Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis

Chronic Periodontitis Clinical Trial

Official title:

Effect of Periodontal Therapy and Bisphosphonates on Gingival Crevicular Fluid Levels of Nuclear Factor- κb Ligand (RANKL) and Osteoprotegerin in Postmenopausal Osteoporosis: Results of a 12-Month Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808988
• Other study ID #: OMÜ KAEK 2012/138
• Status: Completed
• Phase: Phase 4
• First received: May 27, 2016
• Last updated: June 19, 2016
• Start date: October 2013
• Est. completion date: November 2015

Study information

• Verified date: June 2016
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

The study groups were selected from postmenopausal patients those referred to Department of Endocrinology, School of Medicine, Ondokuz Mayis University. Bone mineral density (BMD) measurements were performed by dual energy-X-ray absorptiometry from L1-L4 site of lumbar vertebra and/or femur (g/cm2). Osteoporosis was defined as T scores less than -2.5 at L1-L4, femur neck or total femur. Women with T scores less than -2.5 (groups A and C) were started on bisphosphonate treatment after their initial periodontal examination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 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 within the last 6 months.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Chronic Periodontitis
• Osteoporosis
• Osteoporosis, Postmenopausal
• Periodontitis

Intervention

Procedure:
• periodontal phase 1 therapy
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.
• gingival crevicular fluid collection
gingival crevicular fluid collection by periopapers

Other:
• zoledronic acid
5 mg/year zoledronic acid (i.v.)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

References & 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. — View Citation

Babür C, Ozcan G, Cebi DU, Pervane B, Ozdemir B, Yücel A, Biri AA, Babür 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: 10.1 — View Citation

Bostanci N, Ilgenli T, Emingil G, Afacan B, Han B, Töz 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. Epub — View Citation

Bostanci N, Saygan B, Emingil G, Atilla G, Belibasakis GN. Effect of periodontal treatment on receptor activator of NF-?B ligand and osteoprotegerin levels and relative ratio in gingival crevicular fluid. J Clin Periodontol. 2011 May;38(5):428-33. doi: 10 — View Citation

Gümüs P, Buduneli E, Biyikoglu B, Aksu K, Saraç F, Nile C, Lappin D, Buduneli N. Gingival crevicular fluid, serum levels of receptor activator of nuclear factor-?B ligand, osteoprotegerin, and interleukin-17 in patients with rheumatoid arthritis and osteo — 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes