A Phase 4 interventional study of Amoxicillin and Chlorhexidine gluconate in Peri-Implantitis, sponsored by Göteborg University. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2014-11-13.
Sponsored by Göteborg University · Phase 4, Interventional, and Treatment
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.
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 :
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.
304 studies on the registry are indexed under Peri-Implantitis; 84 are open to participants now.
This study's enrollment of 100 is above the median of 40 across 182 interventional studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with chlorhexidine gluconate 0,2%
Drug: Amoxicillin · Drug: Chlorhexidine gluconate
systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with saline
Drug: Amoxicillin
no systemic antibiotics + implant surface decontamination with chlorhexidine gluconate 0,2%
Drug: Chlorhexidine gluconate
no systemic antibiotics + implant surface decontamination with saline
Drug: Saline
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)
Also known as: systemic antibiotics
The exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine gluconate 0,2%) during the surgical treatment
Also known as: chlorhexidine gluconate 0,2%
The exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment
pocket closure
absence of probing pocket depth \> 5 mm and no bleeding on probing
Time frame: 6 months, 1 year
bone level stability
no further peri-implant marginal bone loss in the observation period.
Time frame: 1 year
Quantitative and qualitative change in levels of the peri-implant microflora
Quantitative and qualitative change in levels of the peri-implant microflora
Time frame: 3 months, 6 months, 1 year
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Göteborg University