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A Comparison of Mouth Rinse Containing Alcohol-free Chlorhexidine With a Cetylpyridinium Chloride in Periodontal Diseases

Phase 2
Completed
Conditions
Periodontal Diseases
Interventions
Registration Number
NCT02756377
Lead Sponsor
Islamic Azad University, Tehran
Brief Summary

Aim: clinical effectiveness of 0.05% cetylpyridinium chloride mouth rinse in patients with gingivitis as compared to non-alcoholic chlorhexidine mouth wash.

Methods \& Material: Twenty-four subjects, without systemic diseases, with plaque-induced gingivitis will be selected for this study. The patients were treated with scaling and root planing at the baseline; Oral hygiene instructions were given that included brushing twice- daily, The volunteers brushed their teeth with the Bass brushing technique for at least 2 minutes, these patients were randomly ,equally divided into two groups, Group A: perform daily mouthwashes twice a day with the solution containing 10 ml of 0.05 cetyl pyridinium, (Vi-one, Rojin, Cosmetic-Lab, Kurdistan -Iran), Group B: use daily mouthwashes twice a day with 10ml of the chlorhexidine(Kin Laboratories, Spain), On day 0,7,15 and day 21 of each phase the Plaque Index (PI), Pocket depth(PD), Stain Index(SI) and Bleeding Index (BI) of each volunteer were measured.

Detailed Description

In this study, 34 patients referred to periodontics Department that no serious systemic disease in terms of periodontitis and disease Gingivitis (ie pockets of periodontal tissue to a depth of less than or equal to 4 mm without CAL in the jaw down or up) the following explanation necessary for the procedure tastings consent, the index of oral hygiene (plaque index) index # Turesky, pocket depth and to control the inflammatory condition \* bleeding index bleeding during the probe based on Carter and Barnes (if any bleeding number 1 and its absence 0) and attachment loss were evaluated areas. The amount of pigment (Stain) after of using mouthwash based on S.I (Stain Index) was evaluated .

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
34
Inclusion Criteria

Inclusion criteria: adult patients with gingivitis, older than 18 years old, systemically healthy, and having at least 20 teeth.

Exclusion Criteria

patients with cavitated caries, no periodontal pockets larger than 4 mm, orthodontic appliances or removable prostheses, allergies to cetyl pyridinium or CHX, use of antibiotics and anti-inflammatory drugs in the past 3 months that might alter normal gingival health, oral prophylaxis outside of study; use of oral chlorhexidine products or participation in an oral rinse study within 3 months prior to baseline examination, pregnancy or nursing, smoking.

Study Population 34 eligibles were enrolled in the study, was designed as a Randomized, Double-blind clinical trials.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Chlorhexidine mouthwashcetylpyridinium chloride mouthwashmouthwash ( Alcohol-free chlorhexidine)10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
cetylpyridinium chloridecetylpyridinium chloride mouthwashmouthwash (cetylpyridinium chloride)10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
cetylpyridinium chlorideChlorhexidine mouthwashmouthwash (cetylpyridinium chloride)10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
Primary Outcome Measures
NameTimeMethod
Reduction of bleeding on probing7 days

Periodontal pobe

Secondary Outcome Measures
NameTimeMethod
Reduction of plaque index7 days

Plaque Index (O'Leary)

Reduction of pocket depth7days

Periodontal pobe

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