An interventional study of Myrrh mouthwash and Chlorhexidine mouthwash in Gingivitis and Dental Plaque, sponsored by King Abdulaziz University. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by King Abdulaziz University · Not applicable, Interventional, and Treatment
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.
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).
590 studies on the registry are indexed under Gingivitis; 105 are open to participants now.
This study's enrollment of 24 is below the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →King Abdulaziz University is the lead sponsor of 96 studies on the registry; 18 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
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
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
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
1% mouthwash solution of commiphora myrrha, made from Commiphora Myrrha resin extract.
Also known as: Commiphora myrrha mouthwash
0.2% mouthwash solution of chlorhexidine gluconate.
Also known as: Chlorhexidine gluconate mouthwash, Avalon Avohex mouthwash
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
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.
Time frame: Baseline and Day 14
Change from Baseline in gingivitis on the 4-point Modified Gingival Index (MGI) at Day 7 and 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)
Time frame: Baseline, Day 7, and Day 14
Change from Baseline in plaque accumulation on O'leary Plaque Index (PI) at Day 7 and 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)
Time frame: Baseline, Day 7, and Day 14
Change from Baseline in gingival bleeding on the Gingival Bleeding Index (GBI) at 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.
Time frame: Baseline and Day 14
Plan to share: No
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King Abdulaziz University