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

Sponsor

Multan Medical And Dental College (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04713566

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Plaque, Dental	Other: oral rinces	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A will be using Salvadora Persica oral rinse	Other: oral rinces natural and commercial oral rinses were compared for efficacy
Experimental: Group B will be using Commercial Phenolic mouthwash.	Other: oral rinces natural and commercial oral rinses were compared for efficacy

Arm

Intervention/Treatment

Experimental: Group A

will be using Salvadora Persica oral rinse

Other: oral rinces

natural and commercial oral rinses were compared for efficacy

Experimental: Group B

will be using Commercial Phenolic mouthwash.

Other: oral rinces

natural and commercial oral rinses were compared for efficacy

Outcome Measures

Primary Outcome Measures

plaque and gingivitis scores [6 months]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aeeza Malik	Multān	Punjab	Pakistan	66000

Sponsors and Collaborators

Multan Medical And Dental College

Investigators

Principal Investigator: Aeeza Malik, BDS, MDS, Multan Medical & Dental College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Aeeza Malik, Associate Professor, Multan Medical And Dental College

ClinicalTrials.gov Identifier:

NCT04713566

Other Study ID Numbers:

MMDC

First Posted:

Jan 19, 2021

Last Update Posted:

Jan 19, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Aeeza Malik, Associate Professor, Multan Medical And Dental College

Additional relevant MeSH terms:

Dental Plaque

Study Results

No Results Posted as of Jan 19, 2021