Periodontal DiseasesNCT01852253
Implant Surface Decontamination With 2 % Chlorhexidine in Peri-implantitis Treatment
A study testing 2% chlorhexidine and 0.12% chlorhexidine in people with Periodontal Diseases and Peri-implantitis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Peri-implantitis is a 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, is it reasonable to anticipate an increasing prevalence of peri-implantitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontal Diseases, Peri-implantitis
- What is being tested?
- 2% chlorhexidine and 0.12% chlorhexidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient is at least 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 more than or equal to 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 more than or equal to 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;
- Insulin dependent diabetes;
- Systemic use of antibiotics during the last 2 months;
- Long-term use of anti-inflammatory drugs;
Show all 17Show 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 2 months;
- 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 curettage).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Microbiological Evaluation Implant Surface Decontamination With 2% Chlorhexidine in the Surgical Treatment of Peri-implantitis; a Double Blind Controlled Randomized Clinical Study
Peri-implantitis is a 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, is it reasonable to anticipate an increasing prevalence of peri-implantitis. This underlines the necessity for a predictable therapy. However, from the literature there is very little reliable evidence suggesting which could be the most effective interventions for treating periimplantitis.
The primary objective of this controlled clinical study is to evaluate the clinical effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution. The secondary objective is to assess the microbiological effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution.
The primary study parameter is the change from baseline in modified bleeding index. Secondary study parameters are: change in microbial composition of the biofilm covering the dental implant surface; microbiological composition of the peri-implant sulcus; change in probing pocket depth;change in suppuration on probing; change in radiographic marginal bone level on standardized intraoral radiographs; change in modified plaque index; 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; complications and adverse events. It is hypothesized that decontamination of the implant surface with 2% chlorhexidine leads to a greater decrease in modified bleeding index than decontamination with a 0.12% chlorhexidine solution.
- Conditions
- Periodontal Diseases, Peri-implantitis
- Being tested
- 2% chlorhexidine, 0.12% chlorhexidine
- Keywords
- Dental implants, Periodontal diseases, Peri-implantitis, Chlorhexidine, Microbiology
- Medical subject headings
- Periodontal Diseases, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% chlorhexidineProcedure or surgery
0.12% chlorhexidineProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 2% chlorhexidine | 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 and 1 minute of local application of a 2 % chlorhexidine solution. After 1 minute of saline rinsing the gingival flap will be returned slightly apical (in order to reduce pockets) and will be firmly sutured. The surgery is followed by 2 weeks of rinsing with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds. Receives: Procedure: 2% chlorhexidine |
| 0.12% chlorhexidine | Sham 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 and 1 minute of local application of a 0.12 % chlorhexidine solution. After 1 minute of saline rinsing the gingival flap will be returned slightly apical (in order to reduce pockets) and will be firmly sutured. The surgery is followed by 2 weeks of rinsing with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds. Receives: Procedure: 0.12% chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in modified bleeding index.
Measured: baseline, 3, 6 and 12 months after treatment
Secondary outcomes (7)
Change in microbial composition of the biofilm covering the dental implant surface
Measured: during treatment: 'after granulation tissue removal' and 'after mechanical and chemical decontamination procedure'
Microbiological composition of the peri-implant sulcus
Measured: before treatment and 3, 6 and 12 months after treatment
Change from baseline in probing pocket depth
Measured: baseline and 3, 6 and 12 months after treatment
Change from baseline in suppuration on probing
Measured: baseline and 3, 6 and 12 months after treatment
Change from baseline in radiographic marginal bone level on standardized intraoral radiographs
Measured: baseline and 3, 6 and 12 months after treatment
Change from baseline in modified plaque index
Measured: baseline and 3, 6 and 12 months after treatment
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: 3, 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startMar 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852253
- Sponsor's protocol ID
- 31262.042.10
- Status last verified
- Apr 2024
- First submitted
- 3 May 2013
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
de Waal YC, Raghoebar GM, Huddleston Slater JJ, Meijer HJ, Winkel EG, van Winkelhoff AJ. Implant decontamination during surgical peri-implantitis treatment: a randomized, double-blind, placebo-controlled trial. J Clin Periodontol. 2013 Feb;40(2):186-95. doi: 10.1111/jcpe.12034. Epub 2012 Dec 4.
PubMed 23211012de Waal YC, Raghoebar GM, Meijer HJ, Winkel EG, van Winkelhoff AJ. Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment: a randomized, double-blind, controlled trial. Clin Oral Implants Res. 2015 Sep;26(9):1015-23. doi: 10.1111/clr.12419. Epub 2014 May 26.
PubMed 24861411
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Evaluation Implant Surface Decontamination With 2% Chlorhexidine in the Surgical Treatment of Peri-implantitis; a Double Blind Controlled Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT01852253
- Acronym / sponsor ID
- 31262.042.10
- Conditions
- Periodontal Diseases, Peri-implantitis
- Keywords
- Dental implants, Periodontal diseases, Peri-implantitis, Chlorhexidine, Microbiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Not posted in the source record
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 a 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, is it reasonable to anticipate an increasing prevalence of peri-implantitis. This underlines the necessity for a predictable therapy. However, from the literature there is very little reliable evidence suggesting which could be the most effective interventions for treating periimplantitis.
The primary objective of this controlled clinical study is to evaluate the clinical effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution. The secondary objective is to assess the microbiological effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution.
The primary study parameter is the change from baseline in modified bleeding index. Secondary study parameters are: change in microbial composition of the biofilm covering the dental implant surface; microbiological composition of the peri-implant sulcus; change in probing pocket depth;change in suppuration on probing; change in radiographic marginal bone level on standardized intraoral radiographs; change in modified plaque index; 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; complications and adverse events. It is hypothesized that decontamination of the implant surface with 2% chlorhexidine leads to a greater decrease in modified bleeding index than decontamination with a 0.12% chlorhexidine solution.
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 |
|---|---|---|
| 2% chlorhexidine | Active comparator | Procedure: 2% chlorhexidineImplants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline and 1 minute of local application of a 2 % chlorhexidine solution. After 1 minute of saline rinsing the gingival flap will be returned slightly apical (in order to reduce pockets) and will be firmly sutured. The surgery is followed by 2 weeks of rinsing with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds. |
| 0.12% chlorhexidine | Sham comparator | Procedure: 0.12% chlorhexidineImplants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline and 1 minute of local application of a 0.12 % chlorhexidine solution. After 1 minute of saline rinsing the gingival flap will be returned slightly apical (in order to reduce pockets) and will be firmly sutured. The surgery is followed by 2 weeks of rinsing with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is at least 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 more than or equal to 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 more than or equal to 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 (17 listed)
- Medical and general contraindications for the surgical procedures;
- A history of local radiotherapy to the head and neck region;
- Pregnancy and lactation;
- Insulin dependent diabetes;
- Systemic use of antibiotics during the last 2 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 |
|---|---|---|
| 2% chlorhexidine | Procedure or surgery | 2% chlorhexidine |
| 0.12% chlorhexidine | Procedure or surgery | 0.12% chlorhexidine |
Primary outcome
Change from baseline in modified bleeding index.
Time frame: baseline, 3, 6 and 12 months after treatment
7 secondary outcomes
Change in microbial composition of the biofilm covering the dental implant surface
Time frame: during treatment: 'after granulation tissue removal' and 'after mechanical and chemical decontamination procedure'
Microbiological composition of the peri-implant sulcus
Time frame: before treatment and 3, 6 and 12 months after treatment
Change from baseline in probing pocket depth
Time frame: baseline and 3, 6 and 12 months after treatment
Change from baseline in suppuration on probing
Time frame: baseline and 3, 6 and 12 months after treatment
Change from baseline in radiographic marginal bone level on standardized intraoral radiographs
Time frame: baseline and 3, 6 and 12 months after treatment
Change from baseline in modified plaque index
Time frame: baseline and 3, 6 and 12 months after treatment
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
Time frame: 3, 6 and 12 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 23211012de Waal YC, Raghoebar GM, Huddleston Slater JJ, Meijer HJ, Winkel EG, van Winkelhoff AJ. Implant decontamination during surgical peri-implantitis treatment: a randomized, double-blind, placebo-controlled trial. J Clin Periodontol. 2013 Feb;40(2):186-95. doi: 10.1111/jcpe.12034. Epub 2012 Dec 4.
- Derived from this study: PubMed 24861411de Waal YC, Raghoebar GM, Meijer HJ, Winkel EG, van Winkelhoff AJ. Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment: a randomized, double-blind, controlled trial. Clin Oral Implants Res. 2015 Sep;26(9):1015-23. doi: 10.1111/clr.12419. Epub 2014 May 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% chlorhexidine and 0.12% chlorhexidine in people with Periodontal Diseases and Peri-implantitis, 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 17 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 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline in modified bleeding index. (time frame: baseline, 3, 6 and 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01852253, which also lists 2 linked publications.
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 19 Apr 2024.