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Phase 4 N=43 Single-blind Diagnostic

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

Osteoporosis, Postmenopausal · Periodontitis

Enrolled (actual)
43
Serious AEs
Results posted
Dec 2020
Primary outcome: Primary: Sost Values for 6th Month — 1389.177; 1085.405; 1596.585; 2131.87 ng/ml — p=<0.01

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Phase 1 periodontal therapy (Procedure); Bisphosphonate therapy (Drug)
Age
Adult, Older Adult · 51+ yrs
Sex
Female
Sponsor
Ondokuz Mayıs University
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Sost Values for 6th Month
1389.177; 1085.405; 1596.585; 2131.87 <0.01 sig
PRIMARY
Dkk-1 Values for 6th Month
3358.265; 1963.185; 3263.665; 4269.39 <0.05 sig
SECONDARY
Sost Values for 12th Month
1702.265; 1347.330; 1114.988; 2131.87 <0.05 sig
SECONDARY
Dkk-1 Values for 12th Month
3440.67; 3203.802; 2490.553; 4269.39 <0.05 sig

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04149405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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