Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash

King Abdulaziz University

Status: Completed

Conditions: Dental Plaque; Gingivitis

Treatments: Drug: Chlorhexidine mouthwash; Drug: Normal saline; Drug: Myrrh mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT04723732

058-15

Details and patient eligibility

About

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.

Full 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).

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

Myrrh mouthwash

Experimental group

Description:

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

Treatment:

Drug: Myrrh mouthwash

Chlorhexidine Mouthwash

Active Comparator group

Description:

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

Treatment:

Drug: Chlorhexidine mouthwash

Normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline