Clinical trial NCT06988722: Laser Photobiomodulation After Dental Implant Surgery: A Comparison of 650 nm and 810 nm Diode Lasers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: National Institute of Laser Enhanced Sciences
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative Pain Intensity Using Numeric Rating Scale (NRS)
timeFrame: 2, 6, 12, 24, 48, and 72 hours after surgery
Secondary outcomes:
measure: Analgesic Intake (Acetaminophen 1000 mg)
timeFrame: 2, 6, 12, 24, 48, and 72 hours after surgery
measure: Oral Health-Related Quality of Life (OHRQoL) Using OHIP-14
timeFrame: Baseline, 1 week post-implant placement, and 1 week post-prosthesis placement
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: National Institute of Laser Enhanced Sciences (NILES), Cairo University
Study officials:
affiliation: National Institute of Laser Enhanced Sciences (NILES), Cairo University
name: Mohammad M Abdussalam, BDS, MSc
role: PRINCIPAL_INVESTIGATOR
References: