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Completed

NCT Number: NCT04723732

Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdul Aziz University

Jeddah, Mecca Region, 21589, Saudi Arabia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Myrrh mouthwash

Drug

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

Other names: Commiphora myrrha mouthwash

Chlorhexidine mouthwash

Drug

0.2% mouthwash solution of chlorhexidine gluconate.

Other names: Chlorhexidine gluconate mouthwash, Avalon Avohex 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)

Other names: Sodium Chloride solution

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2021
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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