None listed
Conditions
Interventions
Drug : In this clinical trial, participants in the experimental group received the combination antibiotic ointment MM-A (PERIMEDI®), while those in the control group received the single-component anti
Sponsors
Yonsei University Health System, Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants who met all of the following criteria were eligible for inclusion in the study 1. Participants with at least one implant meeting all of the following conditions 1) Probing depth (PD) of =8 mm at one or more of the six sites per tooth upon periodontal probing 2) Peri-implant bone loss of at least one-third of the implant length 3) Presence of bleeding on probing, spontaneous bleeding, or suppuration 2. Participants in whom a target site can be identified among implant sites diagnosed with peri-implantitis 1) The target site is defined as the site with the greatest probing depth among the six sites of the affected implant 2) If multiple sites have the same PD, the target site is selected based on the following priority: 3) Greater severity of bleeding or suppuration 4) Higher plaque index (PI) if bleeding/suppuration severity is similar 5) If all above are equal, selection is based on radiographic findings and prosthetic conditions, prioritizing measurement reproducibility 6) If measurement reproducibility is compromised (e.g., due to implant position, angulation, prosthesis design, anatomical factors, or investigator judgment), an alternative site may be selected, and the reason must be documented in the electronic case report form (e-CRF) 3. Participants whose implant diagnosed with peri-implantitis was placed at least 1 year prior to the screening visit 4. Participants who fully understand the purpose of the study, voluntarily agree to participate, and provide written informed consent while agreeing to comply with study requirements
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria were excluded from the study: 1. Participants who received any of the following medications prior to the first administration of the investigational product: 1) Medications that may affect periodontal conditions (e.g., phenytoin, calcium channel blockers(CCBs), cyclosporin, coumarin, non-steroidal anti-inflammatory drugs [NSAIDs]) for =5 consecutive days within 1 month prior to dosing(however, participants taking calcium channel blockers(CCBs) or aspirin =100 mg/day for =4 weeks without dose or regimen changes were allowed) 2) Antibiotics (e.g., minocycline, metronidazole, doxycycline) within 1 month prior to dosing 3) Medications for periodontal disease (e.g., Zea mays L. extract, products containing unsaponifiable corn extract such as Insadol®, Igatan®) within 3 weeks prior to dosing 2. Participants who had received surgical or other treatment for the implant diagnosed with peri-implantitis, or who were scheduled to undergo such treatment during the study period 3. Participants scheduled to undergo dental treatment or surgery on teeth other than the implant diagnosed with peri-implantitis during the study period (except when the treatment site was in a different quadrant) 4. Participants with any of the following conditions at screening, as judged by the investigator: 1) Severe systemic diseases (e.g., uncontrolled hypertension or diabetes) 2) Autoimmune diseases (e.g., rheumatoid arthritis, ankylosing spondylitis) 3) Uncontrolled bleeding disorders (e.g., platelet abnormalities, coagulation factor deficiencies) 5. Participants receiving medications containing warfarin or disulfiram at screening, or expected to require such medications during the study period, and unable to discontinue them 6. Participants with positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) at screening 7. Participants who smoke more than 10 cigarettes per day 8. Participants with a history or suspicion of drug abuse or alcohol abuse within 6 months prior to screening 9. Pregnant or breastfeeding women 10. Women and men of childbearing potential who plan to become pregnant during the study period or who are unwilling to use adequate contraception (acceptable methods include hormonal contraception, intrauterine devices or systems, double-barrier methods with spermicide, or surgical sterilization such as vasectomy or tubal ligation) 11. Participants with known hypersensitivity to the investigational product or its components (minocycline hydrochloride dihydrate, metronidazole benzoate, or minocycline hydrochloride) 12. Participants who participated in another clinical trial involving an investigational product or medical device within 30 days prior to screening 13. Participants deemed unsuitable for participation by the investigator for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Probing Depth (PD) at the Target Site at 12 weeks after the first administration of the investigational drug compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Probing Depth (PD) at the Target Site and all sites at 2, 4, 8, and 12 weeks after the first administration of the investigational drug compared to baseline; Change in Plaque Index (PI) at the Target Site and all sites at 2, 4, 8, and 12 weeks after the first administration of the investigational drug compared to baseline;Presence of bleeding at the Target Site at 2, 4, 8, and 12 weeks after the first administration of the investigational drug.; Change in the number of sites with bleeding across all sites at 2, 4, 8, and 12 weeks after the first administration of the investigational drug compared to baseline;Proportion of treatment responders at 2, 4, 8, and 12 weeks after the first administration of the investigational drug; Time (weeks) from baseline to the appearance of a treatment response;Change in Total Viable Count (TVC) of oral microorganisms at 4 and 12 weeks after first administration of investigational drug compared to baseline; Change in bone loss at 12 weeks after first administration of investigational drug compared to screening | — |
Countries
Korea, Republic of
Contacts
Public ContactChangsung Kim
Yonsei University Health System, Dental Hospital
Outcome results
None listed