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Evaluation of the Clinical Efficacy of a Novel Non-Surgical Peri-Implantitis Treatment Using the Radical-Based Antibacterial Device

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	peri-implantitis
Date of first enrollment	19/02/2026
Target sample size	40
Countries of recruitment
Study type	Interventional
Intervention(s)	Test Group: Local anesthesia (2% lidocaine with 1:80,000 epinephrine) will be administered to the peri-implantitis site. After removal of the superstructure, the tip of the Blue Radical P-01 device will be positioned near the peri-implantitis site. By pressing the foot pedal, ultrasonic scaling will be performed in combination with laser irradiation (wavelength: 405 nm, output: 50 mW) for 5 minutes, while simultaneously irrigating with 3% hydrogen peroxide from the tip. After the procedure, the superstructure will be reattached. Analgesics will be prescribed as needed on a pro re nata (PRN) basis to manage any postoperative pain. Control Group: Local anesthesia (2% lidocaine with 1:80,000 epinephrine) will be administered to the peri-implantitis site. After removal of the superstructure, ultrasonic scaling will be performed using the Blue Radical P-01 for 5 minutes, with cooling water (tap water) used instead of hydrogen peroxide, and without laser irradiation (conventional treatment). After the procedure, the superstructure will be reattached. Analgesics will be prescribed as needed on a PRN basis to manage any postoperative pain.

Outcome(s)

Primary Outcome

Changes in peri-implant probing pocket depth (PPD) between baseline and 24 weeks after the intervention treatment.

Secondary Outcome

1.Clinical Efficacy Changes from baseline in the following parameters Probing pocket depth (PPD) at 12 weeks after the intervention Clinical attachment level (CAL) at 12 and 24 weeks after the intervention Measurements compared with baseline Presence or absence of bleeding on probing (BOP) at 12 and 24 weeks after the intervention Presence or absence of suppuration on probing at 12 and 24 weeks after the intervention Plaque Index (PlI) at 12 and 24 weeks after the intervention Gingival Index (GI) at 12 and 24 weeks after the intervention Width of keratinized gingiva at 12 and 24 weeks after the intervention Changes in subjective symptoms, assessed using a specialized symptom questionnaire, at 1, 12, and 24 weeks after the intervention compared with baseline, as well as participants impressions of the treatment. 2.Radiographic Evaluation Radiographic parameters compared with baseline Amount of supporting bone regeneration at 24 weeks after the intervention Changes in the morphology of bone defects (vertical , horizontal) at 24 weeks after the intervention 3.Safety Evaluation Assessment of subcutaneous emphysema and postoperative pain at 1 week after the intervention and any additional treatment Monitoring of adverse events up to 24 weeks after the intervention.

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	(1) Male or female patients aged 20 years or older at the time of obtaining written informed consent. (2) Patients who have dental implants in the molar region (either maxilla or mandible, unilateral or bilateral). (3) Patients diagnosed with peri implantitis. The definition of periimplantitis follows that of the 2017 World Workshop on the Classification of Periodontal and PeriImplant Diseases and Conditions, which includes, 1.Probing pocket depth (PPD) of 6 mm or more around the implant 2.Bleeding on probing (BOP) present 3.Presence or absence of suppuration is not considered 4. Radiographic evidence of bone loss of 3 mm or more (4) The implant fixture must be manufactured by a major company such as Nobel Biocare, Straumann, or Astra. (5) Patients with screw-retained implant-supported prostheses. (6) Patients capable of outpatient visits (Performance Status 0-2). (7) Patients who have voluntarily provided written informed consent to participate in this clinical study. (8) Patients whose Plaque Index (PlI) value at the target site is >= 1 on the day of registration.
Exclude criteria	(1) Patients exhibiting implant mobility. (2) Smokers. (3) Patients who have received subgingival peri-implantitis treatment within 4 weeks prior to the test or control treatment. (4) Patients who were diagnosed with generalized severe periodontitis (Stage IV, Grade C) at screening. (5) Patients whose adjacent teeth to the intervention target tooth were diagnosed with severe periodontitis (Stage IV, Grade C). (6) Patients who have difficulty performing oral hygiene as instructed by a dentist or dental hygienist. (7) Patients currently undergoing radiation therapy or chemotherapy. (8) Patients using bisphosphonate preparations. (9) Patients currently taking or expected to take steroidal anti-inflammatory drugs, or non-steroidal anti-inflammatory drugs (NSAIDs) continuously for more than 4 days during the study period. (10) Patients taking medications that may affect the clinical manifestations of periodontal disease (such as antiepileptic drugs, immunosuppressants, or calcium channel blockers). (11) Patients with a history of photosensitivity. (12) Patients with acatalasemia. (13) Patients with a cardiac pacemaker. (14) Female patients who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding. (15) Any other patients deemed unsuitable for participation by the principal investigator or sub-investigator.