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| ID | Type | Description | Link |
|---|---|---|---|
| NILES-EC-CU 23/7/18(In) | Other Identifier | NILES, Cairo University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 650 nm PBM | Experimental | 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. |
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| 810 nm PBM | Experimental | 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. |
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| Sham PBM | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2, 6, 12, 24, 48, and 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad M Abdussalam, BDS, MSc | National Institute of Laser Enhanced Sciences (NILES), Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Laser Enhanced Sciences (NILES), Cairo University | Giza | Giza Governorate | 12613 | Egypt |
Individual participant data (IPD) that underlie the results reported in this article will be made available after de-identification, upon reasonable request and following institutional and ethical approvals. Supporting documents such as study protocol and statistical analysis plan may also be shared as needed.
Data will be shared beginning 6 months following publication and will be available for up to 3 years upon reasonable request.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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Participants were randomized into three groups: 650 nm PBM, 810 nm PBM, or sham laser therapy. Each group received only one type of intervention.
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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.
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| 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. |
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| 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. |
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| 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. | Baseline, 1 week post-implant placement, and 1 week post-prosthesis placement |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |