Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash

NCT ID: NCT04723732

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2018-12-15

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).

Conditions

Gingivitis; Dental Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Myrrh mouthwash

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

Group Type: EXPERIMENTAL

Myrrh mouthwash

Intervention Type: DRUG

1% mouthwash solution of commiphora myrrha, made from Commiphora Myrrha resin extract.

Chlorhexidine Mouthwash

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

Group Type: ACTIVE_COMPARATOR

Chlorhexidine mouthwash

Intervention Type: DRUG

0.2% mouthwash solution of chlorhexidine gluconate.

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

0.9% solution of sodium chloride, containing 9 g/L Sodium Chloride (154 mEq/L sodium and 154 mEq/L chloride)

Interventions

Myrrh mouthwash

1% mouthwash solution of commiphora myrrha, made from Commiphora Myrrha resin extract.

Intervention Type: DRUG

Chlorhexidine mouthwash

0.2% mouthwash solution of chlorhexidine gluconate.

Intervention Type: DRUG

Normal saline

0.9% solution of sodium chloride, containing 9 g/L Sodium Chloride (154 mEq/L sodium and 154 mEq/L chloride)

Intervention Type: DRUG

Other Intervention Names

Commiphora myrrha mouthwash; Chlorhexidine gluconate mouthwash; Avalon Avohex mouthwash; Sodium Chloride solution

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

talal zahid

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Talal Zahid, M.S

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz University

Locations

King Abdul Aziz University

Jeddah, Mecca Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

058-15

Identifier Type: -

Identifier Source: org_study_id