- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04723732
Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash
January 25, 2021 updated by: talal zahid, King Abdulaziz University
A Clinical Study Comparing the Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash With Chlorhexidine Mouthwash in a 14-Day Experimental Gingivitis Model
Myrrh-based mouthwash has the potential to be a suitable alternative to the gold standard chlorhexidine mouthwash for dental plaque and gingivitis reduction.
To date, however, little research has been carried out to determine its true clinical significance on periodontal health.
The purpose of this study is to evaluate and compare the efficacy of 1% myrrh mouthwash with commercially available 0.2% chlorhexidine mouthwash in terms of plaque and gingivitis reduction and inflammatory mediator (interleukin-1β) inhibition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This will be a single-center, triple-blinded, randomized, three-arm parallel, controlled trial in periodontally healthy adult volunteers (no clinical attachment loss and bleeding on probing < 10%).
We will include all eligible patients seeking dental treatment at the center after gaining a written informed consent.
After the initial dental screening and a session of professional teeth cleaning procedures, participants will be instructed to refrain from regular oral hygiene practices for 2 weeks to develop experimental gingivitis.
Participants will then be randomly allocated to one of the three treatment groups [1:1:1] using a simple randomization method (i.e.
computer-generated random numbers).
They will be instructed to continue refrain from regular oral hygiene practices and use 10 ml of the assigned mouthwash twice daily for 1 minute.
Treatment effect will be evaluated by comparing the baseline (day 0) and post-intervention (day 14) values of all clinical parameters (modified gingival index, plaque index, proinflammatory interleukin-1β biomarker, and Gingival Bleeding Index).
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Makkah
-
Jeddah, Makkah, Saudi Arabia, 21589
- King Abdul Aziz University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- good periodontal health;
- dentition of ≥20 teeth and a minimum of 5 teeth per quadrant;
- the absence of any systemic illness;
- no history of oral prophylaxis in the past 6 months;
- no relevant medical history that might compromise normal oral hygiene practice.
Exclusion Criteria:
- pocket depth >3 mm
- severe misalignment of teeth;
- the presence of orthodontic appliances;
- intake of antibiotic and/or anti-inflammatory medications within the past 6 months;
- use of tobacco;
- inability of comply with the study's appointment schedule;
- pregnant or breast-feeding mothers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Myrrh mouthwash
1% mouthwash of Commiphora myrrha made from resin extract.
Participants will use 10 ml of the mouthwash twice daily for 14 days.
|
1% mouthwash solution of commiphora myrrha, made from Commiphora Myrrha resin extract.
Other Names:
|
Active Comparator: Chlorhexidine Mouthwash
Commercial 0.2% Chlorhexidine gluconate mouthwash (Avalon Pharma, Riyadh).
Participants will use 10 ml of the mouthwash twice daily for 14 days.
|
0.2% mouthwash solution of chlorhexidine gluconate.
Other Names:
|
Placebo Comparator: Normal saline
Commercial 0.9% sodium chloride solution (Pharmaceutical solutions industry, Jeddah).
Participants will use 10 ml of the mouthwash twice daily for 14 days.
|
0.9% solution of sodium chloride, containing 9 g/L Sodium Chloride (154 mEq/L sodium and 154 mEq/L chloride)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in inflammation on the proinflammatory interleukin (IL)-1β biomarker at Day 14
Time Frame: Baseline and Day 14
|
IL-1β is an important mediator of the inflammatory response.
Elevated IL-1β levels have been reported in a number of infectious disease conditions and in noninfectious inflammatory conditions.
Human IL-1β ELISA kit by BioVendor was utilized to determine the IL-1β level.
Preparation of reagents, execution of test protocol, and calculation of results were done adhering to the manufacturer's Product Data Sheet enclosed with the kit.
The absorbance of each strip was read on a spectro-photometer at 450 nm wave length.
|
Baseline and Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in gingivitis on the 4-point Modified Gingival Index (MGI) at Day 7 and 14
Time Frame: Baseline, Day 7, and Day 14
|
The MGI is a noninvasive visual assessment tool to assess the severity of gingivitis over time.
It uses a rating score between 0 (normal gingiva) and 3 (severe inflammation with tendency to spontaneous bleeding).
Change = (Day 14 Score - Baseline Score)
|
Baseline, Day 7, and Day 14
|
Change from Baseline in plaque accumulation on O'leary Plaque Index (PI) at Day 7 and 14
Time Frame: Baseline, Day 7, and Day 14
|
The PI is a validated assessment tool based on recording of the presence of soft debris and mineralized deposits on all 4 surfaces of all teeth.
It uses a rating score between 0 (no plaque) and 1 (plaque present at gingival margin).
Change = (Day 14 Score - Baseline Score)
|
Baseline, Day 7, and Day 14
|
Change from Baseline in gingival bleeding on the Gingival Bleeding Index (GBI) at Day 14
Time Frame: Baseline and Day 14
|
The GBI is a reliable indicator of gingival inflammation and periodontal stability.
It uses gentle probing of the orifice of the gingival sulcus.
The bleeding on probing (BOP) was assessed using a standardized periodontal probe with a 0.6 mm tip and 1 mm marking.
A trained examiner measured BOP applying probing forces not exceeding 0.25 N (25 g).
A positive finding was recorded if bleeding occured within 10 seconds.
|
Baseline and Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Talal Zahid, M.S, King Abdulaziz University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2017
Primary Completion (Actual)
August 15, 2018
Study Completion (Actual)
December 15, 2018
Study Registration Dates
First Submitted
November 9, 2020
First Submitted That Met QC Criteria
January 25, 2021
First Posted (Actual)
January 26, 2021
Study Record Updates
Last Update Posted (Actual)
January 26, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 058-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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