points on Day 1 (2, 6, 12, 24 hours) to explore early postoperative pain dynamics. (2) Categorical analysis of NRS scores classified into five pain severity levels: no, mild, moderate, severe, and unbearable pain. Group comparisons were conducted using ANOVA or Kruskal-Wallis tests for continuous data and Chi-square tests for categorical distributions.

  2, 6, 12, 24, 48, and 72 hours after surgery

Secondary Outcomes (2)

• Analgesic Intake (Acetaminophen 1000 mg)

  2, 6, 12, 24, 48, and 72 hours after surgery

• Oral Health-Related Quality of Life (OHRQoL) Using OHIP-14

  Baseline, 1 week post-implant placement, and 1 week post-prosthesis placement

Study Arms (3)

650 nm PBM

EXPERIMENTAL

Participants in this arm received photobiomodulation therapy using a 650 nm red diode laser. The laser was applied at three points (buccal, palatal, and crestal) around the implant site at 100 mW for 60 seconds per point, delivering a total dose of 18 J. PBM was applied immediately after implant placement and repeated within 48 hours.

Device: 650 nm Diode Laser PBM

810 nm PBM

EXPERIMENTAL

Participants in this arm received photobiomodulation therapy using an 810 nm infrared diode laser. The laser was applied at three points (buccal, palatal, and crestal) around the implant site at 100 mW for 60 seconds per point, delivering a total dose of 18 J. PBM was applied immediately after implant placement and repeated within 48 hours.

Device: 810 nm Diode Laser PBM

Sham PBM

SHAM COMPARATOR

Participants in this arm received sham photobiomodulation therapy. The same laser handpiece was applied at the same points and durations as the active groups, but with the laser emission disabled. The procedure was designed to appear identical to active PBM treatment to maintain blinding. The sham was applied immediately after implant placement and repeated within 48 hours.

Device: Sham Laser PBM

Interventions

650 nm Diode Laser PBM DEVICE

A 650 nm red diode laser applied at three points (buccal, palatal, and crestal) around the implant site using 100 mW power for 60 seconds per point (total dose 18 J). Applied immediately post-op and repeated within 48 hours. Used for photobiomodulation to reduce pain and improve healing.

Also known as: Red laser therapy, Low-Level Laser Therapy (650 nm)

650 nm PBM

810 nm Diode Laser PBM DEVICE

A 810 nm red diode laser applied at three points (buccal, palatal, and crestal) around the implant site using 100 mW power for 60 seconds per point (total dose 18 J). Applied immediately post-op and repeated within 48 hours. Used for photobiomodulation to reduce pain and improve healing.

Also known as: Infrared laser therapy, Low-Level Laser Therapy (810 nm), Near-Infrared laser therapy

810 nm PBM

Sham Laser PBM DEVICE

Identical laser handpiece applied at the same locations and durations as the active PBM groups, but without laser emission. Used to maintain blinding and simulate treatment without therapeutic effect.

Also known as: Sham Photobiomodulation, Inactive Laser

Sham PBM

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20-65 years.
• Indicated for single dental implant placement in the posterior maxilla.
• ASA physical status I or II.
• Good oral health.
• Willingness and ability to comply with study procedures and follow-up schedule.
• Able to provide written informed consent.

You may not qualify if:

• Use of analgesics, NSAIDs, or corticosteroids within 48 hours prior to surgery.
• History of alcohol abuse or regular consumption of \>14 drinks/week (men) or \>7 drinks/week (women), or withdrawal within the last 6 months.
• History of chronic pain or long-term pain medication use.
• Need for grafting, sinus lift, or complex implant procedures.
• Pregnant or breastfeeding.
• Uncontrolled systemic disease (e.g., uncontrolled diabetes, immunodeficiency).
• History of epilepsy, photosensitivity, or contraindications to laser therapy.
• Allergy or contraindication to acetaminophen.
• Previous implant or surgical treatment in the same site within the past 6 months.
• Heavy smokers (\>12 cigarettes/day) or individuals who quit smoking within the past 6 months.

Sponsors & Collaborators

• National Institute of Laser Enhanced Sciences: lead

Study Sites (1)

National Institute of Laser Enhanced Sciences (NILES), Cairo University

Giza, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Mohammad M Abdussalam, BDS, MSc

  National Institute of Laser Enhanced Sciences (NILES), Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors were blinded to group allocation. The operator administering the laser therapy was not blinded due to the nature of the device used. Sham PBM was visually identical to active laser settings to maintain blinding for all other parties.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomized into three groups: 650 nm PBM, 810 nm PBM, or sham laser therapy. Each group received only one type of intervention.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 25, 2025
• Study Start: August 17, 2023
• Primary Completion: June 2, 2024
• Study Completion: June 29, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be shared beginning 6 months following publication and will be available for up to 3 years upon reasonable request.
• Access Criteria: * Data will be made available to qualified researchers for individual participant meta-analysis or academic research focused on dental implant outcomes and photobiomodulation. Requests should be submitted with a brief research proposal and data use agreement. Approved data will be shared electronically via email or a secure cloud-based system. * Mechanism of access: Requests should be sent to std.zein.adham@niles.edu.eg

Locations

EG (1)