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Surgical Treatment of Peri-implantitis

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ClinicalTrials.gov Identifier: NCT01857804
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : November 13, 2014
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Peri-Implantitis Drug: Amoxicillin Drug: Chlorhexidine gluconate Drug: Saline Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Surgical Treatment of Peri-implantitis With and Without Adjunctive Use of Antibiotics : a Controlled and Randomized Clinical Study
Study Start Date : January 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014


Arm Intervention/treatment
Experimental: antibiotics and local antiseptics
systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with chlorhexidine gluconate 0,2%
Drug: Amoxicillin
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

Drug: Chlorhexidine gluconate
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%

Experimental: antibiotics without local antiseptics
systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with saline
Drug: Amoxicillin
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

Experimental: local antiseptics no antibiotics
no systemic antibiotics + implant surface decontamination with chlorhexidine gluconate 0,2%
Drug: Chlorhexidine gluconate
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%

Placebo Comparator: no antibiotics and no local antiseptics
no systemic antibiotics + implant surface decontamination with saline
Drug: Saline
The exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment




Primary Outcome Measures :
  1. pocket closure [ Time Frame: 6 months, 1 year ]
    absence of probing pocket depth > 5 mm and no bleeding on probing

  2. bone level stability [ Time Frame: 1 year ]
    no further peri-implant marginal bone loss in the observation period.


Secondary Outcome Measures :
  1. Quantitative and qualitative change in levels of the peri-implant microflora [ Time Frame: 3 months, 6 months, 1 year ]
    Quantitative and qualitative change in levels of the peri-implant microflora



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857804


Locations
Sweden
Department of Periodontology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg
Gothenburg, Sweden, 40530
Sponsors and Collaborators
Göteborg University
The Swedish Research Council
Investigators
Study Chair: Tord Berglundh, Professor Department of Periodontology, Institute of Odontology, The sahlgrenska academy, University of Gothenburg

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01857804     History of Changes
Other Study ID Numbers: olivier1
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014

Keywords provided by Göteborg University:
peri-implantitis
surgical therapy
systemic antibiotics
local antiseptics

Additional relevant MeSH terms:
Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Amoxicillin
Antibiotics, Antitubercular
Chlorhexidine gluconate
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Antitubercular Agents
Disinfectants
Dermatologic Agents