Implant Surface Decontamination in Peri-implantitis Treatment

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01521260

Enrollment

Registered

2012-01-30

Start date

2009-10-31

Completion date

2011-09-30

Last updated

2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implantitis, Periodontal Disease

Keywords

dental implants, microbiology, chlorhexidine

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.

Interventions

PROCEDUREplacebo

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.

PROCEDUREChlorhexidine

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)	—
Bleeding on Probing	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)	—
Presence of Calculus	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)	—
Marginal Soft Tissue Recession	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)	—
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
Complications and Adverse Events	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)	—
Presence of Plaque	baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)	—

Countries

Netherlands

Participant flow

Recruitment details

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

Pre-assignment details

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

Participants by arm

Arm	Count
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.	15
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.	15
Total	30

Baseline characteristics

Characteristic	Chlorhexidine Group	Placebo Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	6 Participants	6 Participants	12 Participants
Age, Categorical Between 18 and 65 years	9 Participants	9 Participants	18 Participants
Age, Continuous	59.4 years STANDARD_DEVIATION 14	61.5 years STANDARD_DEVIATION 10	60.4 years STANDARD_DEVIATION 12
Region of Enrollment Netherlands	15 participants	15 participants	30 participants
Sex: Female, Male Female	10 Participants	10 Participants	20 Participants
Sex: Female, Male Male	5 Participants	5 Participants	10 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 15	0 / 15
serious Total, serious adverse events	0 / 15	0 / 15

Outcome results

Primary

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).

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.

Arm	Measure	Value (LOG_MEAN)	Dispersion
Placebo Group	Change in Total Bacterial Load on the Exposed Implant Surface	2.77 log (colony forming units/ml)	Standard Deviation 2.12
Chlorhexidine Group	Change in Total Bacterial Load on the Exposed Implant Surface	4.21 log (colony forming units/ml)	Standard Deviation 1.89

Secondary