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Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash

Primary Purpose

Gingivitis, Dental Plaque

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Myrrh mouthwash
Chlorhexidine mouthwash
Normal saline
Sponsored by
King Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring gingivitis, herbal, myrrh, myrrha, antigingivitis, antiplaque, IL-1, dental plaque

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • King Abdul Aziz University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Myrrh mouthwash

Chlorhexidine Mouthwash

Normal saline

Arm Description

1% mouthwash of Commiphora myrrha made from resin extract. Participants will use 10 ml of the mouthwash twice daily for 14 days.

Commercial 0.2% Chlorhexidine gluconate mouthwash (Avalon Pharma, Riyadh). Participants will use 10 ml of the mouthwash twice daily for 14 days.

Commercial 0.9% sodium chloride solution (Pharmaceutical solutions industry, Jeddah). Participants will use 10 ml of the mouthwash twice daily for 14 days.

Outcomes

Primary Outcome Measures

Change from Baseline in inflammation on the proinflammatory interleukin (IL)-1β biomarker at 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

Change from Baseline in gingivitis on the 4-point Modified Gingival Index (MGI) at Day 7 and 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)
Change from Baseline in plaque accumulation on O'leary Plaque Index (PI) at Day 7 and 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)
Change from Baseline in gingival bleeding on the Gingival Bleeding Index (GBI) at 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.

Full Information

First Posted
November 9, 2020
Last Updated
January 25, 2021
Sponsor
King Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT04723732
Brief Title
Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
December 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Dental Plaque
Keywords
gingivitis, herbal, myrrh, myrrha, antigingivitis, antiplaque, IL-1, dental plaque

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myrrh mouthwash
Arm Type
Experimental
Arm Description
1% mouthwash of Commiphora myrrha made from resin extract. Participants will use 10 ml of the mouthwash twice daily for 14 days.
Arm Title
Chlorhexidine Mouthwash
Arm Type
Active Comparator
Arm Description
Commercial 0.2% Chlorhexidine gluconate mouthwash (Avalon Pharma, Riyadh). Participants will use 10 ml of the mouthwash twice daily for 14 days.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Commercial 0.9% sodium chloride solution (Pharmaceutical solutions industry, Jeddah). Participants will use 10 ml of the mouthwash twice daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
Myrrh mouthwash
Other Intervention Name(s)
Commiphora myrrha mouthwash
Intervention Description
1% mouthwash solution of commiphora myrrha, made from Commiphora Myrrha resin extract.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Other Intervention Name(s)
Chlorhexidine gluconate mouthwash, Avalon Avohex mouthwash
Intervention Description
0.2% mouthwash solution of chlorhexidine gluconate.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Sodium Chloride solution
Intervention Description
0.9% solution of sodium chloride, containing 9 g/L Sodium Chloride (154 mEq/L sodium and 154 mEq/L chloride)
Primary Outcome Measure Information:
Title
Change from Baseline in inflammation on the proinflammatory interleukin (IL)-1β biomarker at Day 14
Description
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.
Time Frame
Baseline and Day 14
Secondary Outcome Measure Information:
Title
Change from Baseline in gingivitis on the 4-point Modified Gingival Index (MGI) at Day 7 and 14
Description
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)
Time Frame
Baseline, Day 7, and Day 14
Title
Change from Baseline in plaque accumulation on O'leary Plaque Index (PI) at Day 7 and 14
Description
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)
Time Frame
Baseline, Day 7, and Day 14
Title
Change from Baseline in gingival bleeding on the Gingival Bleeding Index (GBI) at Day 14
Description
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.
Time Frame
Baseline and Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talal Zahid, M.S
Organizational Affiliation
King Abdulaziz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Abdul Aziz University
City
Jeddah
State/Province
Makkah
ZIP/Postal Code
21589
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash

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