Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash

Sponsor

King Abdulaziz University (Other)

Overall Status

Completed

CT.gov ID

NCT04723732

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gingivitis Dental Plaque	Drug: Myrrh mouthwash Drug: Chlorhexidine mouthwash Drug: Normal saline	N/A

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 Design

Study Type:

Interventional

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 :

Aug 15, 2017

Actual Primary Completion Date :

Aug 15, 2018

Actual Study Completion Date :

Dec 15, 2018

Arms and Interventions

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 Names: 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 Names: Sodium Chloride solution

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 Names:

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 Names:

Sodium Chloride solution

Outcome Measures

Primary Outcome Measures

Change from Baseline in inflammation on the proinflammatory interleukin (IL)-1β biomarker at Day 14 [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

Change from Baseline in gingivitis on the 4-point Modified Gingival Index (MGI) at Day 7 and 14 [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)
Change from Baseline in plaque accumulation on O'leary Plaque Index (PI) at Day 7 and 14 [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)
Change from Baseline in gingival bleeding on the Gingival Bleeding Index (GBI) at Day 14 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.