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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator |
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| Group B | Active Comparator |
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| Group C | Active Comparator |
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| Group D | No Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase 1 periodontal therapy | Procedure | Scaling and root planning with ultrasonic and hand instruments under local anesthesia. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sost Values for 6th Month | levels of sclerostin in 6th month | 6 months |
| Dkk-1 Values for 6th Month | levels of dickkopf-related protein-1 in 6th month | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sost Values for 12th Month | levels of sclerostin in 12th month | 12 month |
| Dkk-1 Values for 12th Month | levels of dickkopf-related protein-1 in 12th month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eser Acarel, PhD,Prof.Dr. | Ondokuz Mayıs University, School of Dentistry, Department of Periodontology | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23702386 | Background | 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. | |
| 1581119 |
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Smokers and subjects who had received antibiotic treatment in the last 3 months and/or periodontal treatment in the last 6 months were excluded from the study.
Postmenopausal women who were admitted to Ondokuz Mayıs University (OMU), Faculty of Medicine, Department of Endocrinology and Metabolism between 2016 and 2018.
Patients eligible for the study were directed to OMU, Faculty of Dentistry, Department of Periodontology for periodontal examination after obtaining medical records.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | subjects with chronic periodontitis and osteoporosis |
| FG001 | Group B | subjects with chronic periodontitis and systemically healthy |
| FG002 | Group C | subjects with periodontally healthy and osteoporosis |
| FG003 | Group D | systemically and periodontally healthy controls |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | subjects with chronic periodontitis and osteoporosis |
| BG001 | Group B | subjects with chronic periodontitis and systemically healthy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sost Values for 6th Month | levels of sclerostin in 6th month | Posted | Mean | Standard Deviation | ng/ml | 6 months |
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Adverse Events were not monitored/assessed
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in any participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Participants received periodontal phase 1 treatment and used bisphosphonate. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Feyza Otan Özden | OndokusMU | +905322535106 | feyza_otan@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 30, 2016 | Sep 11, 2020 | ICF_002.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 28, 2018 | Sep 11, 2020 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010518 | Periodontitis |
| C537525 | Sclerosteosis |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D010512 | Periodontal Index |
| ID | Term |
|---|---|
| D003753 | Dental Health Surveys |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
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| Bisphosphonate therapy | Drug | Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year |
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| 12 months |
| Papapoulos SE, Landman JO, Bijvoet OL, Lowik CW, Valkema R, Pauwels EK, Vermeij P. The use of bisphosphonates in the treatment of osteoporosis. Bone. 1992;13 Suppl 1:S41-9. doi: 10.1016/s8756-3282(09)80009-4. |
| 26435630 | Background | 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. |
| 16018754 | Result | 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):1113-22. doi: 10.1902/jop.2005.76.7.1113. |
| 26367496 | Result | 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. |
| 24576302 | Result | Napimoga MH, Nametala C, da Silva FL, Miranda TS, Bossonaro JP, Demasi AP, Duarte PM. Involvement of the Wnt-beta-catenin signalling antagonists, sclerostin and dickkopf-related protein 1, in chronic periodontitis. J Clin Periodontol. 2014 Jun;41(6):550-7. doi: 10.1111/jcpe.12245. |
| BG002 | Group C | subjects with periodontally healthy and osteoporosis |
| BG003 | Group D | systemically and periodontally healthy controls |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| baseline sost values | initial sclerostin values | Mean | Standard Deviation | ng/ml |
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| baseline dkk-1 levels | initial dickkopf-related protein-1 values | Mean | Standard Deviation | ng/ml |
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| OG002 | Group C | bisphosphonate therapy (zoledronic acid) bisphosphonate therapy: bisphosphonate therapy refers to the use of zoledronic acid 5 mg/year (i.v.) GCF: gingival crevicular fluid collection by the same investigator. |
| OG003 | Group D | Systemically and periodontally healthy controls No intervention has been made |
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| Primary | Dkk-1 Values for 6th Month | levels of dickkopf-related protein-1 in 6th month | Posted | Mean | Standard Deviation | ng/ml | 6 months |
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| Secondary | Sost Values for 12th Month | levels of sclerostin in 12th month | Posted | Mean | Standard Deviation | ng/ml | 12 month |
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| Secondary | Dkk-1 Values for 12th Month | levels of dickkopf-related protein-1 in 12th month | Posted | Mean | Standard Deviation | ng/ml | 12 months |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group B | Participants received periodontal phase 1 treatment. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Group C | Participants used bisphosphonate. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Group D | Participants did not receive any treatment. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003813 | Dentistry |
| D010517 | Periodontics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011636 | Public Health Dentistry |