Dental Implant, Postoperative Pain
Conditions
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
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.
Interventions
DEVICE650 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.
DEVICE810 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.
DEVICESham 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.
Sponsors
National Institute of Laser Enhanced Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants were randomized into three groups: 650 nm PBM, 810 nm PBM, or sham laser therapy. Each group received only one type of intervention.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity Using Numeric Rating Scale (NRS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Intake (Acetaminophen 1000 mg) | 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. |
| Oral Health-Related Quality of Life (OHRQoL) Using OHIP-14 | 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. |
Countries
Egypt
Outcome results
None listed