Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis

NCT02808988 | Completed Phase 4

• 1 other identifier: OMÜ KAEK 2012/138
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators evaluated the effect of initial periodontal treatment on clinical findings and receptor activator of Nuclear Factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) in gingival crevicular fluid (GCF) of patients with osteoporosis under bisphosphonate therapy within 12 months' follow-up. Clinical recordings and GCF were obtained from postmenopausal women; with chronic periodontitis and osteoporosis (Group A, n=13), with chronic periodontitis and no osteoporosis (Group B, n=12), without chronic periodontitis and osteoporosis (Group C, n=12), systemically and periodontally healthy controls (Group D, n=10) at the baseline. Recordings were repeated at the 1st, 6th and 12th months in Group A, B and C. RANKL and OPG values were measured by enzyme-linked immunosorbent assays.

Conditions

Chronic Periodontitis

Keywords

Bisphosphonate; osteoporosis; RANKL; OPG; periodontitis

Outcome Measures

Primary Outcomes (1)

• Gingival crevicular fluid levels of osteoprotegerin (OPG) and receptor activator of Nuclear Factor-kappa B ligand (RANKL)

  molecules having roles in bone resorption

  Changes from Baseline osteoprotegerin (OPG) and receptor activator of Nuclear Factor-kappa B ligand (RANKL) at 12 months

Study Arms (4)

group A

ACTIVE COMPARATOR

periodontal phase 1 therapy consisted of scaling and root planning, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection

Procedure: periodontal phase 1 therapy; Other: zoledronic acid

group B

ACTIVE COMPARATOR

periodontal phase 1 therapy consisted of scaling and root planning, no bisphosphonate therapy,gingival crevicular fluid collection

Procedure: periodontal phase 1 therapy

group C

ACTIVE COMPARATOR

no periodontal phase 1 therapy, bisphosphonate therapy (zoledronic acid), gingival crevicular fluid collection

Procedure: gingival crevicular fluid collection; Other: zoledronic acid

group D

ACTIVE COMPARATOR

no periodontal phase 1 therapy, no bisphosphonate therapy,gingival crevicular fluid collection

Procedure: gingival crevicular fluid collection

Interventions

periodontal phase 1 therapy PROCEDURE

periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia and gingival crevicular fluid collection by the same investigator.

group A; group B

gingival crevicular fluid collection PROCEDURE

gingival crevicular fluid collection by periopapers

group C; group D

zoledronic acid OTHER

5 mg/year zoledronic acid (i.v.)

group A; group C

Eligibility Criteria

• Age: 50 Years - 66 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Related Publications (7)

• Anastasilakis AD, Goulis DG, Polyzos SA, Gerou S, Koukoulis G, Kita M, Avramidis A. Serum osteoprotegerin and RANKL are not specifically altered in women with postmenopausal osteoporosis treated with teriparatide or risedronate: a randomized, controlled trial. Horm Metab Res. 2008 Apr;40(4):281-5. doi: 10.1055/s-2008-1046787. Epub 2008 Feb 15.

  PMID: 18275008 BACKGROUND

• 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.

  PMID: 16018754 RESULT

• Mogi M, Otogoto J, Ota N, Togari A. Differential expression of RANKL and osteoprotegerin in gingival crevicular fluid of patients with periodontitis. J Dent Res. 2004 Feb;83(2):166-9. doi: 10.1177/154405910408300216.

  PMID: 14742657 RESULT

• Bostanci N, Ilgenli T, Emingil G, Afacan B, Han B, Toz H, Atilla G, Hughes FJ, Belibasakis GN. Gingival crevicular fluid levels of RANKL and OPG in periodontal diseases: implications of their relative ratio. J Clin Periodontol. 2007 May;34(5):370-6. doi: 10.1111/j.1600-051X.2007.01061.x. Epub 2007 Mar 13.

  PMID: 17355365 RESULT

• Babur C, Ozcan G, Cebi DU, Pervane B, Ozdemir B, Yucel A, Biri AA, Babur C. Gingival crevicular fluid levels of osteoprotegerin (OPG) in premenopausal and postmenopausal women with or without chronic periodontitis. J Dent. 2012 May;40(5):364-71. doi: 10.1016/j.jdent.2012.01.013. Epub 2012 Feb 2.

  PMID: 22326720 RESULT

• Gumus P, Buduneli E, Biyikoglu B, Aksu K, Sarac F, Nile C, Lappin D, Buduneli N. Gingival crevicular fluid, serum levels of receptor activator of nuclear factor-kappaB ligand, osteoprotegerin, and interleukin-17 in patients with rheumatoid arthritis and osteoporosis and with periodontal disease. J Periodontol. 2013 Nov;84(11):1627-37. doi: 10.1902/jop.2013.120595. Epub 2013 Jan 17.

  PMID: 23327689 RESULT

• Bostanci N, Saygan B, Emingil G, Atilla G, Belibasakis GN. Effect of periodontal treatment on receptor activator of NF-kappaB ligand and osteoprotegerin levels and relative ratio in gingival crevicular fluid. J Clin Periodontol. 2011 May;38(5):428-33. doi: 10.1111/j.1600-051X.2011.01701.x. Epub 2011 Jan 24.

  PMID: 21261673 RESULT

MeSH Terms

Conditions

Chronic Periodontitis; Osteoporosis; Periodontitis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eser Sakallıoğlu, PhD,Prof.Dr.

  Ondokuz Mayıs University, School of Dentistry, Department of Periodontology, Samsun, Turkey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 22, 2016
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 22, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share