Role of Herbal Dentifrices in the Management of Plaque In... | NCT04830176

Studies
Role of Herbal Dentifrices in the Management of Plaque Induced Gingivitis

NCT04830176

Sponsor

Ajman University

Status

Completed

Last Update Posted

Apr 8, 2021Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Gingiva; Infection
Plaque, Dental

Interventions

dentifrice

Countries

India

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2021Actual

Primary Completion Date

Mar 20, 2021Actual

Completion Date

Mar 28, 2021Actual

First Submitted Date

Apr 1, 2021

First Submission Date that Met QC Criteria

Apr 1, 2021

First Posted Date

Apr 5, 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

Apr 6, 2021

Last Update Posted Date

Apr 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

sudhir rama varma, Clinical Assistant Professor, Ajman UniversityPrincipal Investigator

Lead Sponsor

Ajman UniversityOTHER

Collaborators

Name	Class
A B Shetty Memorial Institute of Dental Science	OTHER

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

The clinical cross over study involves the use of two herbal based dentifirices moringa and miswak and its efficacy in reducing plaque induced gingivitis. The patients selected are provided with details regarding the research format and consent taken.

Detailed Description

The clinical cross over study involves use of miswak and moringa dentifrices. The patients selected are 30 in no and are selected based on having gingival inflammation due to plaque accumulation. All other cases related to gingival inflammation along with patients with underlying systemic disease are excluded from the study.

At baseline, plaque and gingival scores are recorded, followed by giving one of the dentifrice to the patient for brushing. The patients are asked to brush twice a day and asked to report after 72 hrs, following which another recording of plaque and gingival scores are recorded.

The patients are then asked to use their own tooth paste for a period of 2 weeks as a wash out period and recalled after this 2 week interval.

The patients are then given the second dentifrice and asked to brush for 72 hrs and then asked to report again for a plaque and gingival score evaluation.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
moringa	Active Comparator	First phase of subjects were given dentifrice for brushing	Other: dentifrice
miswak	Active Comparator	second phase of subjects were given dentifrice for brushing	Other: dentifrice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dentifrice	Other	use of dentifrices for brushing	miswak moringa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
plaque scores	plaque score recorded using calibrated periodontal probes	72 hours

Secondary Outcomes

Measure	Description	Time Frame
Gingival inflammation scores	Gingival bleeding scores recorded using caliberated periodontal probes	72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects having only plaque induced gingival inflammation

Exclusion Criteria:

Subjects having gingival inflammation related to underling systemic diseases
Subjects taking medications
Gingival inflammation related to other causes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AB shetty Institute of dental sciences		Mangaluru			India

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The results of this study will be shared to other researchers

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Data can be accessible in a months time. The data will have unrestricted time frame

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D003773	Dental Plaque
D058225	Plaque, Amyloid
D005884	Gingival Hemorrhage

Ancestor Terms

ID	Term
D003741	Dental Deposits
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D020763	Pathological Conditions, Anatomical

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003802	Dentifrices

Ancestor Terms

ID	Term
D001697	Biomedical and Dental Materials
D003358	Cosmetics
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

sample size of 30- First group of 15 subjects recording of plaque and gingival scores were recorded. Patients were given first dentifrice and asked to brush for 72 hours and then asked to report. A washout period of 2 weeks followed. The next round, the subjects were given the second dentifrice and asked to brush for 72 hrs and then after a period of 3days asked to report

Masking Info

Masking

Double

Masking Description

Both the participant and the care provider were masked. They were unaware of the paste they were using as it was marked alphanumerically

Who Masked

ParticipantCare Provider