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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
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.
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.
National Institute of Laser Enhanced Sciences (NILES), Cairo University
Giza, Giza Governorate, Egypt
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.
Time frame: 2, 6, 12, 24, 48, and 72 hours after surgery
Analgesic Intake (Acetaminophen 1000 mg)
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.
Time frame: 2, 6, 12, 24, 48, and 72 hours after surgery
Oral Health-Related Quality of Life (OHRQoL) Using OHIP-14
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.
Time frame: Baseline, 1 week post-implant placement, and 1 week post-prosthesis placement
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.