is the Sclerostin Marker of Chronic Periodontitis (itsmcp)

• ClinicalTrials.gov Identifier: NCT03639636
• Recruitment Status: Completed
• First Posted: August 21, 2018
• Last Update Posted: August 21, 2018
• Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Information provided by (Responsible Party): Banda Madhavi, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Periodontitis	Other: non surgical and surgical periodontal therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Intervention Model: Sequential Assignment
• Intervention Model Description: interventional prospective study
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Comparative Evaluation of Serum Sclerostin in Chronic Periodontitis Patients Before and After Surgical Periodontal Therapy in Conjunction With Nonsurgical Periodontal Therapy
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: December 20, 2017
• Actual Study Completion Date: May 15, 2018

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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),

Secondary Outcome Measures :

1. sclerostin level response to periodontal surgery [ Time Frame: 6 weeks ]
   measuring serum sclerostin levels after surgery in pg/ml(Pico grams per milli liter)

Other Outcome Measures:

1. periodontal parametors [ Time Frame: 0-4-6 weeks ]
   pocket probing depth,Clinical Attachment Level(CAL), both are in mm

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

India

Panineeya Institute of Dentalsciences and Research Center

Hyderabad, Telangana, India, 500060

Sponsors and Collaborators

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Investigators

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

More Information

Publications of Results:

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-κB Ligand in Periodontitis. J Periodontol. 2015 Dec;86(12):1396-404. doi: 10.1902/jop.2015.150270. Epub 2015 Sep 14.

Other Publications:

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.

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.

• Responsible Party: Banda Madhavi, Dr.banda madhavi, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• ClinicalTrials.gov Identifier: NCT03639636
• Other Study ID Numbers: madhavisclerostin
• First Posted: August 21, 2018
• Last Update Posted: August 21, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Banda Madhavi, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre:

periodontitis; sclerostin; periodontal surgery; scaling and root planing

Additional relevant MeSH terms:

Periodontitis; Chronic Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases