Peri-Implantitis and Peri-implant MucositisNCT07287956
The Use of Adjunct Oxygen High-Level Laser Therapy on the Clinical and Microbiological Outcomes of Peri-implant Disease
A study testing Oxygen high-level laser therapy (Diode laser and hydrogen peroxide) and Diode laser therapy in people with Peri-Implantitis and Peri-implant Mucositis, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
The goal of this clinical trial is to learn whether using a special light-activated treatment called photodynamic therapy, or more specifically, its modified version called oxygen high-level laser therapy, using a high-powered diode laser along with 3% hydrogen peroxide, can improve gum health around dental implants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis and Peri-implant Mucositis
- What is being tested?
- Oxygen high-level laser therapy (Diode laser and hydrogen peroxide) and Diode laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteJordan
- Study dates
- 5 Feb 2024to 1 Aug 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years or older.
- Patients diagnosed with peri-implant disease (peri-implant mucositis or peri-implantitis) according to the 2017 World Workshop criteria in at least two non-adjacent, single-crown, bone-level dental implants.
- Patients that have not undergone periodontal treatment and/or were prescribed antibiotics in the last three months prior to initial visit.
- Patients with a healthy periodontal status
- At least 1 year of functional implants.
- Non-Smokers.
Who cannot join
- Immunocompromised patients.
- Pregnancy or breastfeeding.
- Known allergies to any materials used in the study.
- Patients classified as ASA Physical Status ≥ III.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn whether using a special light-activated treatment called photodynamic therapy, or more specifically, its modified version called oxygen high-level laser therapy, using a high-powered diode laser along with 3% hydrogen peroxide, can improve gum health around dental implants. It tests whether adding this to regular cleaning treatments could reduce harmful bacteria and support better healing. The aim is to determine whether a specific protocol is an effective way to treat infections around dental implants.
Participants in the study will receive two types of treatment on different dental implants:
Read more
- One implant will be treated with the oxygen high-level laser therapy using diode laser and hydrogen peroxide after mechanical cleaning.
- The other implant will receive diode laser therapy without hydrogen peroxide after mechanical cleaning.
Researchers will compare how the gums respond to each treatment, looking at signs such as inflammation, and determine whether the number of harmful bacteria has been reduced at three time points.
Read the detailed description
Participants attending with at least two non-adjacent dental implants diagnosed with peri-implant disease (peri-implant mucositis and peri-implantitis) will be enrolled in the study. All patients included will be examined, and periodontal chartings will be obtained using a PCPUNC 15 probe. After routine phase one therapy (mechanical debridement using carbon-coated curettes on dental implants and ultrasonic scaling on the rest of the dentition), implant pocket irrigation using normal saline will be performed in both groups. Following irrigation using normal saline, implant pockets will be irrigated with 3% hydrogen peroxide, left in place for 2 minutes, and then irradiated with a 940nm diode laser (2.5W power, high frequency, 10 KHz, power average 0.5 W, fluency 25,000 J/cm2, 416.66 J/cm2 per second [Rey Protocol]) for 60 s per site in the test group. Control groups will receive mechanical debridement and diode laser treatment alone without the use of hydrogen peroxide.
Baseline clinical parameters will be measured at the initial visit and compared to post-treatment results at 6 weeks and 3 months. The clinical parameters to be evaluated include probing pocket depth, gingival index, plaque index, bleeding on probing, and suppuration.
In addition, microbiological parameters (bacterial count) using quantitative real-time polymerase chain reaction (qPCR) analysis will be determined from subgingival plaque samples using sterile paper points before and after treatment of both groups left in place for 30 seconds. Supragingival plaque is to be removed, and microbiological samples are to be taken before any measurements and/or non-surgical periodontal therapy (NSPT) from the deepest peri-implant pockets (sites are to be isolated with cotton rolls and gently air dried to avoid contamination with saliva). Immediately following treatment, a second swab will be taken from the implant surface using the same procedure discussed previously. Further samples will be collected at 6 week and 3-month follow-ups and processed.
- Being tested
- Oxygen high-level laser therapy (Diode laser and hydrogen peroxide), Diode laser therapy
- Keywords
- photodynamic therapy, hydrogen peroxide, oxygen high-level laser therapy, microbiology, modified photodynamic therapy, diode laser
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen high-level laser therapy (Diode laser and hydrogen peroxide)Combination product
After mechanical debridement of the affected dental implant, a 3% hydrogen peroxide solution will be applied to the peri-implant pocket. This will be followed by irradiation using a diode laser at 940nm wavelength, applied for 60 seconds per site. The intervention will be performed in a single treatment session.
Diode laser therapyDevice
After mechanical debridement of the affected dental implant, irradiation using a diode laser at 940nm wavelength, applied for 60 seconds per site will be performed. This intervention will be administered in a single treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Diode laser and hydrogen peroxide | Active comparator | The dental implant will receive treatment using diode laser and hydrogen peroxide following mechanical debridement. Receives: Combination Product: Oxygen high-level laser therapy (Diode laser and hydrogen peroxide) |
| Diode laser | Active comparator | The dental implant will receive treatment using diode laser following mechanical debridement. Receives: Device: Diode laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth
Probing pocket depth (PPD): The distance from the gum margin to the bottom of the pocket around a tooth or implant using a periodontal probe.
Measurements were taken using PCPUNC 15 periodontal probe inserted parallel to the long axis of the implant until soft resistance was felt. Six sites per implant were recorded (mesiobuccal, mid-buccal, distobuccal, mesio-oral, mid-oral, disto-oral), and mean values were calculated. Higher values indicate deeper pockets and greater inflammation.
Unit of Measure: millimeters (mm)
Measured: From enrollment to the end of follow-ups at 3 months.
Bleeding on Probing
Bleeding on Probing (BOP): Percentage of sites exhibiting bleeding upon gentle probing around a tooth or implant using a periodontal probe. Each site was scored as bleeding (yes) or not bleeding (no) within 30 seconds after probing.
The percentage of bleeding sites was calculated as:
(number of bleeding sites ÷ total sites) × 100.
Higher percentages indicate greater inflammatory response. Unit of Measure: Percentage (%)
Measured: From enrollment to the end of follow-ups at 3 months
Gingival Index
Gingival index: A clinical measure used to assess the severity of gingival inflammation. It is based on the color, consistency, and bleeding of the gums when gently probed.
The scale ranges from 0 to 3, where:
0 = normal gingiva (no inflammation)
- = mild inflammation (slight color change, no bleeding on probing)
- = moderate inflammation (redness, edema, bleeding on probing)
- = severe inflammation (marked redness, ulceration, spontaneous bleeding)
Higher scores indicate more severe inflammation. Unit of Measure: Units on a scale (0-3)
Measured: From enrollment to the end of follow-ups at 3 months
Plaque Index
Plaque index: A scoring system used to measure the amount of dental plaque on the teeth or implants.
The scale ranges from 0 to 3, where:
0 = no plaque detected
- = plaque only detectable by probe
- = visible plaque
- = abundant plaque accumulation
Higher scores indicate greater plaque accumulation. Unit of Measure: Units on a scale (0-3)
Measured: From enrollment to the end of follow-ups at 3 months
Secondary outcomes (2)
Bacterial Load of Peri-Implant Pathogens (qPCR)
Quantitative measurement of target peri-implant bacteria (Porphyromonas gingivalis, Tannerella forsythia, Aggregatibacter actinomycetemcomitans, Fusobacterium nucleatum, Streptococcus mutans) using qPCR.
Unit of Measure: Copies per microliter (copies/µL)
Measured: From enrollment to the end of follow-ups at 3 months.
Suppuration
Suppuration was assessed by applying gentle pressure with a periodontal probe at six peri-implant sites.
Any detectable exudate or pus was recorded as "present"; absence of exudate was recorded as "absent." Presence of suppuration indicates active infection.
Unit of Measure: Presence/Absence (Yes/No)
Measured: From enrollment to the end of follow-ups at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start5 Feb 2024
- Primary completion7 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-Implantitis and Peri-implant MucositisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Rola Alhabashneh, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287956
- Sponsor's protocol ID
- 20240239
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Privacy and confidentiality of patients.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Adjunct Oxygen High-Level Laser Therapy on the Clinical and Microbiological Outcomes of Peri-implant Disease
- ClinicalTrials.gov ID
- NCT07287956
- Acronym / sponsor ID
- 20240239
- Keywords
- photodynamic therapy, hydrogen peroxide, oxygen high-level laser therapy, microbiology, modified photodynamic therapy, diode laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 17 Dec 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 learn whether using a special light-activated treatment called photodynamic therapy, or more specifically, its modified version called oxygen high-level laser therapy, using a high-powered diode laser along with 3% hydrogen peroxide, can improve gum health around dental implants. It tests whether adding this to regular cleaning treatments could reduce harmful bacteria and support better healing. The aim is to determine whether a specific protocol is an effective way to treat infections around dental implants.
Participants in the study will receive two types of treatment on different dental implants:
- One implant will be treated with the oxygen high-level laser therapy using diode laser and hydrogen peroxide after mechanical cleaning.
- The other implant will receive diode laser therapy without hydrogen peroxide after mechanical cleaning.
Researchers will compare how the gums respond to each treatment, looking at signs such as inflammation, and determine whether the number of harmful bacteria has been reduced at three time points.
Detailed description
Participants attending with at least two non-adjacent dental implants diagnosed with peri-implant disease (peri-implant mucositis and peri-implantitis) will be enrolled in the study. All patients included will be examined, and periodontal chartings will be obtained using a PCPUNC 15 probe. After routine phase one therapy (mechanical debridement using carbon-coated curettes on dental implants and ultrasonic scaling on the rest of the dentition), implant pocket irrigation using normal saline will be performed in both groups. Following irrigation using normal saline, implant pockets will be irrigated with 3% hydrogen peroxide, left in place for 2 minutes, and then irradiated with a 940nm diode laser (2.5W power, high frequency, 10 KHz, power average 0.5 W, fluency 25,000 J/cm2, 416.66 J/cm2 per second [Rey Protocol]) for 60 s per site in the test group. Control groups will receive mechanical debridement and diode laser treatment alone without the use of hydrogen peroxide.
Baseline clinical parameters will be measured at the initial visit and compared to post-treatment results at 6 weeks and 3 months. The clinical parameters to be evaluated include probing pocket depth, gingival index, plaque index, bleeding on probing, and suppuration.
In addition, microbiological parameters (bacterial count) using quantitative real-time polymerase chain reaction (qPCR) analysis will be determined from subgingival plaque samples using sterile paper points before and after treatment of both groups left in place for 30 seconds. Supragingival plaque is to be removed, and microbiological samples are to be taken before any measurements and/or non-surgical periodontal therapy (NSPT) from the deepest peri-implant pockets (sites are to be isolated with cotton rolls and gently air dried to avoid contamination with saliva). Immediately following treatment, a second swab will be taken from the implant surface using the same procedure discussed previously. Further samples will be collected at 6 week and 3-month follow-ups and processed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diode laser and hydrogen peroxide | Active comparator | Combination Product: Oxygen high-level laser therapy (Diode laser and hydrogen peroxide)The dental implant will receive treatment using diode laser and hydrogen peroxide following mechanical debridement. |
| Diode laser | Active comparator | Device: Diode laser therapyThe dental implant will receive treatment using diode laser following mechanical debridement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients 18 years or older.
- Patients diagnosed with peri-implant disease (peri-implant mucositis or peri-implantitis) according to the 2017 World Workshop criteria in at least two non-adjacent, single-crown, bone-level dental implants.
- Patients that have not undergone periodontal treatment and/or were prescribed antibiotics in the last three months prior to initial visit.
- Patients with a healthy periodontal status
- At least 1 year of functional implants.
Key exclusion criteria (4 listed)
- Immunocompromised patients.
- Pregnancy or breastfeeding.
- Known allergies to any materials used in the study.
- Patients classified as ASA Physical Status ≥ III.
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 |
|---|---|---|
| Oxygen high-level laser therapy (Diode laser and hydrogen peroxide)After mechanical debridement of the affected dental implant, a 3% hydrogen peroxide solution will be applied to the peri-implant pocket. This will be followed by irradiation using a diode laser at 940nm wavelength, applied for 60 seconds per site. The intervention will be performed in a single treatment session. | Combination product | Diode laser and hydrogen peroxide |
| Diode laser therapyAfter mechanical debridement of the affected dental implant, irradiation using a diode laser at 940nm wavelength, applied for 60 seconds per site will be performed. This intervention will be administered in a single treatment session. | Device | Diode laser |
Primary outcome
Probing Pocket Depth
Time frame: From enrollment to the end of follow-ups at 3 months.
Probing pocket depth (PPD): The distance from the gum margin to the bottom of the pocket around a tooth or implant using a periodontal probe. Measurements were taken using PCPUNC 15 periodontal probe inserted parallel to the long axis of the implant until soft resistance was felt. Six sites per implant were recorded (mesiobuccal, mid-buccal, distobuccal, mesio-oral, mid-oral, disto-oral), and mean values were calculated. Higher values indicate deeper pockets and greater inflammation. Unit of Measure: millimeters (mm)
Bleeding on Probing
Time frame: From enrollment to the end of follow-ups at 3 months
Bleeding on Probing (BOP): Percentage of sites exhibiting bleeding upon gentle probing around a tooth or implant using a periodontal probe. Each site was scored as bleeding (yes) or not bleeding (no) within 30 seconds after probing. The percentage of bleeding sites was calculated as: (number of bleeding sites ÷ total sites) × 100. Higher percentages indicate greater inflammatory response. Unit of Measure: Percentage (%)
Gingival Index
Time frame: From enrollment to the end of follow-ups at 3 months
Gingival index: A clinical measure used to assess the severity of gingival inflammation. It is based on the color, consistency, and bleeding of the gums when gently probed. The scale ranges from 0 to 3, where: 0 = normal gingiva (no inflammation) 1. = mild inflammation (slight color change, no bleeding on probing) 2. = moderate inflammation (redness, edema, bleeding on probing) 3. = severe inflammation (marked redness, ulceration, spontaneous bleeding) Higher scores indicate more severe inflammation. Unit of Measure: Units on a scale (0-3)
Plaque Index
Time frame: From enrollment to the end of follow-ups at 3 months
Plaque index: A scoring system used to measure the amount of dental plaque on the teeth or implants. The scale ranges from 0 to 3, where: 0 = no plaque detected 1. = plaque only detectable by probe 2. = visible plaque 3. = abundant plaque accumulation Higher scores indicate greater plaque accumulation. Unit of Measure: Units on a scale (0-3)
2 secondary outcomes
Bacterial Load of Peri-Implant Pathogens (qPCR)
Time frame: From enrollment to the end of follow-ups at 3 months.
Suppuration
Time frame: From enrollment to the end of follow-ups at 3 months
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 17 Dec 2025.
- Individual participant dataSharing planned: Undecided. Privacy and confidentiality of patients.
Related trials for Peri-Implantitis and Peri-implant Mucositis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingObservational study
Impact of Smoking on Immune Responses in Peri-implant Health and Disease
Peri-Implant Health, Peri Implant Mucositis
Not yet recruitingEarly Phase 1
Reconstructive Treatment of Peri-implantitis With Electrolytic Decontamination Versus Titanium Brushes
Peri-Implantitis and Peri-implant Mucositis
Active, not recruitingObservational study
Local and Systemic Inflammatory Bone Alterations Related to Dental Implant Survival.
Peri Implant Mucositis, Peri Implant Bone Loss
Active, not recruitingObservational study
Evaluation of aMMP-8 and IL-1β Levels and Marginal Bone Loss Associated With Peri-Implant Mucositis and Peri-Implantitis in Postmenopausal Women
Postmenopausal Peri-implant Health, Postmenopausal Peri-mucositis
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.
Rola Alhabashneh study chair
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen high-level laser therapy (Diode laser and hydrogen peroxide) and Diode laser therapy in people with Peri-Implantitis and Peri-implant Mucositis, run by King Abdullah University Hospital at 1 site in Jordan.
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 4 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 17 Dec 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 Jordan. 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. 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?
Probing Pocket Depth (time frame: From enrollment to the end of follow-ups at 3 months.). The study lists 4 primary outcomes in all. 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 17 Dec 2025.