Chlorhexidine Mouthrinses and Plaque Control

NCT ID: NCT01138943

Last Updated: 2011-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-04-30

Brief Summary

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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

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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

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Dental Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Chlorhexidine alcohol-base mouthrinse

Group Type ACTIVE_COMPARATOR

Synthodont

Intervention Type DRUG

15 ml, tree times/day for 07 days

Arm: Chlorhexidine alcohol-base mouthrinse

non alcohol chlorhexidine mouthrinse

Group Type EXPERIMENTAL

Soludent

Intervention Type DRUG

15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days

Arm: Experimental: non alcohol chlorhexidine mouthrinse

Interventions

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Synthodont

15 ml, tree times/day for 07 days

Arm: Chlorhexidine alcohol-base mouthrinse

Intervention Type DRUG

Soludent

15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days

Arm: Experimental: non alcohol chlorhexidine mouthrinse

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CCTD, Centre Hospitalier Ibn Sina,Morocco

UNKNOWN

Sponsor Role collaborator

Faculté de Médecine Dentaire de Rabat

UNKNOWN

Sponsor Role collaborator

Faculté de Médecine de Rabat

UNKNOWN

Sponsor Role collaborator

Mohammed V Souissi University

OTHER

Sponsor Role collaborator

Hôpital Militaire De Rabat

OTHER

Sponsor Role lead

Responsible Party

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Faculté de Médecine Dentaire de Rabat

Principal Investigators

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Oumkeltoum Ennibi, Professor

Role: STUDY_CHAIR

Faculté de Médecine Dentaire

Locations

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Faculté de Médecine Dentaire

Rabat, , Morocco

Site Status

Countries

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Morocco

Other Identifiers

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1171

Identifier Type: OTHER

Identifier Source: secondary_id

1251/10

Identifier Type: -

Identifier Source: org_study_id

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