Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash

NCT04723732 | Completed

• 1 other identifier: 058-15
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Dental Plaque

Keywords

gingivitis; herbal; myrrh; myrrha; antigingivitis; antiplaque; IL-1; dental plaque

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Day 14

Secondary Outcomes (3)

• Change from Baseline in gingivitis on the 4-point Modified Gingival Index (MGI) at Day 7 and 14

  Baseline, Day 7, and Day 14

• Change from Baseline in plaque accumulation on O'leary Plaque Index (PI) at Day 7 and 14

  Baseline, Day 7, and Day 14

• Change from Baseline in gingival bleeding on the Gingival Bleeding Index (GBI) at Day 14

  Baseline and Day 14

Study Arms (3)

Myrrh mouthwash

EXPERIMENTAL

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

Chlorhexidine Mouthwash

ACTIVE COMPARATOR

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

Normal saline

PLACEBO COMPARATOR

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

Interventions

Myrrh mouthwash DRUG

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

Also known as: Commiphora myrrha mouthwash

Myrrh mouthwash

Chlorhexidine mouthwash DRUG

0.2% mouthwash solution of chlorhexidine gluconate.

Also known as: Chlorhexidine gluconate mouthwash, Avalon Avohex mouthwash

Chlorhexidine Mouthwash

Normal saline DRUG

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

Also known as: Sodium Chloride solution

Normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdul Aziz University

Jeddah, Mecca Region, 21589, Saudi Arabia

Location

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Talal Zahid, M.S

  King Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: January 26, 2021
• Study Start: August 15, 2017
• Primary Completion: August 15, 2018
• Study Completion: December 15, 2018
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)