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

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

PHASE2/PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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cetylpyridinium chloride

mouthwash (cetylpyridinium chloride)10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.

Group Type ACTIVE_COMPARATOR

cetylpyridinium chloride mouthwash

Intervention Type DRUG

cetylpyridinium chloride mouthwash, 10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.

Chlorhexidine mouthwash

Intervention Type DRUG

Chlorhexidine mouthwash,10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.

Chlorhexidine mouthwash

mouthwash ( Alcohol-free chlorhexidine)10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.

Group Type ACTIVE_COMPARATOR

cetylpyridinium chloride mouthwash

Intervention Type DRUG

cetylpyridinium chloride mouthwash, 10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.

Interventions

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cetylpyridinium chloride mouthwash

cetylpyridinium chloride mouthwash, 10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.

Intervention Type DRUG

Chlorhexidine mouthwash

Chlorhexidine mouthwash,10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.

Intervention Type DRUG

Other Intervention Names

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control Experimental Chlorhexidine mouthwash made by Perio-Kin, Livar CO. Spain

Eligibility Criteria

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Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Amirhossein Farahmand

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

Responsibility Role PRINCIPAL_INVESTIGATOR