is the Sclerostin Marker of Chronic Periodontitis (itsmcp)

August 20, 2018 updated by: Banda Madhavi, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Comparative Evaluation of Serum Sclerostin in Chronic Periodontitis Patients Before and After Surgical Periodontal Therapy in Conjunction With Nonsurgical Periodontal Therapy

Reviewed literature suggests that sclerostin will inhibit the bone formation and ultimately leads to chronic periodontitis. Estimation of Sclerostin levels in the serum of periodontitis patients before and after intervention could explore the effectiveness of therapy and also give a more detailed insight into its diagnostic and prognostic potential as a biomarker of periodontal disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Advances during the last decade provided relevant information on the regulation of Sost/sclerostin and its mechanism(s) of action. Several stimuli have been reported to regulate Sost/Sclerostin expression, however how these factors interplay to regulate the expression of this gene in a spatiotemporal manner is unknown. Animal studies demonstrate that sclerostin is key for skeletal homeostasis, and required for the bone anabolic response to mechanical loading although appears dispensable for PTH-induced bone gain. The knowledge provided by preclinical investigations resulted in clinical trials based on the neutralization of sclerostin activity as a novel osteoanabolic therapeutic approach. It is now clear that sclerostin is capable of uncoupling bone formation and bone resorption, by inhibiting osteoblast function while stimulating osteoclast function, as the bone gain achieved by pharmacologic inhibition of sclerostin results from stimulation of osteoblast activity and inhibition of bone resorption. Furthermore, the recent observations show that activation of βcatenin in osteocytes increases bone resorption and Rankl production in a sclerostin-dependent manner. Anti-sclerostin therapy has shown beneficial skeletal outcomes in osteoporotic patients, however more recent evidence shows that the anabolic effects of this therapy attenuate with time and that after discontinuation BMD returns to pretreatment levels over time. The new evidence showing increased levels of Sost/sclerostin (and Dkk1) after activation of Wnt-βcatenin signaling suggest that sclerostin (and Dkk1) act as a negative feedback limiting bone formation stimulated by this pathway.

In this study is there any alterations in sclerostin levels in serum response to periodontal therapy was checked. Periodontal therapy alters the inflammation pathway is a proven fact.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500060
        • Panineeya Institute of Dentalsciences and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:• Systemically healthy individuals with more than 50% remaining natural teeth

  • All the patients who are diagnosed as having generalized chronic periodontitis based on the American Academy of Periodontology (AAP) classification.
  • Probing Pocket Depth (PPD)/ Clinical Attachment Loss(CAL) ≥ 5mm
  • Patients indicated for periodontal surgery

Exclusion Criteria:• The patients who have aggressive periodontitis/localized periodontitis

  • Patients having any other systemic diseases
  • Patients taking high-dose steroid therapy, radiation or immunosuppressive therapy and any other drug history.
  • Pregnant and lactating woman.
  • History of smoking within the past five years.
  • Patients who had undergone periodontal therapy in the last six months.
  • Intellectual disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: interventional prospective study
nonsurgical periodontal therapy(scaling and root planing) surgical therapy( flap surgery)
Other: non surgical and surgical periodontal therapy
scaling and root planing periodontal flap surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sclerostin level response to only scaling and root planing
Time Frame: 4 weeks
measuring serum sclerostin levels in pg/ml(Pico grams per milli liter),
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sclerostin level response to periodontal surgery
Time Frame: 6 weeks
measuring serum sclerostin levels after surgery in pg/ml(Pico grams per milli liter)
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
periodontal parametors
Time Frame: 0-4-6 weeks
pocket probing depth,Clinical Attachment Level(CAL), both are in mm
0-4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Investigators

  • Study Director: Jammula surya prasanna, mds, panineeya institute of dental sciences and research center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

December 20, 2017

Study Completion (Actual)

May 15, 2018

Study Registration Dates

First Submitted

August 10, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • madhavisclerostin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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