MedDataX Logo

The Use of Adjunct Oxygen High-Level Laser Therapy on the Clinical and Microbiological Outcomes of Peri-implant Disease

NCT ID: NCT07287956

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2025-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peri-Implantitis and Peri-implant Mucositis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

photodynamic therapy hydrogen peroxide oxygen high-level laser therapy microbiology modified photodynamic therapy diode laser

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diode laser and hydrogen peroxide

The dental implant will receive treatment using diode laser and hydrogen peroxide following mechanical debridement.

Group Type ACTIVE_COMPARATOR

Oxygen high-level laser therapy (Diode laser and hydrogen peroxide)

Intervention Type 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

The dental implant will receive treatment using diode laser following mechanical debridement.

Group Type ACTIVE_COMPARATOR

Diode laser therapy

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type COMBINATION_PRODUCT

Diode laser therapy

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Immunocompromised patients.
* Pregnancy or breastfeeding.
* Known allergies to any materials used in the study.
* Patients classified as ASA Physical Status ≥ III.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jordan University of Science and Technology

OTHER

Sponsor Role collaborator

King Abdullah University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rola Alhabashneh

Role: STUDY_CHAIR

Jordan University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jordan University of Science and Technology

Irbid, Alabama, Jordan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Jordan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20240239

Identifier Type: -

Identifier Source: org_study_id