Department of Periodontology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg
Gothenburg, 40530, Sweden
NCT Number: NCT01857804
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Phase 4
Gothenburg, 40530, Sweden
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: systemic antibiotics
The exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine gluconate 0,2%) during the surgical treatment
Other names: chlorhexidine gluconate 0,2%
The exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment
Time frame: 6 months, 1 year
absence of probing pocket depth > 5 mm and no bleeding on probing
Time frame: 1 year
no further peri-implant marginal bone loss in the observation period.
Time frame: 3 months, 6 months, 1 year
Quantitative and qualitative change in levels of the peri-implant microflora
Göteborg University
Other
Surgical Treatment of Peri-implantitis With and Without Adjunctive Use of Antibiotics : a Controlled and Randomized Clinical Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06083246
Mouth Diseases, Peri-Implantitis
Pavia, Lombardy, Italy
View Trial DetailsNCT05024760
Dental Implant Failed, Implant Infection
Tacoma, Washington, United States
View Trial DetailsNCT07700628
Mouth Diseases, Peri-Implantitis
Caserta, CE, Italy
View Trial DetailsNCT07678892
Mouth Diseases, Peri-Implantitis
Kristianstad, Sweden
View Trial Details