CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 47 enrolled
Drug / intervention
periodontal phase 1 therapy +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02808988
NCT02808988Phase 4Completed

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

Ondokuz Mayıs University·interventional·Posted Jun 22, 2016·Updated Jun 22, 2016

In Brief

A Phase 4 clinical trial evaluating periodontal phase 1 therapy, gingival crevicular fluid collection, and 1 other intervention for Chronic Periodontitis. Completed, enrolled 47 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 22, 2016
Enrollment StartOct 1, 2013
Primary CompletionOct 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 10.0 years ago

Interventions

periodontal phase 1 therapyprocedure

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 collectionprocedure

gingival crevicular fluid collection by periopapers

zoledronic acidother

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