MucositisPhase 2NCT02605382
Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis
A Phase 2 study testing Chlorhexidine gluconate in people with Mucositis, run by Universidade Federal do Rio Grande do Norte.
Trial summary
The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a chemical adjuvant for the treatment of peri-implant mucositis, in a non-surgical treatment protocol with a six-month follow-up. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mucositis
- What is being tested?
- Chlorhexidine gluconate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Dec 2013
- Phase
- Phase 2
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically-healthy partially edentulous patients rehabilitated with functional dental implants and prostheses for at least 1 year;
- Patients had been diagnosed with peri-implant mucositis, probing depth up to 5 mm, bleeding on probing and no radiographic evidence of bone loss beyond the first two threads of the implant.
Who cannot join
- Non-smokers and not in maintenance therapy;
- Periodontal treatment during the last six months;
- Have not used antimicrobial (systemic or topical), anti-inflammatory or immunosuppressive drugs during the six months preceding the study.
About this study
Official title: Efficacy of 0.12% Chlorhexidine Gluconate for Non-surgical Treatment of Peri-implant Mucositis
The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a chemical adjuvant for the treatment of peri-implant mucositis, in a non-surgical treatment protocol with a six-month follow-up.
Read the detailed description
Determination of the sample size was based on the sample calculation for clinical trials, estimating a 50% success rate for the control group and 100% for the test group, which was then averaged for the two groups. With a standardized difference and power test of 85%, a total of 28 subjects per group were obtained.
Periapical radiographic examinations were performed before the collection of data to confirm the absence of bone loss, and threads exposition of the implants. The following clinical parameters were evaluated in both test and control groups; visible plaque index (VPI) and gingival bleeding index (GBI) were obtained for full mouth (IPV and ISG) and for each implant (VPI implant; GBI implant). For statistical purposes, percentages of faces with biofilm and marginal bleeding at teeth and implants were calculated. These parameters were evaluated at baseline and at one, three and six months post-therapy.
Keratinized mucosa width (KM), probing depth (PD implant), and bleeding on probing (BOP implant) were collected for all implants with a North Carolina periodontal probe at six sites. After data collection, an arithmetic averages of the sites with bleeding on probing, probing depths, and keratinized mucosa were calculated at baseline, three and six months. The peri-implant biotype for each implant was rated as thin or thick, according to probe transparency during probing depth.
Clinical parameters were collected by two operators, calibrated by the Kappa test for the keratinized mucosa, peri-implant biotype and probing depth.
After inclusion of the patients, anamnesis and initial examination were performed. The subjects were randomly divided, using a simple draw, in the following two groups: Test - (0.12% chlorhexidine digluconate associated with periodontal basic therapy) and Control - (placebo associated with periodontal basic therapy). Data were analyzed using descriptive and inferential statistics, with nonparametric tests, through a Statistical Package Social Sciences software (SPSS), version 17.0 (free version). The Friedman test was used for intragroup analysis and if any significant differences were observed, the Wilcoxon post-test was performed. Additionally, Mann-Whitney test was used for intergroup analysis. Chi-Square test was used to evaluate probing depth and bleeding on probing, according to the independent variables of interest: age, sex, treatment group, keratinized mucosa, peri-implant biotype, median VPI implant and GBI implant. Spearman correlation was also used to correlate probing depth and bleeding on probing after six months of follow-up. The implant was considered the unit of analysis and a value of p<0.05 was used to represent a statistically significant difference.
- Conditions
- Mucositis
- Being tested
- Chlorhexidine gluconate, placebo
- Keywords
- Dental Implantation, Chlorhexidine gluconate
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Also called Chlorhexidine
placeboDrug
Also called placebo solution
Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine gluconate | Experimental | 15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days Receives: Drug: Chlorhexidine gluconate |
| placebo | Placebo comparator | 15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
Measured: baseline
Bleeding on probing
Measured: three months
Bleeding on probing
Measured: six months
Secondary outcomes (1)
Probing depth
Measured: baseline and at three and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karyna de Melo Menezes, Universidade Federal do Rio Grande do Norte
- Investigators
- Bruno CV Gurgel, Doctor, Study director, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605382
- Sponsor's protocol ID
- UFRN
- Status last verified
- Nov 2015
- First submitted
- 7 Oct 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 0.12% Chlorhexidine Gluconate for Non-surgical Treatment of Peri-implant Mucositis
- ClinicalTrials.gov ID
- NCT02605382
- Acronym / sponsor ID
- UFRN
- Conditions
- Mucositis
- Keywords
- Dental Implantation, Chlorhexidine gluconate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Nov 2015 (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.
The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a chemical adjuvant for the treatment of peri-implant mucositis, in a non-surgical treatment protocol with a six-month follow-up.
Detailed description
Determination of the sample size was based on the sample calculation for clinical trials, estimating a 50% success rate for the control group and 100% for the test group, which was then averaged for the two groups. With a standardized difference and power test of 85%, a total of 28 subjects per group were obtained.
Periapical radiographic examinations were performed before the collection of data to confirm the absence of bone loss, and threads exposition of the implants. The following clinical parameters were evaluated in both test and control groups; visible plaque index (VPI) and gingival bleeding index (GBI) were obtained for full mouth (IPV and ISG) and for each implant (VPI implant; GBI implant). For statistical purposes, percentages of faces with biofilm and marginal bleeding at teeth and implants were calculated. These parameters were evaluated at baseline and at one, three and six months post-therapy.
Keratinized mucosa width (KM), probing depth (PD implant), and bleeding on probing (BOP implant) were collected for all implants with a North Carolina periodontal probe at six sites. After data collection, an arithmetic averages of the sites with bleeding on probing, probing depths, and keratinized mucosa were calculated at baseline, three and six months. The peri-implant biotype for each implant was rated as thin or thick, according to probe transparency during probing depth.
Clinical parameters were collected by two operators, calibrated by the Kappa test for the keratinized mucosa, peri-implant biotype and probing depth.
After inclusion of the patients, anamnesis and initial examination were performed. The subjects were randomly divided, using a simple draw, in the following two groups: Test - (0.12% chlorhexidine digluconate associated with periodontal basic therapy) and Control - (placebo associated with periodontal basic therapy). Data were analyzed using descriptive and inferential statistics, with nonparametric tests, through a Statistical Package Social Sciences software (SPSS), version 17.0 (free version). The Friedman test was used for intragroup analysis and if any significant differences were observed, the Wilcoxon post-test was performed. Additionally, Mann-Whitney test was used for intergroup analysis. Chi-Square test was used to evaluate probing depth and bleeding on probing, according to the independent variables of interest: age, sex, treatment group, keratinized mucosa, peri-implant biotype, median VPI implant and GBI implant. Spearman correlation was also used to correlate probing depth and bleeding on probing after six months of follow-up. The implant was considered the unit of analysis and a value of p<0.05 was used to represent a statistically significant difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine gluconate | Experimental | Drug: Chlorhexidine gluconate15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days |
| placebo | Placebo comparator | Drug: placebo15 ml of solution every 12 hours, twice a day, 30 minutes after brushing, for 14 days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Systemically-healthy partially edentulous patients rehabilitated with functional dental implants and prostheses for at least 1 year;
- Patients had been diagnosed with peri-implant mucositis, probing depth up to 5 mm, bleeding on probing and no radiographic evidence of bone loss beyond the first two threads of the implant.
Key exclusion criteria (3 listed)
- Non-smokers and not in maintenance therapy;
- Periodontal treatment during the last six months;
- Have not used antimicrobial (systemic or topical), anti-inflammatory or immunosuppressive drugs during the six months preceding the study.
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 |
|---|---|---|
| Chlorhexidine gluconateAlso: Chlorhexidine | Drug | chlorhexidine gluconate |
| placeboAlso: placebo solutionSolution chemical manufactured to mimic 0.12% chlorhexidine mouthwash | Drug | placebo |
Primary outcome
Bleeding on probing
Time frame: baseline
Bleeding on probing
Time frame: three months
Bleeding on probing
Time frame: six months
1 secondary outcome
Probing depth
Time frame: baseline and at three and six months
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 16 Nov 2015.
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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.
Bruno CV Gurgel, Doctor study director
Universidade Federal do Rio Grande do Norte
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chlorhexidine gluconate in people with Mucositis, run by Universidade Federal do Rio Grande do Norte.
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 2 inclusion and 3 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 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bleeding on probing (time frame: baseline). The study lists 3 primary outcomes in all. 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 16 Nov 2015.