Periodontal DiseasesPhase 2/3NCT02756377
A Comparison of Mouth Rinse Containing Alcohol-free Chlorhexidine With a Cetylpyridinium Chloride in Periodontal Diseases
A Phase 2/3 study testing cetylpyridinium chloride mouthwash and Chlorhexidine mouthwash in people with Periodontal Diseases, run by Islamic Azad University, Sanandaj.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- cetylpyridinium chloride mouthwash and Chlorhexidine mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jun 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
About this study
Official title: A Comparison of Mouth Rinse Containing Alcohol-free Chlorhexidine With a Cetylpyridinium Chloride in Periodontal Diseases (A Randomized, Double-blind Clinical Trials)
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 .
- Conditions
- Periodontal Diseases
- Being tested
- cetylpyridinium chloride mouthwash, Chlorhexidine mouthwash
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetylpyridinium chloride mouthwashDrug
Also called control
cetylpyridinium chloride mouthwash, 10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
Chlorhexidine mouthwashDrug
Also called Experimental Chlorhexidine mouthwash made by Perio-Kin, Livar CO. Spain
Chlorhexidine mouthwash,10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: cetylpyridinium chloride mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of bleeding on probing
Periodontal pobe
Measured: 7 days
Secondary outcomes (2)
Reduction of plaque index
Plaque Index (O'Leary)
Measured: 7 days
Reduction of pocket depth
Periodontal pobe
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startMay 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amirhossein Farahmand, Islamic Azad University, Sanandaj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756377
- Sponsor's protocol ID
- 483
- Status last verified
- Apr 2016
- First submitted
- 27 Apr 2016
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Mouth Rinse Containing Alcohol-free Chlorhexidine With a Cetylpyridinium Chloride in Periodontal Diseases (A Randomized, Double-blind Clinical Trials)
- ClinicalTrials.gov ID
- NCT02756377
- Acronym / sponsor ID
- 483
- Conditions
- Periodontal Diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cetylpyridinium chloride | Active comparator | Drug: cetylpyridinium chloride mouthwash, Drug: Chlorhexidine mouthwashmouthwash (cetylpyridinium chloride)10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks. |
| Chlorhexidine mouthwash | Active comparator | Drug: cetylpyridinium chloride mouthwashmouthwash ( Alcohol-free chlorhexidine)10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cetylpyridinium chloride mouthwashAlso: controlcetylpyridinium chloride mouthwash, 10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks. | Drug | Chlorhexidine mouthwash, cetylpyridinium chloride |
| Chlorhexidine mouthwashAlso: Experimental Chlorhexidine mouthwash made by Perio-Kin, Livar CO. SpainChlorhexidine mouthwash,10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks. | Drug | cetylpyridinium chloride |
Primary outcome
Reduction of bleeding on probing
Time frame: 7 days
Periodontal pobe
2 secondary outcomes
Reduction of plaque index
Time frame: 7 days
Reduction of pocket depth
Time frame: 7days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing cetylpyridinium chloride mouthwash and Chlorhexidine mouthwash in people with Periodontal Diseases, run by Islamic Azad University, Sanandaj.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of bleeding on probing (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.