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NCT Number: NCT06988722

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

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.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Giza, Giza Governorate, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Red laser therapy, Low-Level Laser Therapy (650 nm)

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.

Other names: Infrared laser therapy, Low-Level Laser Therapy (810 nm), Near-Infrared laser therapy

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.

Other names: Sham Photobiomodulation, Inactive Laser

Primary outcomes

  1. Postoperative Pain Intensity Using Numeric Rating Scale (NRS)

    Time frame: 2, 6, 12, 24, 48, and 72 hours after surgery

    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.

Secondary outcomes

  1. Analgesic Intake (Acetaminophen 1000 mg)

    Time frame: 2, 6, 12, 24, 48, and 72 hours after surgery

    Analgesic use was self-recorded at 2, 6, 12, 24, 48, and 72 hours postoperatively. At each interval, participants documented whether they had taken a 1000 mg dose of acetaminophen within the prior 4 hours (Yes/No). This binary outcome was used to correlate pain scores with analgesic consumption and to assess the frequency of rescue medication use across study groups. Participants were instructed to take acetaminophen only if their pain exceeded an NRS score of 3.

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

    Time frame: Baseline, 1 week post-implant placement, and 1 week post-prosthesis placement

    OHRQoL was measured using the validated Oral Health Impact Profile-14 (OHIP-14) questionnaire. Participants completed the OHIP-14 electronically at three time points: baseline (before surgery), 1 week after implant placement, and 1 week after prosthesis placement. The impact of treatment on oral health-related quality of life was evaluated by comparing OHIP-14 scores within and between groups over time.

Sponsors and collaborators

Lead sponsor

National Institute of Laser Enhanced Sciences

Other

Registry information

Official study title

Comparative Effects of 650 nm and 810 nm Diode Laser Photobiomodulation on Postoperative Pain, Analgesic Use, and OHRQoL After Dental Implant Surgery: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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