Trial Outcomes & Findings for Implant Surface Decontamination in Peri-implantitis Treatment (NCT NCT01521260)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

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

Results posted on

2024-04-18

Participant Flow

recruitment period: october 2009-september 2010 location: University Medical Center Groningen

Assessed for eligibility:55 patients Excluded 25, because 'not meeting inclusion criteria (n=20) or 'declined to participate' (n=5)

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Implant Surface Decontamination in Peri-implantitis Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Group n=15 Participants 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 n=15 Participants 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 n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	61.5 years STANDARD_DEVIATION 10.0 • n=5 Participants	59.4 years STANDARD_DEVIATION 14.0 • n=7 Participants	60.4 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Netherlands	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Placebo Group n=35 implants 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 n=25 implants 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.
Change in Total Bacterial Load on the Exposed Implant Surface	2.77 log (colony forming units/ml) Standard Deviation 2.12	4.21 log (colony forming units/ml) Standard Deviation 1.89

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

Adverse Events

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chlorhexidine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Y.C.M. de Waal

University Medical Center Groningen - Center for dentistry and oral hygiene

Phone: +31 50-3639051

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place