Surgical Treatment of Peri-implantitis

Surgical Treatment of Peri-implantitis With and Without Adjunctive Use of Antibiotics : a Controlled and Randomized Clinical Study

Sponsors

Lead Sponsor: Göteborg University

Collaborator: The Swedish Research Council

Source Göteborg University
Brief Summary

The objective of this randomized controlled clinical trial is to evaluate the outcome of treatment of peri-implantitis with or without systemic antibiotics.

Specific aims are to analyze (i) the effect of systemic antibiotics and local antiseptics on the healing process, and (ii) the risk for recurrence of disease following surgical treatment of peri-implantitis.

Detailed Description

The study is designed as a randomized controlled clinical trial. 100 patients with severe peri-implantitis at one or more implants needing surgical treatment will be recruited. All individuals have to show unremarkable general health and not been using any antibiotics during the 6 months preceding the current examination.

The patients will be randomly assigned to the following :

- test group (T) : surgical treatment with systemic antibiotics,

- control group (C) : surgical treatment without systemic antibiotics. A stratification protocol will be applied regarding distribution of smokers. Two subgroups will be formed among test and control subjects.

- saline group (T1 and C1) : the exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment, and,

- antiseptics group (T2 and C2) : the exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine 0,2%) during the surgical treatment.

A stratification protocol will be applied regarding distribution of smokers.

Following the baseline examination, patients will randomly be assigned to the various treatment group. Samples from the subgingival microbiota will be obtained before surgical therapy.

All patients will be enrolled in a hygiene program including professional supragingival implant/tooth cleaning using rubber cups and polishing paste and oral hygiene instructions.

The following clinical parameters will be measured at baseline using a periodontal probe: plaque index, Bleeding on Probing, probing depth measured from the mucosal margin to the bottom of the probable pocket and mucosal recession measured from a fixed landmark on the implant to the mucosal margin.

The measurements will be made at 4 aspects of each implant. In the test group (T) a systemic antibiotic regimen will be initiated at 3 days before surgery and continued for 10 days. (2 x 750mg amoxicillin/day or 2 x 1g amoxicillin/day depending on the weight of the patient) Intra-oral radiographs will be taken at 2 weeks and 1 year after surgical therapy.

The professional implant/tooth cleaning and reinforcement of oral hygiene will be performed at 2 weeks, 1, 2, 3, 6, and 12 months after treatment.

Examination of clinical outcome variables will be performed at 3, 6 and 12 months after surgical therapy. Microbiological samples will be obtained at the same time points. Radiographs are taken 2 weeks post surgical and at the one year examination.

Primary outcomes variables include: (i) clinical signs of resolution of peri-implantitis (pocket closure and absence of BoP), (ii) recurrence of the disease (BoP and increase in PPD) and (iii) further loss in marginal bone support, and (iiii) microbiological findings.

Overall Status Completed
Start Date January 2013
Completion Date November 2014
Primary Completion Date November 2014
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
pocket closure 6 months, 1 year
bone level stability 1 year
Secondary Outcome
Measure Time Frame
Quantitative and qualitative change in levels of the peri-implant microflora 3 months, 6 months, 1 year
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Amoxicillin

Description: In the test group a systemic antibiotic regimen will be initiated at 3 days before surgery and continued for 10 days. (2 x 750mg amoxicillin/day or 2 x 1g amoxicillin/day depending on the weight of the patient)

Other Name: systemic antibiotics

Intervention Type: Drug

Intervention Name: Chlorhexidine gluconate

Description: The exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine gluconate 0,2%) during the surgical treatment

Other Name: chlorhexidine gluconate 0,2%

Intervention Type: Drug

Intervention Name: Saline

Description: The exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment

Arm Group Label: no antibiotics and no local antiseptics

Eligibility

Criteria:

Inclusion Criteria:

- peri-implant probing pocket depth > 7 mm on at least one aspect of the implant, together with BOP and/or suppuration,

- marginal bone loss > 3mm as detected in radiographs.

Exclusion Criteria:

- implant mobility,

- peri-implantitis associated bone defects not suitable for pocket elimination therapy,

- systemic diseases that could influence the outcome of the therapy,

- penicillin allergy.

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Tord Berglundh, Professor Study Chair Department of Periodontology, Institute of Odontology, The sahlgrenska academy, University of Gothenburg
Location
Facility: Department of Periodontology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg
Location Countries

Sweden

Verification Date

November 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: antibiotics and local antiseptics

Type: Experimental

Description: systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with chlorhexidine gluconate 0,2%

Label: antibiotics without local antiseptics

Type: Experimental

Description: systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with saline

Label: local antiseptics no antibiotics

Type: Experimental

Description: no systemic antibiotics + implant surface decontamination with chlorhexidine gluconate 0,2%

Label: no antibiotics and no local antiseptics

Type: Placebo Comparator

Description: no systemic antibiotics + implant surface decontamination with saline

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov