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

April 17, 2024 updated by: University Medical Center Groningen

Clinical and Microbiological Evaluation Implant Surface Decontamination With 2% Chlorhexidine in the Surgical Treatment of Peri-implantitis; a Double Blind Controlled Randomized Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 AV
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Previous surgical treatment of the peri-implantitis lesions;
  • Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curettage).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2% chlorhexidine
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
Sham Comparator: 0.12% chlorhexidine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in modified bleeding index.
Time Frame: baseline, 3, 6 and 12 months after treatment
baseline, 3, 6 and 12 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in microbial composition of the biofilm covering the dental implant surface
Time Frame: during treatment: 'after granulation tissue removal' and 'after mechanical and chemical decontamination procedure'
during treatment: 'after granulation tissue removal' and 'after mechanical and chemical decontamination procedure'
Microbiological composition of the peri-implant sulcus
Time Frame: before treatment and 3, 6 and 12 months after treatment
before treatment and 3, 6 and 12 months after treatment
Change from baseline in probing pocket depth
Time Frame: baseline and 3, 6 and 12 months after treatment
baseline and 3, 6 and 12 months after treatment
Change from baseline in suppuration on probing
Time Frame: baseline and 3, 6 and 12 months after treatment
baseline and 3, 6 and 12 months after treatment
Change from baseline in radiographic marginal bone level on standardized intraoral radiographs
Time Frame: baseline and 3, 6 and 12 months after treatment
baseline and 3, 6 and 12 months after treatment
Change from baseline in modified plaque index
Time Frame: baseline and 3, 6 and 12 months after treatment
baseline and 3, 6 and 12 months after treatment
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
Time Frame: 3, 6 and 12 months after treatment
3, 6 and 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimated)

May 13, 2013

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31262.042.10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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