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Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04723732
Recruitment Status : Completed
First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
talal zahid, King Abdulaziz University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gingivitis Dental Plaque Drug: Myrrh mouthwash Drug: Chlorhexidine mouthwash Drug: Normal saline Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Study Comparing the Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash With Chlorhexidine Mouthwash in a 14-Day Experimental Gingivitis Model
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : December 15, 2018


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.
Drug: Myrrh mouthwash
1% mouthwash solution of commiphora myrrha, made from Commiphora Myrrha resin extract.
Other Name: Commiphora myrrha mouthwash

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.
Drug: Chlorhexidine mouthwash
0.2% mouthwash solution of chlorhexidine gluconate.
Other Names:
  • Chlorhexidine gluconate mouthwash
  • Avalon Avohex mouthwash

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.
Drug: Normal saline
0.9% solution of sodium chloride, containing 9 g/L Sodium Chloride (154 mEq/L sodium and 154 mEq/L chloride)
Other Name: Sodium Chloride solution




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723732


Locations
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Saudi Arabia
King Abdul Aziz University
Jeddah, Makkah, Saudi Arabia, 21589
Sponsors and Collaborators
King Abdulaziz University
Investigators
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Principal Investigator: Talal Zahid, M.S King Abdulaziz University
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Responsible Party: talal zahid, Associate Professor, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT04723732    
Other Study ID Numbers: 058-15
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by talal zahid, King Abdulaziz University:
gingivitis
herbal
myrrh
myrrha
antigingivitis
antiplaque
IL-1
dental plaque
Additional relevant MeSH terms:
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Gingivitis
Dental Plaque
Infections
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents