GingivitisPhase 4NCT02154594
"The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.
A Phase 4 study testing Acacia catechu, Chlorhexidine gluconate and Distilled water in people with Gingivitis, run by Tatyasaheb Kore Dental College at 1 site in India.
Trial summary
To study effect of acacia catechu a herbal extract;as antipaque and antigingivitis agent in patients with fixed orthodontic appliances.This study is a double blind randomized controlled trial. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Acacia catechu, Chlorhexidine gluconate and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2014to Mar 2014
- Phase
- Phase 4
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 60 patients in the age group of 15-30 yrs
- plaque induced gingivitis having fixed orthodontic appliance
Who cannot join
- seeking any type of antibacterial mouthwash within four weeks of commencement of study,
- history of any systemic disease, or past illness,
- mentally or physically handicapped,
- history of smoking, tobacco chewing, alcohol consumption,
- patients with periodontitis, pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
India1 site
Tatyasaheb Kore Dental College and Research Centre
Kolhāpur, Maharashtra, 416 137
About this study
To study effect of acacia catechu a herbal extract;as antipaque and antigingivitis agent in patients with fixed orthodontic appliances.This study is a double blind randomized controlled trial.
- Conditions
- Gingivitis
- Being tested
- Acacia catechu, Chlorhexidine gluconate, Distilled water
- Keywords
- Acacia, Chlorhexidine, Gingivitis, Orthodontic appliances.
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acacia catechuDrug
Chlorhexidine gluconateDrug
Also called Hexidine
Distilled waterOther
| Study group | Role | What they receive |
|---|---|---|
| Acacia | Experimental | Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days Receives: Drug: Acacia catechu; Drug: Chlorhexidine gluconate; Other: Distilled water |
| Chlorhexidine gluconate | Active comparator | Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days Receives: Drug: Acacia catechu; Drug: Chlorhexidine gluconate; Other: Distilled water |
| Distilled water | Placebo comparator | Rinse with 10 ml distilled water twice daily for 15 days. Receives: Drug: Acacia catechu; Drug: Chlorhexidine gluconate; Other: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Plaque index(PI)
Measured: 15 Days
Secondary outcomes (1)
Changes from baseline in Gingival index(GI)
Measured: 15 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatyasaheb Kore Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.DHANASHREE RAVINDRA AGARWAL, Tatyasaheb Kore Dental College
- Investigators
- Dr.Dhanashree R. Agarwal, B.D.S., Principal investigator, Tatyasaheb Kore Dental College and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154594
- Sponsor's protocol ID
- DHANASHREE289
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.
- ClinicalTrials.gov ID
- NCT02154594
- Acronym / sponsor ID
- DHANASHREE289
- Conditions
- Gingivitis
- Keywords
- Acacia, Chlorhexidine, Gingivitis, Orthodontic appliances.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tatyasaheb Kore Dental CollegeUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Jun 2014 (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.
To study effect of acacia catechu a herbal extract;as antipaque and antigingivitis agent in patients with fixed orthodontic appliances.This study is a double blind randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acacia | Experimental | Drug: Acacia catechu, Drug: Chlorhexidine gluconate, Other: Distilled waterRinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days |
| Chlorhexidine gluconate | Active comparator | Drug: Acacia catechu, Drug: Chlorhexidine gluconate, Other: Distilled waterRinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days |
| Distilled water | Placebo comparator | Drug: Acacia catechu, Drug: Chlorhexidine gluconate, Other: Distilled waterRinse with 10 ml distilled water twice daily for 15 days. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 60 patients in the age group of 15-30 yrs
- plaque induced gingivitis having fixed orthodontic appliance
Key exclusion criteria (5 listed)
- seeking any type of antibacterial mouthwash within four weeks of commencement of study,
- history of any systemic disease, or past illness,
- mentally or physically handicapped,
- history of smoking, tobacco chewing, alcohol consumption,
- patients with periodontitis, pregnant and lactating women
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 |
|---|---|---|
| Acacia catechu | Drug | Acacia, Chlorhexidine gluconate, Distilled water |
| Chlorhexidine gluconateAlso: Hexidine | Drug | Acacia, Chlorhexidine gluconate, Distilled water |
| Distilled water | Other | Acacia, Chlorhexidine gluconate, Distilled water |
Primary outcome
Changes from baseline in Plaque index(PI)
Time frame: 15 Days
1 secondary outcome
Changes from baseline in Gingival index(GI)
Time frame: 15 Days
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 3 Jun 2014.
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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.
Dr.Dhanashree R. Agarwal, B.D.S. principal investigator
Tatyasaheb Kore Dental College and Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acacia catechu, Chlorhexidine gluconate and Distilled water in people with Gingivitis, run by Tatyasaheb Kore Dental College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. 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 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Changes from baseline in Plaque index(PI) (time frame: 15 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 3 Jun 2014.