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

NCT02756377 | Completed Phase 2 DMC

• 1 other identifier: 483
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• Reduction of bleeding on probing

  Periodontal pobe

  7 days

Secondary Outcomes (2)

• Reduction of plaque index

  7 days

• Reduction of pocket depth

  7days

Study Arms (2)

cetylpyridinium chloride

ACTIVE COMPARATOR

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

Drug: cetylpyridinium chloride mouthwash; Drug: Chlorhexidine mouthwash

Chlorhexidine mouthwash

ACTIVE COMPARATOR

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

Drug: cetylpyridinium chloride mouthwash

Interventions

cetylpyridinium chloride mouthwash DRUG

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

Also known as: control

Chlorhexidine mouthwash; cetylpyridinium chloride

Chlorhexidine mouthwash DRUG

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

Also known as: Experimental Chlorhexidine mouthwash made by Perio-Kin, Livar CO. Spain

cetylpyridinium chloride

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

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

Sponsors & Collaborators

• Islamic Azad University, Sanandaj: lead

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical effectiveness of 0.05% cetylpyridinium chloride mouth rinse in patients with gingivitis as compared to non-alcoholic chlorhexidine mouth wash

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: April 29, 2016
• Study Start: May 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 2, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share