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NCT Number: NCT01852253

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

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Peri-Implantitis Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9713 AV, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

2% chlorhexidine

Procedure

0.12% chlorhexidine

Procedure

Primary outcomes

  1. Change from baseline in modified bleeding index.

    Time frame: baseline, 3, 6 and 12 months after treatment

Secondary outcomes

  1. 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'

  2. Microbiological composition of the peri-implant sulcus

    Time frame: before treatment and 3, 6 and 12 months after treatment

  3. Change from baseline in probing pocket depth

    Time frame: baseline and 3, 6 and 12 months after treatment

  4. Change from baseline in suppuration on probing

    Time frame: baseline and 3, 6 and 12 months after treatment

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

    Time frame: baseline and 3, 6 and 12 months after treatment

  6. Change from baseline in modified plaque index

    Time frame: baseline and 3, 6 and 12 months after treatment

  7. 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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 13, 2013
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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