peri-implantitis
Conditions
Interventions
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 wi
Sponsors
Yoda Nobuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in peri-implant probing pocket depth (PPD) between baseline and 24 weeks after the intervention treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactTaichi Tenkumo
Tohoku University Hospital
Outcome results
None listed