Postoperative PainNCT06988722
Laser Photobiomodulation After Dental Implant Surgery: A Comparison of 650 nm and 810 nm Diode Lasers
A study testing 650 nm Diode Laser PBM and 810 nm Diode Laser PBM in people with Postoperative Pain and Dental Implant, run by National Institute of Laser Enhanced Sciences at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Postoperative Pain, Dental Implant
- What is being tested?
- 650 nm Diode Laser PBM and 810 nm Diode Laser PBM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Aug 2023to 29 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
National Institute of Laser Enhanced Sciences (NILES), Cairo University
Giza, Giza Governorate, 12613
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Pain, Dental Implant
- Being tested
- 650 nm Diode Laser PBM, 810 nm Diode Laser PBM, Sham Laser PBM
- 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
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
650 nm Diode Laser PBMDevice
Also called Red laser therapy, Low-Level Laser Therapy (650 nm)
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.
810 nm Diode Laser PBMDevice
Also called Infrared laser therapy, Low-Level Laser Therapy (810 nm), Near-Infrared laser therapy
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.
Sham Laser PBMDevice
Also called Sham Photobiomodulation, Inactive Laser
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 650 nm Diode Laser PBM |
| 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. Receives: Device: 810 nm Diode Laser PBM |
| 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. Receives: Device: Sham Laser PBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2, 6, 12, 24, 48, and 72 hours after surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 1 week post-implant placement, and 1 week post-prosthesis placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start17 Aug 2023
- Primary completion2 Jun 2024
- Study completion29 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Laser Enhanced Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mohammad Mahmoud Yehya Abdussalam, National Institute of Laser Enhanced Sciences
- Investigators
- Mohammad M Abdussalam, BDS, MSc, Principal investigator, National Institute of Laser Enhanced Sciences (NILES), Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988722
- Sponsor's protocol ID
- ZZA-PBM-2024-RCT01
- Other IDs
- NILES-EC-CU 23/7/18(In)
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06988722
- Acronym / sponsor ID
- ZZA-PBM-2024-RCT01
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Laser Enhanced SciencesUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 650 nm PBM | Experimental | Device: 650 nm Diode Laser PBMParticipants 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. |
| 810 nm PBM | Experimental | Device: 810 nm Diode Laser PBMParticipants 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. |
| Sham PBM | Sham comparator | Device: Sham Laser PBMParticipants 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 650 nm Diode Laser PBMAlso: Red laser therapy, Low-Level Laser Therapy (650 nm)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. | Device | 650 nm PBM |
| 810 nm Diode Laser PBMAlso: Infrared laser therapy, Low-Level Laser Therapy (810 nm), Near-Infrared laser therapyA 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. | Device | 810 nm PBM |
| Sham Laser PBMAlso: Sham Photobiomodulation, Inactive LaserIdentical 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. | Device | Sham PBM |
Primary outcome
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.
2 secondary outcomes
Analgesic Intake (Acetaminophen 1000 mg)
Time frame: 2, 6, 12, 24, 48, and 72 hours after surgery
Oral Health-Related Quality of Life (OHRQoL) Using OHIP-14
Time frame: Baseline, 1 week post-implant placement, and 1 week post-prosthesis placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad M Abdussalam, BDS, MSc principal investigator
National Institute of Laser Enhanced Sciences (NILES), Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 650 nm Diode Laser PBM and 810 nm Diode Laser PBM in people with Postoperative Pain and Dental Implant, run by National Institute of Laser Enhanced Sciences at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Using Numeric Rating Scale (NRS) (time frame: 2, 6, 12, 24, 48, and 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.