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

NCT07287956 | Completed FDA Device

• 1 other identifier: 20240239
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Peri-Implantitis and Peri-implant Mucositis

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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)

  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 (%)

  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) 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)

  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 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)

  From enrollment to the end of follow-ups at 3 months

Secondary Outcomes (2)

• Bacterial Load of Peri-Implant Pathogens (qPCR)

  From enrollment to the end of follow-ups at 3 months.

• Suppuration

  From enrollment to the end of follow-ups at 3 months

Study Arms (2)

Diode laser and hydrogen peroxide

ACTIVE COMPARATOR

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

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.

Device: Diode laser therapy

Interventions

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 and hydrogen peroxide

Diode laser therapy 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.

Diode laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, Alabama, 22110, Jordan

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Lasers, Semiconductor; Hydrogen Peroxide

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Organic Chemicals

Study Officials

• Rola Alhabashneh

  Jordan University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: December 17, 2025
• Study Start: February 5, 2024
• Primary Completion: July 7, 2025
• Study Completion: August 1, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-08

Locations

JO (1)