Comparative Clinical Effects of Salvadora Persica Oral Rinse And A Phenolic Commercial Mouth Wash On Human Oral Health

Plaque, Dental Clinical Trial

— RCT  

Official title:

Comparative Clinical Effects of Salvadora Persica Oral Rinse And A Phenolic Commercial Mouth Wash On Human Oral Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04713566
• Other study ID #: MMDC
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: January 2021
• Source: Multan Medical And Dental College
• Contact: Aeeza Malik, BDS, MDS
• Phone: +923089162634
• Email: aeezamalik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ABSTRACT:

OBJECTIVE: To compare the clinical effects of Salvadora persica (miswak) oral rinse and commercial Listerein mouth wash on oral health of socially deprived madrasa girls.

METHODS: Girls aged 18-22 years living permanently in a madrasa of Multan city will be recruited. Sample size and trial duration will be determined using the American Dental Association guidelines. Participants will be randomized into two interventional groups; A and B and will be either provided with Salvadora persica oral rinse and commercial Listerein mouth wash respectively. Pre, mid and post-intervention examinations will be executed by a blind and calibrated examiner using Turesky Quigley Hein Plaque and Loe and Silness Gingival indices. Statistical analysis will include descriptive statistics and two sample independent t-tests. The p-value of <0.05 will be considered significant at 95 % confidence level.

KEY WORDS: Dental plaque, Gingivitis, Miswak, Mouthwash

Description:

Comparative clinical effects of Salvadora persica (miswak) oral rinse and commercial Listerein mouth wash will be studied on the oral health of socially deprived madrasa girls. Girls aged 18-22 years living permanently in a madrasa of Multan city will be recruited. Sample size and trial duration will be determined using the American Dental Association guidelines. Participants will be randomized into two interventional groups; A and B and were either provided with Salvadora persica oral rinse and commercial Listerein mouth wash respectively. Pre, mid and post-intervention examinations will be executed by a blind and calibrated examiner using Turesky Quigley Hein Plaque and Loe and Silness Gingival indices. Statistical analysis will include descriptive statistics and two sample independent t-tests. The p-value of <0.05 will be considered significant at 95 % confidence level.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 30, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 25 Years

Eligibility

Exclusion Criteria:

• Participants/girls with any medical or dental disease,

• Participants/girls with any dental prosthesis,

• Those taken antibiotics in last 6 months,

• Those received any periodontal therapy in last 3 months

Inclusion Criteria:

*Participants with at least 10 sites of chronic mild gingivitis with bleeding on probing but not having periodontal pockets of greater than 3mm

Related Conditions & MeSH terms

• Dental Plaque
• Plaque, Dental

Intervention

Other:
• oral rinces
natural and commercial oral rinses were compared for efficacy

Locations

Country	Name	City	State
Pakistan	Aeeza Malik	Multan	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Multan Medical And Dental College

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plaque and gingivitis scores	Dental examination will be conducted at baseline, then after 3 and 6 months, that is, Pre-Interventional, Mid Intervention and Post-Interventional phases respectively. It will be executed on inclined chairs in day light using a sterilized dental mirror and CPITN (Community Periodontal Index of Treatment Need) probe. This probe has a ball ended tip with a diameter of 0.5mm. This probe have two coloured bands of 2mm graduations each, one at 3.5 to 5.5mm and second at 8.5 to 11.5mm. These bands determine the bleeding on probing which correspond to respective gingival score as per Loe and Silness Gingival index (1962)	6 months