Comparative Clinical Effects of Salvadora Persica Oral Ri... | NCT04713566

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

NCT04713566

Sponsor

Multan Medical And Dental College

Status

Unknown status

Last Update Posted

Jan 19, 2021Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Plaque, Dental

Interventions

oral rinces

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Estimated

Primary Completion Date

Aug 1, 2021Estimated

Completion Date

Sep 30, 2021Estimated

First Submitted Date

Jan 11, 2021

First Submission Date that Met QC Criteria

Jan 14, 2021

First Posted Date

Jan 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2021

Last Update Posted Date

Jan 19, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Aeeza Malik, Associate Professor, Multan Medical And Dental CollegePrincipal Investigator

Lead Sponsor

Multan Medical And Dental CollegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
oral rinces	Other	natural and commercial oral rinses were compared for efficacy	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aeeza Malik, BDS, MDS	Contact	+923089162634		aeezamalik@gmail.com

Overall Officials

Name	Affiliation	Role
Aeeza Malik, BDS, MDS	Multan Medical & Dental College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aeeza Malik		Multan Khurd	Punjab Province	66000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003773	Dental Plaque
D005891	Gingivitis

Ancestor Terms

ID	Term
D003741	Dental Deposits
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided