Peri-implantitisNCT01521260
Implant Surface Decontamination in Peri-implantitis Treatment
A study testing Chlorhexidine in people with Peri-implantitis and Periodontal Disease, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implantitis, Periodontal Disease
- What is being tested?
- Chlorhexidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- placebo, Chlorhexidine
- Keywords
- dental implants, microbiology, chlorhexidine
- Medical subject headings
- Peri-Implantitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboProcedure or surgery
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.
ChlorhexidineProcedure or surgery
Also called Perio-aid
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Probing Pocket Depth
Measured: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Suppuration on Probing
Measured: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Microbiological Composition of the Peri-implant Sulcus
Measured: baseline (T0), 3 and 12 months after intervention (T3, T12)
Radiographic Marginal Bone Level on Standardized Intraoral Radiographs
Measured: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Presence of Plaque
Measured: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Presence of Calculus
Measured: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Marginal Soft Tissue Recession
Measured: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Implant Failure
defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection
Measured: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Complications and Adverse Events
Measured: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startOct 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yvonne CM de Waal, dds, Principal investigator, University Medical Center GroningenArie Jan van Winkelhoff, prof. dr., Study chair, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521260
- Sponsor's protocol ID
- 27147.042.09
- Status last verified
- Apr 2024
- First submitted
- 18 Jan 2012
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01521260
- Acronym / sponsor ID
- 27147.042.09
- Conditions
- Peri-implantitis, Periodontal Disease
- Keywords
- dental implants, microbiology, chlorhexidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Posted 2 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Procedure: placeboImplants 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 | Active comparator | Procedure: ChlorhexidineImplants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboImplants 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 or surgery | Placebo group |
| ChlorhexidineAlso: Perio-aidImplants 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 or surgery | Chlorhexidine group |
Primary outcome
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.
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).
10 secondary outcomes
Bleeding on Probing
Time frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Probing Pocket Depth
Time frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Suppuration on Probing
Time frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Microbiological Composition of the Peri-implant Sulcus
Time frame: baseline (T0), 3 and 12 months after intervention (T3, T12)
Radiographic Marginal Bone Level on Standardized Intraoral Radiographs
Time frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Presence of Plaque
Time frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Presence of Calculus
Time frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Marginal Soft Tissue Recession
Time frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Implant Failure
Time frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Complications and Adverse Events
Time frame: baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne CM de Waal, dds principal investigator
University Medical Center Groningen
Arie Jan van Winkelhoff, prof. dr. study chair
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine in people with Peri-implantitis and Periodontal Disease, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.