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Status unknownNCT04713566RCTUpdated Jan 19, 2021

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

An interventional study of oral rinces in Plaque, Dental, sponsored by Multan Medical And Dental College. Status unknown at 1 site in Pakistan. Open to female participants aged 20 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-19.

Sponsored by Multan Medical And Dental College · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 25 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Plaque, Dental

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Keywords

  • Dental plaque
  • Gingivitis
  • Miswak
  • Mouthwash
03

In context

Dental Plaque

314 studies on the registry are indexed under Dental Plaque; 54 are open to participants now.

This study's planned enrollment of 60 is close to the median of 59 across 279 interventional studies indexed under Dental Plaque.

Browse Dental Plaque studies →

Lead sponsor

Multan Medical And Dental College is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 25 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group A

    will be using Salvadora Persica oral rinse

    Other: oral rinces

  • Experimental
    Group B

    will be using Commercial Phenolic mouthwash.

    Other: oral rinces

Interventions

  • Otheroral rinces

    natural and commercial oral rinses were compared for efficacy

06

What researchers measure

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)

    Time frame: 6 months

07

Study locations

1 site
  • Aeeza Malik
    Multān, Punjab 66000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04713566
Lead sponsor
Multan Medical And Dental College
Responsible party
Dr. Aeeza Malik (Associate Professor, Multan Medical And Dental College) — Principal investigator
First posted
Jan 19, 2021
Start date
Mar 1, 2021 (estimated)
Primary completion
Aug 1, 2021 (estimated)
Completion
Sep 30, 2021 (estimated)
Last update
Jan 19, 2021

Study contacts

Aeeza Malik, BDS, MDS
Contact
aeezamalik@gmail.com
+923089162634
Aeeza Malik, BDS, MDS
principal investigator · Multan Medical & Dental College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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