Alterations of GCF Levels of Sclerostin and DKK-1 in Postmenopausal Osteoporosis

Periodontitis Clinical Trial

Official title:

Investigation of the Effects of Bisphosphonate on the Gingival Crevicular Fluid Levels of Sclerostin and the DKK-1 in Individuals With Postmenopausal Osteoporosis With Periodontal Changes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149405
• Other study ID #: KAEK 2016/100
• Status: Completed
• Phase: Phase 4
• Start date: June 30, 2016
• Est. completion date: December 28, 2018

Study information

• Verified date: November 2020
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Symptoms of periodontal disease are tissue destruction and destruction of the alveolar bone which supports the tooth. Wnt way (wingless-type MMTV integration site family) plays a role in the regulation of bone homeostasis in periodontal disease-induced bone resorption. The Wnt / β-catenin signal is controlled by physiological antagonists, including dickkopf released from osteocytes-associated protein 1 (DKK-1) and sclerostin (SOST). Thus, Wnt inhibitors SOST and DKK-1 affect bone mass changes. Bisphosphonates used in osteoporous treatment are selective inhibitors of bone resorption. In the serum of postmenopausal osteoporotic women treated with bisphosphonate, short-term and decreased DKK-1 level during the treatment, and increased SOST in the late period were reported. Increased bone formation after bisphosphonate treatment in postmenopausal osteoporotic patients has been associated with increased serum SOST level. The aim of our study is to investigate the effect of bisphosphonate in patients with post-menopausal osteoporosis on the bone demolition metabolism in periodontally healthy and periodontally diseased tooth regions and gingival health with the clinical data by investigating the SOST and DDK-1 molecules that play role in bone destruction mechanism.

Description:

This study aims to reveal the effect of initial periodontal treatment together with bisphosphonate on sclerostin (SOST) and dickkopf-related protein-1 (DKK-1) in gingival crevicular fluid (GCF) of patients with osteoporosis. Clinical recordings and GCF were obtained from postmenopausal women; with chronic periodontitis and those using bisphosphonate (Group A, n=12), with chronic periodontitis and otherwise healthy (Group B, n=10), without chronic periodontitis and those using bisphosphonate (Group C, n=11), systemically and periodontally healthy controls (Group D, n=10) at the baseline. GCF sampling were recorded and repeated at the 6th and 12th months in Group A, B and C. SOST and DKK-1 values were measured by ELISA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 28, 2018
• Est. primary completion date: December 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 51 Years to 66 Years

Eligibility

Inclusion Criteria:

• Women with T scores less than -2.5 (groups A and C)
• The periodontitis patients were selected based on the radiographical evidence of bone loss, presence of four or more sites with bleeding on probing (BOP), =5 mm pocket depth (PD) and =6 mm clinical attachment loss (CAL).
• The clinically healthy control groups were selected on the basis of no radiographic bone loss or CAL and PD=3 mm.

Exclusion Criteria:

• Any known systemic disease rather than osteoporosis
• Smoking
• Antibiotic therapy within the last 3 months
• Periodontal treatment in the last 6 months

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Periodontitis

Intervention

Procedure:
• Phase 1 periodontal therapy
Scaling and root planning with ultrasonic and hand instruments under local anesthesia.

Drug:
• Bisphosphonate therapy
Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

References & Publications (6)

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

Hampson G, Edwards S, Conroy S, Blake GM, Fogelman I, Frost ML. The relationship between inhibitors of the Wnt signalling pathway (Dickkopf-1(DKK1) and sclerostin), bone mineral density, vascular calcification and arterial stiffness in post-menopausal women. Bone. 2013 Sep;56(1):42-7. doi: 10.1016/j.bone.2013.05.010. Epub 2013 May 20. — View Citation

Juluri R, Prashanth E, Gopalakrishnan D, Kathariya R, Devanoorkar A, Viswanathan V, Romanos GE. Association of Postmenopausal Osteoporosis and Periodontal Disease: A Double-Blind Case-Control Study. J Int Oral Health. 2015 Sep;7(9):119-23. — View Citation

Lane N, Armitage GC, Loomer P, Hsieh S, Majumdar S, Wang HY, Jeffcoat M, Munoz T. Bisphosphonate therapy improves the outcome of conventional periodontal treatment: results of a 12-month, randomized, placebo-controlled study. J Periodontol. 2005 Jul;76(7) — View Citation

Napimoga MH, Nametala C, da Silva FL, Miranda TS, Bossonaro JP, Demasi AP, Duarte PM. Involvement of the Wnt-ß-catenin signalling antagonists, sclerostin and dickkopf-related protein 1, in chronic periodontitis. J Clin Periodontol. 2014 Jun;41(6):550-7. d — View Citation

Papapoulos SE, Landman JO, Bijvoet OL, Löwik CW, Valkema R, Pauwels EK, Vermeij P. The use of bisphosphonates in the treatment of osteoporosis. Bone. 1992;13 Suppl 1:S41-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sost Values for 6th Month	levels of sclerostin in 6th month	6 months
Primary	Dkk-1 Values for 6th Month	levels of dickkopf-related protein-1 in 6th month	6 months
Secondary	Sost Values for 12th Month	levels of sclerostin in 12th month	12 month
Secondary	Dkk-1 Values for 12th Month	levels of dickkopf-related protein-1 in 12th month	12 months