Dental PlaquePhase 3NCT02656251
Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation
A Phase 3 study testing 0.12% Clorhexidine with alcohol and 0.12% Clorhexidine without alcohol in people with Dental Plaque, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The aim of the study is to compare the effect of a suspension containing chlorhexidine and alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival biofilm formation versus a Placebo suspension. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- 0.12% Clorhexidine with alcohol and 0.12% Clorhexidine without alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Dec 2015
- Phase
- Phase 3
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age from 18 years;
- non-smokers;
- have good general health;
- present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis.
Who cannot join
- • positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation;
- positive history of allergies at using Triclosan;
- pregnant or lactating patients;
- patients in use of fixed orthodontic appliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation
The aim of the study is to compare the effect of a suspension containing chlorhexidine and alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).
Read the detailed description
This is a double blind, cross over, randomized clinical trial. 35 volunteers will stop mechanical supragingival biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. During this period they will be asked to rinse for a minute a Solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free or placebo. Every 24h the presence of deposits will be registered with special attention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006). The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. Sample size was calculated taking the results from the study o MALISKA, AN (2006) as reference.
- Conditions
- Dental Plaque
- Being tested
- 0.12% Clorhexidine with alcohol, placebo, 0.12% Clorhexidine without alcohol
- Keywords
- biofilms, cross over trial, chlorhexidine
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.12% Clorhexidine with alcoholDrug
Also called Periogard, No plak
Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
placeboDrug
Use of placebo every 12 hours for 04 days
0.12% Clorhexidine without alcoholDrug
Also called Periogard
Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days
| Study group | Role | What they receive |
|---|---|---|
| 0.12% Clorhexidine with alcohol | Active comparator | 0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days Receives: Drug: 0.12% Clorhexidine with alcohol; Drug: placebo; Drug: 0.12% Clorhexidine without alcohol |
| 0.12% Clorhexidine without alcohol | Experimental | 0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days Receives: Drug: 0.12% Clorhexidine with alcohol; Drug: placebo; Drug: 0.12% Clorhexidine without alcohol |
| control | Placebo comparator | placebo 15ml every 12 hour for 4 days Receives: Drug: 0.12% Clorhexidine with alcohol; Drug: placebo; Drug: 0.12% Clorhexidine without alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index.
The presence of scores 0, 1 or 2 of the index "Plaque Free Zone" will be recorded at baseline and at each 24 hours, during a period of 96 hours (4 days).
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Weidlich, Federal University of Rio Grande do Sul
- Investigators
- Patricia Weidlich, PhD, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656251
- Sponsor's protocol ID
- URio Grande
- Status last verified
- Jan 2016
- First submitted
- 18 Nov 2015
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation
- ClinicalTrials.gov ID
- NCT02656251
- Acronym / sponsor ID
- URio Grande
- Conditions
- Dental Plaque
- Keywords
- biofilms, cross over trial, chlorhexidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Jan 2016 (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 aim of the study is to compare the effect of a suspension containing chlorhexidine and alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).
Detailed description
This is a double blind, cross over, randomized clinical trial. 35 volunteers will stop mechanical supragingival biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. During this period they will be asked to rinse for a minute a Solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free or placebo. Every 24h the presence of deposits will be registered with special attention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006). The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. Sample size was calculated taking the results from the study o MALISKA, AN (2006) as reference.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.12% Clorhexidine with alcohol | Active comparator | Drug: 0.12% Clorhexidine with alcohol, Drug: placebo, Drug: 0.12% Clorhexidine without alcohol0.12% Clorhexidine with alcohol, 15ml every 12 hour for 4 days |
| 0.12% Clorhexidine without alcohol | Experimental | Drug: 0.12% Clorhexidine with alcohol, Drug: placebo, Drug: 0.12% Clorhexidine without alcohol0.12% Clorhexidine without alcohol, 15ml every 12 hour for 4 days |
| control | Placebo comparator | Drug: 0.12% Clorhexidine with alcohol, Drug: placebo, Drug: 0.12% Clorhexidine without alcoholplacebo 15ml every 12 hour for 4 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age from 18 years;
- non-smokers;
- have good general health;
- present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis.
Key exclusion criteria (4 listed)
- • positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation;
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 |
|---|---|---|
| 0.12% Clorhexidine with alcoholAlso: Periogard, No plakUse of 0.12% Clorhexidine with alcohol every 12 hours for 04 days | Drug | 0.12% Clorhexidine with alcohol, 0.12% Clorhexidine without alcohol, control |
| placeboUse of placebo every 12 hours for 04 days | Drug | 0.12% Clorhexidine with alcohol, 0.12% Clorhexidine without alcohol, control |
| 0.12% Clorhexidine without alcoholAlso: PeriogardUse of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days | Drug | 0.12% Clorhexidine with alcohol, 0.12% Clorhexidine without alcohol, control |
Primary outcome
Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index.
Time frame: 24hours
The presence of scores 0, 1 or 2 of the index "Plaque Free Zone" will be recorded at baseline and at each 24 hours, during a period of 96 hours (4 days).
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 14 Jan 2016.
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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.
Patricia Weidlich, PhD study director
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.12% Clorhexidine with alcohol and 0.12% Clorhexidine without alcohol in people with Dental Plaque, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 4 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 14 Jan 2016. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index. (time frame: 24hours). 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 14 Jan 2016.