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NCT Number: NCT01138943

Chlorhexidine Mouthrinses and Plaque Control

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).

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Key information

Conditions

Dental Plaque Dental Deposits Stomatognathic Diseases Tooth Diseases

Age range

20 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculté de Médecine Dentaire

Rabat, 10 000, Morocco

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synthodont

Drug

15 ml, tree times/day for 07 days

Arm: Chlorhexidine alcohol-base mouthrinse

Soludent

Drug

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

Arm: Experimental: non alcohol chlorhexidine mouthrinse

Primary outcomes

  1. 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.

Secondary outcomes

  1. Side effects

    Time frame: at day 7

    On Day 7, all subjects were examined for the presence or absence of tooth staining, and were questioned about taste disturbances and mucosal sensitivities.

Sponsors and collaborators

Lead sponsor

Hôpital Militaire De Rabat

Other

Collaborators

  • CCTD, Centre Hospitalier Ibn Sina,Morocco
  • Faculté de Médecine Dentaire de Rabat
  • Faculté de Médecine de Rabat
  • Mohammed V Souissi University

Registry information

Official study title

Chlorhexidine Alcohol Base Mouthrinse Versus Chlorhexidine Formaldehyde Base Mouthrinse Efficacy on Plaque Control: Double Blind, Randomized Clinical Trials

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jun 8, 2010
Registry last updated
May 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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