Clinical trial NCT04723732: Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Dental Plaque
Keywords: gingivitis
herbal
myrrh
myrrha
antigingivitis
antiplaque
IL-1
dental plaque
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change from Baseline in inflammation on the proinflammatory interleukin (IL)-1β biomarker at Day 14
timeFrame: Baseline and Day 14
Secondary outcomes:
measure: Change from Baseline in gingivitis on the 4-point Modified Gingival Index (MGI) at Day 7 and 14
timeFrame: Baseline, Day 7, and Day 14
measure: Change from Baseline in plaque accumulation on O'leary Plaque Index (PI) at Day 7 and 14
timeFrame: Baseline, Day 7, and Day 14
measure: Change from Baseline in gingival bleeding on the Gingival Bleeding Index (GBI) at Day 14
timeFrame: Baseline and Day 14
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdul Aziz University
state: Makkah
Study officials:
affiliation: King Abdulaziz University
name: Talal Zahid, M.S
role: PRINCIPAL_INVESTIGATOR
References: