Dental PlaqueNCT01138943
Chlorhexidine Mouthrinses and Plaque Control
A study testing Synthodont and Soludent in people with Dental Plaque, run by Hôpital Militaire De Rabat at 1 site in Morocco.
Trial summary
The aim of the present study was to compare antiplaque effectiveness of two commercial mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine non-alcohol base with 0.1% of Formaldehyde (CLX-F). Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Synthodont and Soludent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMorocco
- Study dates
- Feb 2007to Apr 2007
- 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 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- give written informed consent before entering the study
- accept to stop tooth cleaning for a week
Who cannot join
- less than 20 teeth;
- presence of periodontal disease
- presence of factors of plaque retention (clinically unacceptable restorations, important carious, dental overlapping, removable prosthesis, faulty fixed prosthesis, orthodontic appliances),
- associated systemic diseases (diabetes, heart disorders, blood diseases, HIV infection),
- use of antibiotics or other anti-inflammatory drugs during the latest months,
- known allergy against components of mouth rinses,
- pregnancy,
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chlorhexidine Alcohol Base Mouthrinse Versus Chlorhexidine Formaldehyde Base Mouthrinse Efficacy on Plaque Control: Double Blind, Randomized Clinical Trials
The aim of the present study was to compare antiplaque effectiveness of two commercial mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine non-alcohol base with 0.1% of Formaldehyde (CLX-F).
Read the detailed description
Chlorhexidine (CLX) mouthrinse has been the gold standard as antiplaque solution.However, if its efficiency seems to be preserved even if the chlorhexidine concentration is bellow 0.10%, the formulation of the final product may affect the effectiveness. Thus, it can be concluded from this study that 0.12% CLX alcohol base mouthrinse is significantly more effective in inhibiting plaque than the diluted 0.1% CLX non-alcohol base containing formaldehyde mouthrinse.
- Conditions
- Dental Plaque
- Being tested
- Synthodont, Soludent
- Keywords
- Chlorhexidine mouthrinse, Plaque control
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynthodontDrug
15 ml, tree times/day for 07 days
Arm: Chlorhexidine alcohol-base mouthrinse
SoludentDrug
15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days
Arm: Experimental: non alcohol chlorhexidine mouthrinse
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine alcohol-base mouthrinse | Active comparator | Not described Receives: Drug: Synthodont |
| non alcohol chlorhexidine mouthrinse | Experimental | Not described Receives: Drug: Soludent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index (PI)at Day 1 and Day 7.
The clinical trial lasted 7 days (from Day 0 to Day 7). During this period all participants abstained from all mechanical oral hygiene procedures.
On Day 0, subjects were randomly distributed in three groups: two test groups and one negative control group, and were instructed to rinse twice daily with the allocated mouthrinse during the experimental period.
The clinical measurement: Plaque Index (PI) was recorded on Day 1 and Day 7.
Measured: one week
Secondary outcomes (1)
Side effects
On Day 7, all subjects were examined for the presence or absence of tooth staining, and were questioned about taste disturbances and mucosal sensitivities.
Measured: at day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startFeb 2007
- Primary completionMar 2007
- Study completionApr 2007
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Militaire De Rabat
- Sponsor type
- University, hospital or other
- Collaborators
- CCTD, Centre Hospitalier Ibn Sina,Morocco, Faculté de Médecine Dentaire de Rabat, Faculté de Médecine de Rabat, Mohammed V Souissi University
- Investigators
- Oumkeltoum Ennibi, Professor, Study chair, Faculté de Médecine Dentaire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138943
- Sponsor's protocol ID
- 1251/10
- Other IDs
- 1171
- Status last verified
- Feb 2007
- First submitted
- 7 Jun 2010
- Last updated
- 16 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine Alcohol Base Mouthrinse Versus Chlorhexidine Formaldehyde Base Mouthrinse Efficacy on Plaque Control: Double Blind, Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT01138943
- Acronym / sponsor ID
- 1251/10
- Conditions
- Dental Plaque
- Keywords
- Chlorhexidine mouthrinse, Plaque control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hôpital Militaire De RabatUniversity, hospital or other
- Collaborators
- CCTD, Centre Hospitalier Ibn Sina,Morocco, Faculté de Médecine Dentaire de Rabat, Faculté de Médecine de Rabat, Mohammed V Souissi University
- Study start
- Feb 2007
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 8 Jun 2010 (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 present study was to compare antiplaque effectiveness of two commercial mouthrinses: 0.12 % Chlorhexidine alcohol base (CLX-A) versus a diluted 0.1% Chlorhexidine non-alcohol base with 0.1% of Formaldehyde (CLX-F).
Detailed description
Chlorhexidine (CLX) mouthrinse has been the gold standard as antiplaque solution.However, if its efficiency seems to be preserved even if the chlorhexidine concentration is bellow 0.10%, the formulation of the final product may affect the effectiveness. Thus, it can be concluded from this study that 0.12% CLX alcohol base mouthrinse is significantly more effective in inhibiting plaque than the diluted 0.1% CLX non-alcohol base containing formaldehyde mouthrinse.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine alcohol-base mouthrinse | Active comparator | Drug: Synthodont |
| non alcohol chlorhexidine mouthrinse | Experimental | Drug: Soludent |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- give written informed consent before entering the study
- accept to stop tooth cleaning for a week
Key exclusion criteria (8 listed)
- less than 20 teeth;
- presence of periodontal disease
- presence of factors of plaque retention (clinically unacceptable restorations, important carious, dental overlapping, removable prosthesis, faulty fixed prosthesis, orthodontic appliances),
- associated systemic diseases (diabetes, heart disorders, blood diseases, HIV infection),
- use of antibiotics or other anti-inflammatory drugs during the latest 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 |
|---|---|---|
| Synthodont15 ml, tree times/day for 07 days Arm: Chlorhexidine alcohol-base mouthrinse | Drug | Chlorhexidine alcohol-base mouthrinse |
| Soludent15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days Arm: Experimental: non alcohol chlorhexidine mouthrinse | Drug | non alcohol chlorhexidine mouthrinse |
Primary outcome
Plaque Index (PI)at Day 1 and Day 7.
Time frame: one week
The clinical trial lasted 7 days (from Day 0 to Day 7). During this period all participants abstained from all mechanical oral hygiene procedures. On Day 0, subjects were randomly distributed in three groups: two test groups and one negative control group, and were instructed to rinse twice daily with the allocated mouthrinse during the experimental period. The clinical measurement: Plaque Index (PI) was recorded on Day 1 and Day 7.
1 secondary outcome
Side effects
Time frame: at day 7
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 May 2011.
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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.
Oumkeltoum Ennibi, Professor study chair
Faculté de Médecine Dentaire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synthodont and Soludent in people with Dental Plaque, run by Hôpital Militaire De Rabat at 1 site in Morocco.
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 8 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 May 2011. 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 Morocco. 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. 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?
Plaque Index (PI)at Day 1 and Day 7. (time frame: one week). 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 May 2011.