NCT04149327

Systemic Amoxicillin Plus Metronidazole in Peri-implantitis Treatment

Systemic Antibiotic Therapy (Amoxicillin Plus Metronidazole) as an Adjunct to Initial Non-surgical Treatment of Peri-implantitis; a Single Blind Randomized Controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plus metronidazole therapy in conjunction with initial non-surgical treatment of peri-implantitis. The secondary objective is to assess the microbiological effectiveness of this peri-implantitis treatment approach. The present study is a single-blind, randomized controlled clinical trial. Adult patients with at least one endosseous implant in the oral cavity with clinical and radiographical evidence of periimplantitis will be included in this study. Patients with implants affected by peri-implantitis will receive initial periodontal treatment existing of oral hygiene instructions and mechanical cleansing of both implants and remaining dentition. Immediately after initial periodontal therapy patients will be instructed to rinse their mouth with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds for 2 weeks. Additionally patients will receive a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days or no recipe. The main study parameter is the mean peri-implant bleeding score.

Conditions

• Peri-implantitis
• Periodontal Diseases

Interventions

Type	Name	Description
DRUG	amoxicillin 500 mg + metronidazole 500 mg	500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for 7 days
PROCEDURE	non-surgical periodontal and peri-implant treatment	Patients are instructed on how to perform proper oral hygiene measures using an electric toothbrush, interdental brushes (to be used in combination with Corsodyl® gel) and floss (Oral-B® superfloss or Meridol® floss, at implants only). Patients will receive full-mouth mechanical cleansing of both implants and remaining dentition using ultrasonic instruments (EMS®) and hand instruments (scalers and curettes) in one or multiple sessions (max. 4). Prior to each session patients will rinse their mouth using 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol during 30 seconds. At the final session all previously cleaned areas will be re-examined and cleaned.

Timeline

• Start date: 2012-08-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2019-11-04
• Last updated: 2024-04-19