Systemic Amoxicillin Plus Metronidazole in Peri-implantitis Treatment

NCT ID: NCT04149327

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-01
• Study Completion Date: 2019-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Antibiotics group

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. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days plus a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks.

Group Type: EXPERIMENTAL

amoxicillin 500 mg + metronidazole 500 mg

Intervention Type: DRUG

500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for 7 days

non-surgical periodontal and peri-implant treatment

Intervention Type: PROCEDURE

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.

Control group

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. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks.

Group Type: ACTIVE_COMPARATOR

non-surgical periodontal and peri-implant treatment

Intervention Type: PROCEDURE

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.

Interventions

amoxicillin 500 mg + metronidazole 500 mg

500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for 7 days

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The patient is ≥ 18 years of age;
• The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as a loss of marginal bone ≥ 2 mm as compared to the shoulder of the implant (the level at which the bone is normally located immediately after implant placement), in combination with bleeding and/or suppuration on probing and a peri-implant probing depth ≥ 5 mm;
• The implants have been in function for at least two years;
• The patient is capable of understanding and giving informed consent.

Exclusion Criteria

• Medical and general contraindications for the surgical procedures;
• A history of local radiotherapy to the head and neck region;
• Pregnancy and lactation;
• Uncontrolled diabetes (HbA1c < 7% or < 53 mmol/mol)
• Mononucleosis infectiosa
• Organic neurological disorders
• Use of antibiotics during the last 3 months;
• Known allergy to amoxicillin, metronidazole or chlorhexidine;
• Long-term use of anti-inflammatory drugs;
• Full edentulism (no remaining teeth, only implants)
• Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
• Implants placed in areas augmented with autogenous bone from the crista iliac region;
• Implants placed in skin grafted areas;
• Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants;
• Implant mobility;
• Implants at which no position can be identified where proper probing measurements can be performed;
• Previous surgical treatment of the peri-implantitis lesions;
• Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curettage)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NL41441.042.12

Identifier Type: -

Identifier Source: org_study_id