Clinical trial NCT04713566: Comparative Clinical Effects of Salvadora Persica Oral Rinse And A Phenolic Commercial Mouth Wash On Human Oral Health
Official title: Comparative Clinical Effects of Salvadora Persica Oral Rinse And A Phenolic Commercial Mouth Wash On Human Oral Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plaque, Dental
Keywords: Dental plaque
Gingivitis
Miswak
Mouthwash
Lead sponsor: Multan Medical And Dental College
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: plaque and gingivitis scores
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Multān
country: Pakistan
facility: Aeeza Malik
state: Punjab
Study officials:
affiliation: Multan Medical & Dental College
name: Aeeza Malik, BDS, MDS
role: PRINCIPAL_INVESTIGATOR
References: