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

Primary Purpose

Periodontal Diseases, Peri-implantitis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
2% chlorhexidine
0.12% chlorhexidine
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Dental implants, Periodontal diseases, Peri-implantitis, Chlorhexidine, Microbiology

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

2% chlorhexidine

0.12% chlorhexidine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in modified bleeding index.

Secondary Outcome Measures

Change in microbial composition of the biofilm covering the dental implant surface
Microbiological composition of the peri-implant sulcus
Change from baseline in probing pocket depth
Change from baseline in suppuration on probing
Change from baseline in radiographic marginal bone level on standardized intraoral radiographs
Change from baseline 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

Full Information

First Posted
May 3, 2013
Last Updated
May 10, 2013
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT01852253
Brief Title
Implant Surface Decontamination With 2 % Chlorhexidine in Peri-implantitis Treatment
Official Title
Clinical and Microbiological Evaluation Implant Surface Decontamination With 2% Chlorhexidine in the Surgical Treatment of Peri-implantitis; a Double Blind Controlled Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Peri-implantitis
Keywords
Dental implants, Periodontal diseases, Peri-implantitis, Chlorhexidine, Microbiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2% chlorhexidine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
0.12% chlorhexidine
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
2% chlorhexidine
Intervention Type
Procedure
Intervention Name(s)
0.12% chlorhexidine
Primary Outcome Measure Information:
Title
Change from baseline in modified bleeding index.
Time Frame
baseline, 3, 6 and 12 months after treatment
Secondary Outcome Measure Information:
Title
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'
Title
Microbiological composition of the peri-implant sulcus
Time Frame
before treatment and 3, 6 and 12 months after treatment
Title
Change from baseline in probing pocket depth
Time Frame
baseline and 3, 6 and 12 months after treatment
Title
Change from baseline in suppuration on probing
Time Frame
baseline and 3, 6 and 12 months after treatment
Title
Change from baseline in radiographic marginal bone level on standardized intraoral radiographs
Time Frame
baseline and 3, 6 and 12 months after treatment
Title
Change from baseline in modified plaque index
Time Frame
baseline and 3, 6 and 12 months after treatment
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 AV
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23211012
Citation
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. Erratum In: J Clin Periodontol. 2014 Jan;41(1):94.
Results Reference
background
PubMed Identifier
24861411
Citation
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.
Results Reference
derived

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

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