- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07401069
Homemade Herbal Mouthwash in Gingivitis. A Randomized Clinical Trial.
The Effect of Homemade Herbal Mouthwash Versus Chlorhexidine on Plaque Accumulation in Gingivitis. A Randomized Clinical Trial.
Gingivitis is a very common oral disease that may progress to the more destructive periodontitis if not treated. As oral plaque is a key player in gingivitis, plaque control by professional scaling and oral hygiene measures represents the main line of treatment.
Among the oral hygiene measures, using chlorhexidine mouthwash is considered the gold standard in mouthwashes. However, due to its side effects, a safer and more acceptable mouthwash is needed. Therefore, this study proposes mouthwashes made of infusion of natural herbs as an alternative.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Plaque-induced gingivitis.
Exclusion Criteria:
- Medically compromised.
- History of medications.
- Pregnant females.
- Periapical involvement in teeth.
- History of periodontal surgery.
- If gingivitis was due to local factor.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Chlorhexidine mouthwash
|
chlorhexidine 0.12% mouthwash twice daily for 7 days
|
|
Experimental: Herbal Homemade Mouthwash
|
Mouthwash made at home by boiling herbs in water and then saving the solution in a tightly closed container for daily use for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
plaque index (O'Leary et al., 1972)
Time Frame: 7 days
|
Plaque accumulation is tested on teeth with a probe.
Number of sites having plaque accumulation will be divided by the total number of dental sites to get percentage of plaque accumulation.
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bleeding on probing
Time Frame: 7 days
|
Bleeding on probing is tested on teeth with a periodontal probe.
Number of sites showing bleeding will be divided by the total number of dental sites to get percentage of bleeding on probing.
|
7 days
|
|
Changes in clinical signs of inflammation (Armitage, 2004)
Time Frame: 7 days
|
Results will be in the form of (Yes/No); indicating if the gingival clinical condition (color and contour) was improved or not
|
7 days
|
|
Bleeding on brushing
Time Frame: 7 days
|
Evaluation of extent of daily bleeding on brushing using VAS.
|
7 days
|
|
Patient's acceptance of the mouthwash
Time Frame: 7 days
|
questionnaire
|
7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACU-Per3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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