Clinical Trial: Surgical Treatment of Peri-implantitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Surgical Treatment of Peri-implantitis. A Randomised Controlled Trial.

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 Summary:

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, prob
Sponsor: Göteborg University

Current Primary Outcome:

  • pocket closure [ Time Frame: 6 months, 1 year ]
    absence of probing pocket depth > 5 mm and no bleeding on probing
  • bone level stability [ Time Frame: 1 year ]
    no further peri-implant marginal bone loss in the observation period.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: Göteborg University

Dates:
Date Received: April 14, 2017
Date Started: May 2017
Date Completion:
Last Updated: November 12, 2014
Last Verified: November 2014