NCT04261491

Brief Summary

This study is designed to determine the effect of treating postmenopausal women and using non-surgical techniques on biomarkers of systemic inflammation (IL-6 ) and systemic bone resorption (C-terminal collagen cross-links, CTX).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

2.1 years

First QC Date

February 3, 2020

Last Update Submit

April 26, 2022

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (2)

  • serum IL-6,

    change in serum IL-6,

    2 months

  • s-CTX

    change in serum carboxy terminal collagen cross links

    2 months

Secondary Outcomes (3)

  • Platelet count

    2 months

  • platelet distribution width PDW

    2 months

  • mean platalet volume

    2 months

Study Arms (1)

postmenopausal women with chronic periodontitis

EXPERIMENTAL

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

Procedure: scaling and root planing

Interventions

scaling and root planingPROCEDURE

scaling and root planing

postmenopausal women with chronic periodontitis

Eligibility Criteria

Age52 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details52-70 years of females with Chronic Periodontitis
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females in natural menopause since at least 5 years
  • Periodontitis with 20 or more natural teeth (excluding third molars). Periodontitis criteria
  • Periodontal classification stage 2 or stage 3 (2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions)

You may not qualify if:

  • Systemic disease known to effect BMD including rheumatoid arthritis, ankylosing spondylitis, and chronic obstructive pulmonary disease.
  • Systemic disease known to affect the course of periodontal disease like diabetes mellitus or immunologic disorders
  • Treatment with the following drugs in the previous 3 months: steroids, immune suppressants, antibiotics, anti-inflammatory drugs, statins, anti-convulsants, thiazide diuretic agents, anti-coagulants, or any other host modulatory drugs
  • Recent history or presence of acute or chronic infection.
  • History of metabolic bone disease, thyroid and parathyroid disease, and gastrointestinal disorders
  • Early onset of menopause
  • Treatment for low BMD with systemic medication including calcium and vitamin D supplementation, bisphosphonates, and hormone replacement therapy
  • History of hysterectomy
  • Current or former smokers or use of smokeless tobacco in any form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

Sanjay Tewari

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • ROMA RATHEE

    POST GRADUATE INSTITUTE OF DENTAL SCIENCES

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 7, 2020

Study Start

December 1, 2019

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

study protocol

Shared Documents
STUDY PROTOCOL

Locations

IN(2)