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Implant Surface Decontamination in Peri-implantitis Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yvonne CM de Waal, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01521260
First received: January 18, 2012
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

Peri-implantitis is an 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, it is reasonable to anticipate an increasing prevalence of peri-implantitis. However, from the literature there is very little reliable evidence suggesting which could be the most effective interventions for treating peri-implantitis.

The primary objective of this controlled clinical study is to evaluate the microbiological effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a chlorhexidine or placebo solution. The secondary objectives are to assess both the clinical and the microbiological effectiveness of treatment of peri-implantitis.

It is hypothesized that rinsing of the implant surface using a 0.12% chlorhexidine solution does not lead to better microbiological and clinical results compared to rinsing with a placebo solution.

The present study is a double-blind, placebo-controlled, randomized clinical trial.

Adult patients with at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis will be included in this study.

Implants with peri-implantitis lesions will be surgically exposed, followed by mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline followed by either 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine) (control group) or 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) (test group). After 1 minute of saline rinsing the gingival flap will be returned slightly apical (in order to reduce pockets) and will be firmly sutured. For both groups the surgery is followed by 2 weeks of mouthrinses with 0,12% chlorhexidine + Cetylpyridinium Chloride (CPC) without alcohol (Perio-aid®) two times daily during 30 seconds.

The main study parameter is the microbial composition of the biofilm on the dental implant surface. Secondary study parameters are bleeding on probing, probing pocket depth, suppuration on probing, microbiological composition of the peri-implant sulcus, radiographic marginal bone level on standardized intraoral radiographs, presence of plaque, presence of calculus, marginal soft tissue recession implant failure, complications and adverse events.


Condition Intervention
Peri-implantitis
Periodontal Disease
 Procedure: placebo
Procedure: Chlorhexidine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Microbiological and Clinical Evaluation of Different Implant Surface Decontaminating Procedures in the Surgical Treatment of Peri-implantitis; a Double Blind Placebo Controlled Randomized Clinical Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Total bacterial load on the exposed implant surface [ Time Frame: During the surgical procedure: 1. immediately after flap deflection and granulation tissue removal AND 2. after the decontamination procedure but before flap closure. ] [ Designated as safety issue: No ]
    Total bacterial load as obtained by sweeping a microbrush across the implant surface after flap deflection. Samples are obtained immediately after flap deflection and granulation tissue removal AND after the decontamination procedure (mechanical debridement, rinsing of the implant surface using the placebo or chlorhexidine solution, saline rinsing) but before flap closure.


Secondary Outcome Measures:
  • Bleeding on probing [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ] [ Designated as safety issue: No ]
  • Probing pocket depth [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ] [ Designated as safety issue: No ]
  • Suppuration on probing [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ] [ Designated as safety issue: No ]
  • Microbiological composition of the peri-implant sulcus [ Time Frame: baseline (T0), 3 and 12 months after intervention (T3, T12) ] [ Designated as safety issue: No ]
  • Radiographic marginal bone level on standardized intraoral radiographs [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ] [ Designated as safety issue: No ]
  • presence of plaque [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ] [ Designated as safety issue: No ]
  • presence of calculus [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ] [ Designated as safety issue: No ]
  • marginal soft tissue recession [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ] [ Designated as safety issue: No ]
  • Implant failure [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo group
Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
 Procedure: placebo
Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
Active Comparator: Chlorhexidine group
Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
 Procedure: 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, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
Other Name: Perio-aid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is ≥ 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 ≥ 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 ≥ 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;
  • Diabetes;
  • Systemic use of antibiotics during the last 3 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 3 months;
  • Use of mouthrinses;
  • 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 curretage).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521260

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Yvonne CM de Waal, dds Universitair Medisch Centrum Groningen
Study Chair: Arie Jan van Winkelhoff, prof. dr. Universitair Medisch Centrum Groningen
  More Information

No publications provided

Responsible Party: Yvonne CM de Waal, drs., University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01521260     History of Changes
Other Study ID Numbers: 27147.042.09
Study First Received: January 18, 2012
Last Updated: January 25, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:
dental implants
microbiology
chlorhexidine

Additional relevant MeSH terms:
Periodontal Diseases
Peri-Implantitis
Mouth Diseases
Stomatognathic Diseases
Cetylpyridinium
Chlorhexidine
Chlorhexidine gluconate
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 22, 2013