Implant Surface Decontamination With 2 % Chlorhexidine in Peri-implantitis Treatment

NCT01852253 | Completed

• 1 other identifier: 31262.042.10
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-implantitis is a infectious disease that resides in the mucosa surrounding dental implants and also affects the supporting bone. Because the number of implants placed in everyday clinical practice is continuously increasing, is it reasonable to anticipate an increasing prevalence of peri-implantitis. This underlines the necessity for a predictable therapy. However, from the literature there is very little reliable evidence suggesting which could be the most effective interventions for treating periimplantitis. The primary objective of this controlled clinical study is to evaluate the clinical effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution. The secondary objective is to assess the microbiological effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution. The primary study parameter is the change from baseline in modified bleeding index. Secondary study parameters are: change in microbial composition of the biofilm covering the dental implant surface; microbiological composition of the peri-implant sulcus; change in probing pocket depth;change in suppuration on probing; change in radiographic marginal bone level on standardized intraoral radiographs; change in modified plaque index; implant failure, defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection; complications and adverse events. It is hypothesized that decontamination of the implant surface with 2% chlorhexidine leads to a greater decrease in modified bleeding index than decontamination with a 0.12% chlorhexidine solution.

Conditions

Periodontal Diseases; Peri-implantitis

Keywords

Dental implants; Periodontal diseases; Peri-implantitis; Chlorhexidine; Microbiology

Outcome Measures

Primary Outcomes (1)

• Change from baseline in modified bleeding index.

  baseline, 3, 6 and 12 months after treatment

Secondary Outcomes (7)

• Change in microbial composition of the biofilm covering the dental implant surface

  during treatment: 'after granulation tissue removal' and 'after mechanical and chemical decontamination procedure'

• Microbiological composition of the peri-implant sulcus

  before treatment and 3, 6 and 12 months after treatment

• Change from baseline in probing pocket depth

  baseline and 3, 6 and 12 months after treatment

• Change from baseline in suppuration on probing

  baseline and 3, 6 and 12 months after treatment

• Change from baseline in radiographic marginal bone level on standardized intraoral radiographs

  baseline and 3, 6 and 12 months after treatment

Study Arms (2)

2% chlorhexidine

ACTIVE COMPARATOR

Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline and 1 minute of local application of a 2 % chlorhexidine solution. After 1 minute of saline rinsing the gingival flap will be returned slightly apical (in order to reduce pockets) and will be firmly sutured. The surgery is followed by 2 weeks of rinsing with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds.

Procedure: 2% chlorhexidine

0.12% chlorhexidine

SHAM COMPARATOR

Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline and 1 minute of local application of a 0.12 % chlorhexidine solution. After 1 minute of saline rinsing the gingival flap will be returned slightly apical (in order to reduce pockets) and will be firmly sutured. The surgery is followed by 2 weeks of rinsing with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds.

Procedure: 0.12% chlorhexidine

Interventions

2% chlorhexidine PROCEDURE

2% chlorhexidine

0.12% chlorhexidine PROCEDURE

0.12% chlorhexidine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is at least 18 years of age;
• The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as a loss of marginal bone more than or equal to 2 mm as compared to a fixed reference point on the dental implant, in combination with bleeding and/or suppuration on probing and a peri-implant probing depth more than or equal to 5 mm;
• The implants have been exposed to the oral environment for at least two years;
• The patient is capable of understanding and giving informed consent.

You may not qualify if:

• Medical and general contraindications for the surgical procedures;
• A history of local radiotherapy to the head and neck region;
• Pregnancy and lactation;
• Insulin dependent diabetes;
• Systemic use of antibiotics during the last 2 months;
• Long-term use of anti-inflammatory drugs;
• Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
• Active, uncontrolled periodontal pathology of the remaining dentition;
• Local use of antibiotics or use of other anti-septic / antimicrobial therapies in the oral cavity during the last 2 months;
• Bruxism;
• Implants placed in skin grafted areas;
• Implants with bone loss due to other reasons than bacterial infection (e.g. loose screw, inadequate positioning of the implant);
• Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants;
• Implant mobility;
• Implants at which no position can be identified where proper probing measurements can be performed;

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 AV, Netherlands

Location

Related Publications (2)

• de Waal YC, Raghoebar GM, Huddleston Slater JJ, Meijer HJ, Winkel EG, van Winkelhoff AJ. Implant decontamination during surgical peri-implantitis treatment: a randomized, double-blind, placebo-controlled trial. J Clin Periodontol. 2013 Feb;40(2):186-95. doi: 10.1111/jcpe.12034. Epub 2012 Dec 4.

  PMID: 23211012 BACKGROUND

• de Waal YC, Raghoebar GM, Meijer HJ, Winkel EG, van Winkelhoff AJ. Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment: a randomized, double-blind, controlled trial. Clin Oral Implants Res. 2015 Sep;26(9):1015-23. doi: 10.1111/clr.12419. Epub 2014 May 26.

  PMID: 24861411 DERIVED

MeSH Terms

Conditions

Periodontal Diseases; Peri-Implantitis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 13, 2013
• Study Start: March 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

NL (1)