NCT03639636

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

August 10, 2018

Last Update Submit

August 20, 2018

Conditions

Keywords

periodontitissclerostinperiodontal surgeryscaling and root planing

Outcome Measures

Primary Outcomes (1)

  • sclerostin level response to only scaling and root planing

    measuring serum sclerostin levels in pg/ml(Pico grams per milli liter),

    4 weeks

Secondary Outcomes (1)

  • sclerostin level response to periodontal surgery

    6 weeks

Other Outcomes (1)

  • periodontal parametors

    0-4-6 weeks

Study Arms (1)

interventional prospective study

OTHER

nonsurgical periodontal therapy(scaling and root planing) surgical therapy( flap surgery)

Other: non surgical and surgical periodontal therapy

Interventions

scaling and root planing periodontal flap surgery

interventional prospective study

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Panineeya Institute of Dentalsciences and Research Center

Hyderabad, Telangana, 500060, India

Location

Related Publications (4)

  • Liu M, Kurimoto P, Zhang J, Niu QT, Stolina M, Dechow PC, Feng JQ, Hesterman J, Silva MD, Ominsky MS, Richards WG, Ke H, Kostenuik PJ. Sclerostin and DKK1 Inhibition Preserves and Augments Alveolar Bone Volume and Architecture in Rats with Alveolar Bone Loss. J Dent Res. 2018 Aug;97(9):1031-1038. doi: 10.1177/0022034518766874. Epub 2018 Apr 4.

    PMID: 29617179BACKGROUND
  • Chen H, Xu X, Liu M, Zhang W, Ke HZ, Qin A, Tang T, Lu E. Sclerostin antibody treatment causes greater alveolar crest height and bone mass in an ovariectomized rat model of localized periodontitis. Bone. 2015 Jul;76:141-8. doi: 10.1016/j.bone.2015.04.002. Epub 2015 Apr 11.

    PMID: 25868799BACKGROUND
  • Taut AD, Jin Q, Chung JH, Galindo-Moreno P, Yi ES, Sugai JV, Ke HZ, Liu M, Giannobile WV. Sclerostin antibody stimulates bone regeneration after experimental periodontitis. J Bone Miner Res. 2013 Nov;28(11):2347-56. doi: 10.1002/jbmr.1984.

  • Balli U, Aydogdu A, Dede FO, Turer CC, Guven B. Gingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin, and Receptor Activator of Nuclear Factor-kappaB Ligand in Periodontitis. J Periodontol. 2015 Dec;86(12):1396-404. doi: 10.1902/jop.2015.150270. Epub 2015 Sep 14.

MeSH Terms

Conditions

PeriodontitisSclerosteosis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Jammula surya prasanna, mds

    panineeya institute of dental sciences and research center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Model Details: interventional prospective study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.banda madhavi

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 21, 2018

Study Start

June 1, 2017

Primary Completion

December 20, 2017

Study Completion

May 15, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations