Implant Surface Decontamination in Peri-implantitis Treatment

This study has been completed.
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: June 28, 2013
Last verified: June 2013
Results First Received: May 3, 2013  
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
Conditions: Peri-implantitis
Periodontal Disease
Interventions: Procedure: placebo
Procedure: Chlorhexidine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
recruitment period: october 2009-september 2010 location: University Medical Center Groningen

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Assessed for eligibility:55 patients Excluded 25, because 'not meeting inclusion criteria (n=20) or 'declined to participate' (n=5)

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Placebo Group     Chlorhexidine Group  
STARTED     15     15  
COMPLETED     15     15  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Placebo Group     Chlorhexidine Group     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     9     18  
>=65 years     6     6     12  
Age  
[units: years]
Mean ± Standard Deviation
  61.5  ± 10.0     59.4  ± 14.0     60.4  ± 12.0  
Gender  
[units: participants]
     
Female     10     10     20  
Male     5     5     10  
Region of Enrollment  
[units: participants]
     
Netherlands     15     15     30  



  Outcome Measures

1.  Primary:   Change in 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. ]

2.  Secondary:   Bleeding on Probing   [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Probing Pocket Depth   [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Suppuration on Probing   [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Microbiological Composition of the Peri-implant Sulcus   [ Time Frame: baseline (T0), 3 and 12 months after intervention (T3, T12) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Radiographic Marginal Bone Level on Standardized Intraoral Radiographs   [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Presence of Plaque   [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Presence of Calculus   [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Marginal Soft Tissue Recession   [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Implant Failure   [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Complications and Adverse Events   [ Time Frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Y.C.M. de Waal
Organization: University Medical Center Groningen - Center for dentistry and oral hygiene
phone: +31 50-3639051
e-mail: y.c.m.de.waal@umcg.nl


No publications provided


Responsible Party: Yvonne CM de Waal, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01521260     History of Changes
Other Study ID Numbers: 27147.042.09
Study First Received: January 18, 2012
Results First Received: May 3, 2013
Last Updated: June 28, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)