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

NCT04713566 | Unknown

• 1 other identifier: MMDC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Plaque, Dental

Keywords

Dental plaque; Gingivitis; Miswak; Mouthwash

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

will be using Salvadora Persica oral rinse

Other: oral rinces

Group B

EXPERIMENTAL

will be using Commercial Phenolic mouthwash.

Other: oral rinces

Interventions

oral rinces OTHER

natural and commercial oral rinses were compared for efficacy

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

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

Sponsors & Collaborators

• Multan Medical And Dental College: lead

Study Sites (1)

Aeeza Malik

Multan Khurd, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Aeeza Malik, BDS, MDS

  Multan Medical & Dental College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aeeza Malik, BDS, MDS

CONTACT

+923089162634; aeezamalik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 19, 2021
• Study Start: March 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: September 30, 2021
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)