NCT04259242

Brief Summary

To assess the impact of scaling and root planing on systemic inflammation and serum bone resorption markers in pre-menopausal women with periodontitis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

2.1 years

First QC Date

February 2, 2020

Last Update Submit

May 4, 2022

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (2)

  • Change in serum IL-6 .

    change in serum IL-6

    8 weeks

  • serum CTX-1

    Change in serum CTX-1

    8 WEEKS

Secondary Outcomes (3)

  • Platelet count

    8 weeks

  • PMV

    8 weeks

  • PDV

    8 weeks

Study Arms (1)

premenopausal women with periodontitis

EXPERIMENTAL

Experimental: premenopausal women with periodontitis premenopausal women with chronic periodontitis will be evaluated after SRP for serum bone resorption markers - CTX and inflammatory markers IL-6

Procedure: SRP

Interventions

SRPPROCEDURE

scaling and root planing with ultrasonic scaler and manual instruments

premenopausal women with periodontitis

Eligibility Criteria

Age40 Years - 46 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pre-menopausal women ( Pre-menopause was defined as women above 40 years of age with regular menstruation).
  • Periodontitis with 20 or more natural teeth (excluding third molars). Periodontitis criteria
  • Periodontal classification stage 2 and stage 3 ( 2017 World Workshop on classification of Periodontal and peri-implant Disease and conditions)
  • Bleeding on probing with more than 30% site ( 2017 World Workshop on classification of Periodontal and peri-implant Disease and conditions)

You may not qualify if:

  • Systemic inflammatory diseases known to affect BMD such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, and chronic obstructive pulmonary disease.
  • History of diabetes, metabolic bone disease, thyroid and parathyroid disease, and gastrointestinal disorders
  • Treatment with the following drugs in the previous 3 months : steroids, immunosuppressants, antibiotics, NSAIDs ,statins, lipid lowering drugs, anticonvulsants, thiazide diuretic agents, anti-coagulants, oral contraceptive drugs or any other host modulatory drug
  • Recent history or presence of acute or chronic infection
  • Previous history of treatment for osteoporosis/osteopenia.
  • Current or former smokers or use of smokeless tobacco in any form
  • pregnant and lactating mothers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Pradeep Sharma

    POST GRADUATE INSTITUTE OF DENTAL SCIENCES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2020

First Posted

February 6, 2020

Study Start

January 1, 2020

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

study protocol

Shared Documents
STUDY PROTOCOL

Locations

IN(1)