Surgical Treatment of Peri-implantitis

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857804
• Other study ID #: olivier1
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2013
• Last updated: November 12, 2014
• Start date: January 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

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)
• Chlorhexidine gluconate
The exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine gluconate 0,2%) during the surgical treatment
• Saline
The exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment

Locations

Country	Name	City	State
Sweden	Department of Periodontology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (10)

Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Implant surface characteristics influence the outcome of treatment of peri-implantitis: an experimental study in dogs. J Clin Periodontol. 2011 Jan;38(1):58-64. doi: 10.1111/j.1600-051X.2010.01631.x. Epub 2010 Nov 24. — View Citation

Ericsson I, Persson LG, Berglundh T, Edlund T, Lindhe J. The effect of antimicrobial therapy on periimplantitis lesions. An experimental study in the dog. Clin Oral Implants Res. 1996 Dec;7(4):320-8. — View Citation

Gualini F, Berglundh T. Immunohistochemical characteristics of inflammatory lesions at implants. J Clin Periodontol. 2003 Jan;30(1):14-8. — View Citation

Leonhardt A, Dahlén G, Renvert S. Five-year clinical, microbiological, and radiological outcome following treatment of peri-implantitis in man. J Periodontol. 2003 Oct;74(10):1415-22. — View Citation

Mombelli A, Feloutzis A, Brägger U, Lang NP. Treatment of peri-implantitis by local delivery of tetracycline. Clinical, microbiological and radiological results. Clin Oral Implants Res. 2001 Aug;12(4):287-94. English, French, German. — View Citation

Mombelli A, Lang NP. Antimicrobial treatment of peri-implant infections. Clin Oral Implants Res. 1992 Dec;3(4):162-8. — View Citation

Persson LG, Ericsson I, Berglundh T, Lindhe J. Guided bone regeneration in the treatment of periimplantitis. Clin Oral Implants Res. 1996 Dec;7(4):366-72. — View Citation

Persson LG, Ericsson I, Berglundh T, Lindhe J. Osseintegration following treatment of peri-implantitis and replacement of implant components. An experimental study in the dog. J Clin Periodontol. 2001 Mar;28(3):258-63. — View Citation

Persson LG, Mouhyi J, Berglundh T, Sennerby L, Lindhe J. Carbon dioxide laser and hydrogen peroxide conditioning in the treatment of periimplantitis: an experimental study in the dog. Clin Implant Dent Relat Res. 2004;6(4):230-8. — View Citation

Wetzel AC, Vlassis J, Caffesse RG, Hämmerle CH, Lang NP. Attempts to obtain re-osseointegration following experimental peri-implantitis in dogs. Clin Oral Implants Res. 1999 Apr;10(2):111-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pocket closure	absence of probing pocket depth > 5 mm and no bleeding on probing	6 months, 1 year	No
Primary	bone level stability	no further peri-implant marginal bone loss in the observation period.	1 year	No
Secondary	Quantitative and qualitative change in levels of the peri-implant microflora	Quantitative and qualitative change in levels of the peri-implant microflora	3 months, 6 months, 1 year	No