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

NCT ID: NCT06988722

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2024-06-29

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.

Detailed Description

This randomized, double-blind, sham-controlled clinical trial assessed the short-term effects of photobiomodulation (PBM) using 650 nm and 810 nm diode lasers on postoperative pain, analgesic intake, and oral health-related quality of life (OHRQoL) following single dental implant placement in the posterior maxilla.

Methods:

Sixty participants were randomized into three equal groups (650 nm PBM, 810 nm PBM, or sham). All underwent a standardized H-design flap surgery and implant placement. PBM was applied at three points around the implant (buccal, palatal, crestal) using 100 mW power for 60 seconds per point (total 18 J), repeated within 48 hours.

Outcomes:

Primary outcome: Pain intensity measured using an 11-point Numeric Rating Scale (NRS) at 2, 6, 12, 24, 48, and 72 hours after surgery.

Secondary outcomes: Number of analgesics used (acetaminophen 1000 mg as needed), and changes in OHRQoL as measured by the OHIP-14 questionnaire at baseline, 1 week after implant placement, and 1 week after crown delivery.

Conditions

Postoperative Pain; Dental Implant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

650 nm PBM

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.

Group Type: EXPERIMENTAL

650 nm Diode Laser PBM

Intervention Type: 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.

810 nm PBM

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.

Group Type: EXPERIMENTAL

810 nm Diode Laser PBM

Intervention Type: 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.

Sham PBM

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.

Group Type: SHAM_COMPARATOR

Sham Laser PBM

Intervention Type: 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.

Interventions

650 nm Diode Laser PBM

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.

Intervention Type: DEVICE

810 nm Diode Laser PBM

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.

Intervention Type: DEVICE

Sham Laser PBM

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.

Intervention Type: DEVICE

Other Intervention Names

Red laser therapy; Low-Level Laser Therapy (650 nm); Infrared laser therapy; Low-Level Laser Therapy (810 nm); Near-Infrared laser therapy; Sham Photobiomodulation; Inactive Laser

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Laser Enhanced Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Mohammad Mahmoud Yehya Abdussalam

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad M Abdussalam, BDS, MSc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Giza, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

NILES-EC-CU 23/7/18(In)

Identifier Type: OTHER

Identifier Source: secondary_id

ZZA-PBM-2024-RCT01

Identifier Type: -

Identifier Source: org_study_id