Chlorhexidine Mouthrinses and Plaque Control
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention |
|---|---|
|
Dental Plaque |
Drug: Synthodont Drug: Soludent |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Chlorhexidine Alcohol Base Mouthrinse Versus Chlorhexidine Formaldehyde Base Mouthrinse Efficacy on Plaque Control: Double Blind, Randomized Clinical Trials |
- Plaque Index (PI)at Day 1 and Day 7. [ Time Frame: one week ] [ Designated as safety issue: No ]
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.
- Side effects [ Time Frame: at day 7 ] [ Designated as safety issue: No ]On Day 7, all subjects were examined for the presence or absence of tooth staining, and were questioned about taste disturbances and mucosal sensitivities.
| Enrollment: | 30 |
| Study Start Date: | February 2007 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Chlorhexidine alcohol-base mouthrinse |
Drug: Synthodont
15 ml, tree times/day for 07 days Arm: Chlorhexidine alcohol-base mouthrinse Other Name: Synthodont
|
| Experimental: non alcohol chlorhexidine mouthrinse |
Drug: Soludent
15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days Arm: Experimental: non alcohol chlorhexidine mouthrinse Other Name: Soludent
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- give written informed consent before entering the study
- accept to stop tooth cleaning for a week
Exclusion Criteria:
- 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
Contacts and Locations| Morocco | |
| Faculté de Médecine Dentaire | |
| Rabat, Morocco, 10 000 | |
| Study Chair: | Oumkeltoum Ennibi, Professor | Faculté de Médecine Dentaire |
More Information
No publications provided
| Responsible Party: | Ennibi Oumkeltoum , Head of clinical Department of Periodontology, Faculté de Médecine Dentaire de Rabat |
| ClinicalTrials.gov Identifier: | NCT01138943 History of Changes |
| Other Study ID Numbers: | 1251/10, 1171 |
| Study First Received: | June 7, 2010 |
| Last Updated: | May 13, 2011 |
| Health Authority: | Morocco: Ministry of Public Health |
Keywords provided by Hôpital Militaire De Rabat:
|
Chlorhexidine mouthrinse Plaque control |
Additional relevant MeSH terms:
|
Dental Plaque Dental Deposits Tooth Diseases Stomatognathic Diseases Chlorhexidine Chlorhexidine gluconate |
Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Disinfectants Dermatologic Agents |
ClinicalTrials.gov processed this record on May 21, 2013