Implant Surface Decontamination in Peri-implantitis Treatment

NCT01521260 | Completed Results

• 1 other identifier: 27147.042.09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-implantitis; Periodontal Disease

Keywords

dental implants; microbiology; chlorhexidine

Outcome Measures

Primary Outcomes (1)

• Change in Total Bacterial Load on the Exposed Implant Surface

  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. The log-transformed mean change in bacterial load is calculated (difference between the two time points --\> difference in sample BEFORE decontamination and AFTER decontamination procedure).

  During the surgical procedure: 1. immediately after flap deflection and granulation tissue removal AND 2. after the decontamination procedure but before flap closure.

Secondary Outcomes (10)

• Bleeding on Probing

  baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

• Probing Pocket Depth

  baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

• Suppuration on Probing

  baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

• Microbiological Composition of the Peri-implant Sulcus

  baseline (T0), 3 and 12 months after intervention (T3, T12)

• Radiographic Marginal Bone Level on Standardized Intraoral Radiographs

  baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

Study Arms (2)

Placebo group

PLACEBO 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, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.

Procedure: placebo

Chlorhexidine group

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, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.

Procedure: Chlorhexidine

Interventions

placebo PROCEDURE

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.

Placebo group

Chlorhexidine PROCEDURE

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.

Also known as: Perio-aid

Chlorhexidine group

Eligibility Criteria

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

You may qualify if:

• 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.

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;
• 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;

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Peri-Implantitis; Periodontal Diseases

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Y.C.M. de Waal
• Organization: University Medical Center Groningen - Center for dentistry and oral hygiene

y.c.m.de.waal@umcg.nl

+31 50-3639051

Study Officials

• Yvonne CM de Waal, dds

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Arie Jan van Winkelhoff, prof. dr.

  University Medical Center Groningen

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

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: January 18, 2012
• First Posted: January 30, 2012
• Study Start: October 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 18, 2024
• Results First Posted: July 2, 2013

Record last verified: 2024-04

Locations

NL (1)