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CompletedNCT02756377Updated May 2, 2016

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

A Phase 2/3 interventional study of cetylpyridinium chloride mouthwash and Chlorhexidine mouthwash in Periodontal Diseases, sponsored by Islamic Azad University, Sanandaj. Completed. Open to participants aged 18 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-02.

Sponsored by Islamic Azad University, Sanandaj · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 34 Years
Sex
All
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Study 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.

Read the 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 .

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Conditions studied

  • Periodontal Diseases

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03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 34 is below the median of 45 across 530 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Islamic Azad University, Sanandaj is the lead sponsor of 26 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 34 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    cetylpyridinium chloride

    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

  • Active comparator
    Chlorhexidine mouthwash

    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

  • Drugcetylpyridinium chloride mouthwash

    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

  • DrugChlorhexidine mouthwash

    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

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What researchers measure

Primary outcomes

  1. Reduction of bleeding on probing

    Periodontal pobe

    Time frame: 7 days

Secondary outcomes

  1. Reduction of plaque index

    Plaque Index (O'Leary)

    Time frame: 7 days

  2. Reduction of pocket depth

    Periodontal pobe

    Time frame: 7days

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02756377
Lead sponsor
Islamic Azad University, Sanandaj
Responsible party
Amirhossein Farahmand (clinical effectiveness of 0.05% cetylpyridinium chloride mouth rinse in patients with gingivitis as compared to non-alcoholic chlorhexidine mouth wash, Islamic Azad University, Sanandaj) — Principal investigator
First posted
Apr 29, 2016
Start date
May 2014
Primary completion
Apr 2015
Completion
Jun 2015
Last update
May 2, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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