Trials Sponsors Conditions Drugs Pricing

Conditions

Gingivitis PCOS

Outcome Measures

Primary Outcomes (2)

Bleeding on probing (BOP)
BOP will recorded as 1 (present) if it occurred within 15 sec of probing and 0 (absent) if no bleeding occurred. It will be calculated in %. After adding all the scores, total score will be divided by the total no. of surfaces accessed and multiplied by 100. It will be designed as % sites with bleeding on probing.
6 months
Serum high sensitivity C reactive protein (hsCRP) levels
Venous blood from the antecubital vein will be collected after applying a tourniquet in plain tubes without additive. Serum hsCRP levels will be assessed using a kit with high sensitivity methodology in an auto-analyzer according to the manufacturer's instructions. The test principle will be particle-enhanced immune-turbidimetric assay,in which human CRP agglutinates with the latex particles coated with monoclonal anti-CRP antibodies.
6 months

Study Arms (3)

Test group 1

EXPERIMENTAL

patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive scaling and oral hygiene instructions (OHI)

Procedure: scaling and OHI

Test group 2

EXPERIMENTAL

patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only

Procedure: oral Hygiene instructions

Control Group

ACTIVE COMPARATOR

Systemically Healthy (age and BMI matched) females with gingivitis will receive with OHI and scaling.

Interventions

scaling and OHIProcedure

patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive scaling and oral hygiene instructions

Test group 1

oral Hygiene instructionsProcedure

patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only

Also known as: Education and motivation

Eligibility Criteria

Age15 Years - 40 Years

Sexfemale(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

\- For test groups
females of reproductive age group (15-40 yrs)

Sponsors & Collaborators

Postgraduate Institute of Dental Sciences Rohtak
Otherlead

Study Sites (2)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Shikha Tewari

Rohtak, Haryana, 124001, India

MeSH Terms

Conditions

Gingivitis

Interventions

Tooth ExfoliationEducational Status

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaSocioeconomic FactorsPopulation Characteristics

Study Officials

RICHA VERMA
Post Graduate Institute of Dental Sciences,ROHTAK,HARYANA
PRINCIPAL INVESTIGATOR

Enrollment

79 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 22, 2021

First Posted

November 22, 2021

Study Start

January 1, 2022

Actual (reported)

Effect of EE/NETA With Scaling on Periodontium and hsCRP in PCOS Women With Gingivitis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (3)

Test group 1

Test group 2

Control Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (3)

Test group 1

Test group 2

Control Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations