Implant Surface Decontamination in Peri-implantitis Treatment

• Sponsor: University Medical Center Groningen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01521260
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peri-implantitis; Periodontal Disease	Procedure: placebo; Procedure: Chlorhexidine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Perio-aid

Outcome Measures

Primary Outcome Measures

1. Change in Total Bacterial Load on the Exposed Implant Surface [During the surgical procedure: 1. immediately after flap deflection and granulation tissue removal AND 2. after the decontamination procedure but before flap closure.]

   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).

Secondary Outcome Measures

1. Bleeding on Probing [baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)]

2. Probing Pocket Depth [baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)]

3. Suppuration on Probing [baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)]

4. Microbiological Composition of the Peri-implant Sulcus [baseline (T0), 3 and 12 months after intervention (T3, T12)]

5. Radiographic Marginal Bone Level on Standardized Intraoral Radiographs [baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)]

6. Presence of Plaque [baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)]

7. Presence of Calculus [baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)]

8. Marginal Soft Tissue Recession [baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)]

9. Implant Failure [baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)]

   defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection

10. Complications and Adverse Events [baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands	9700RB

Sponsors and Collaborators

• University Medical Center Groningen

Investigators

• Principal Investigator: Yvonne CM de Waal, dds, University Medical Center Groningen
• Study Chair: Arie Jan van Winkelhoff, prof. dr., University Medical Center Groningen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yvonne CM de Waal, drs., University Medical Center Groningen
• ClinicalTrials.gov Identifier: NCT01521260
• Other Study ID Numbers: 27147.042.09
• First Posted: Jan 30, 2012
• Last Update Posted: Jul 2, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Yvonne CM de Waal, drs., University Medical Center Groningen: dental implants; microbiology; chlorhexidine
• Additional relevant MeSH terms: Periodontal Diseases; Peri-Implantitis; Chlorhexidine

Study Results

Participant Flow

Recruitment Details	recruitment period: october 2009-september 2010 location: University Medical Center Groningen
Pre-assignment Detail	Assessed for eligibility:55 patients Excluded 25, because 'not meeting inclusion criteria (n=20) or 'declined to participate' (n=5)

Arm/Group Title	Placebo Group	Chlorhexidine Group
Arm/Group 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, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.	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.
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo Group	Chlorhexidine Group	Total
Arm/Group 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, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.	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 of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 60%	9 60%	18 60%
>=65 years	6 40%	6 40%	12 40%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.5 (10.0)	59.4 (14.0)	60.4 (12.0)
Sex: Female, Male (Count of Participants)
Female	10 66.7%	10 66.7%	20 66.7%
Male	5 33.3%	5 33.3%	10 33.3%
Region of Enrollment (participants) [Number]
Netherlands	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Change in Total Bacterial Load on the Exposed Implant Surface
Description	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).
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Group	Chlorhexidine Group
Arm/Group 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, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.	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.
Measure Participants	15	15
Measure implants	35	25
Log Mean (Standard Deviation) [log (colony forming units/ml)]	2.77 (2.12)	4.21 (1.89)

2. Secondary Outcome

Title	Bleeding on Probing
Time Frame	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Probing Pocket Depth
Time Frame	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Suppuration on Probing
Time Frame	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Microbiological Composition of the Peri-implant Sulcus
Time Frame	baseline (T0), 3 and 12 months after intervention (T3, T12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Radiographic Marginal Bone Level on Standardized Intraoral Radiographs
Time Frame	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Presence of Plaque
Time Frame	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Presence of Calculus
Time Frame	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Marginal Soft Tissue Recession
Time Frame	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Implant Failure
Description	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	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	Complications and Adverse Events
Time Frame	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Placebo Group		Chlorhexidine Group
Arm/Group 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, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.		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.
All Cause Mortality
	Placebo Group		Chlorhexidine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo Group		Chlorhexidine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Group		Chlorhexidine Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.