Effect of Alendronate With β - TCP Bone Substitute in Surgical Therapy of Periodontal Intra-osseous Defects.

Effect of Alendronate With β - TCP Bone Substitute in Surgical Therapy of Periodontal Intra-osseous Defects: A Randomized, Controlled Clinical Trial.

The aim of the present study was to evaluate the bone formation potential of 400µg alendronate delivered in β-TCP in the treatment of periodontal intra-osseous defects.

Study Overview

• Status: Completed
• Conditions: Intrabony Periodontal Defect
• Intervention / Treatment: Drug: Alendronate sodium; Biological: beta-tricalcium phosphate bone substitute

Detailed Description

The aim of the present study was to evaluate the bone formation potential of 400µg alendronate(ALN) delivered in β-TCP in the treatment of periodontal intra-osseous defects.

Materials and Methods: Thirty patients with periodontal defects were randomly assigned to 400µg ALN + β-TCP + saline (test) group and β-TCP + saline (active-control) group. Clinical parameters like clinical attachment level (CAL) gain, probing depth (PD) reduction, post-operative gingival recession (GR) were assessed from the baseline, 3 months and 6 months recordings. Radiographic parameters like linear bone growth (LBG), percentage bone fill (%BF), change in alveolar crest height (ACH) were assessed from baseline and 6 months radiographs.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Systemically healthy patients having an intra-osseous defect with probing depth ≥ 7mm at baseline, presence of a ≥ 4mm vertical inter-proximal bone defect with at least one bony wall after surgical debridement and with no history of previous periodontal therapy were included into the study

Exclusion Criteria:

• Patients with known systemic diseases, aggressive periodontitis, smoking habit, known or suspected allergy to bisphosphonates, pregnant and lactating women, study tooth exhibiting tooth mobility greater than grade II and class III furcation defect were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test group; 400µg Alendronate sodium+ β-TCP + saline. 400µg alendronate sodium is combined with beta-tricalcium phosphate bone substitute and wetted with saline and used as bone grafting material in periodontal intra-osseous defects.	Drug: Alendronate sodium; 400µg of alendronate sodium is combined with beta-tricalcium phosphate bone graft and implanted in periodontal intra-osseous defects as a single, local dose.; Other Names: fossamax, osteofos; Biological: beta-tricalcium phosphate bone substitute; beta-tricalcium phosphate bone graft is implanted in periodontal intra-osseous defects.; Other Names: cerasorb, sorbone
ACTIVE_COMPARATOR: Control group; β-TCP + saline Beta-tricalcium phosphate bone substitute and wetted with saline and used as bone grafting material in periodontal intra-osseous defects.	Biological: beta-tricalcium phosphate bone substitute; beta-tricalcium phosphate bone graft is implanted in periodontal intra-osseous defects.; Other Names: cerasorb, sorbone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linear bone growth	Linear bone growth (LBG) was calculated as the difference between the cemento-enamel junction(CEJ) to base of defect (BD) distance at baseline and CEJ to BD distance at 6 months in radiographs.	change from baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical attachment level (CAL)	distance between the cemento-enamel junction and base of the pocket	change from baseline and 6 months

Collaborators and Investigators

• Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Publications and helpful links

General Publications

• Gupta J, Gill AS, Sikri P. Evaluation of the relative efficacy of an alloplast used alone and in conjunction with an osteoclast inhibitor in the treatment of human periodontal infrabony defects: a clinical and radiological study. Indian J Dent Res. 2011 Mar-Apr;22(2):225-31. doi: 10.4103/0970-9290.84292.
• Sharma A, Pradeep AR. Clinical efficacy of 1% alendronate gel as a local drug delivery system in the treatment of chronic periodontitis: a randomized, controlled clinical trial. J Periodontol. 2012 Jan;83(1):11-8. doi: 10.1902/jop.2011.110091. Epub 2011 May 4.
• Veena HR, Prasad D. Evaluation of an aminobisphosphonate (alendronate) in the management of periodontal osseous defects. J Indian Soc Periodontol. 2010 Jan;14(1):40-5. doi: 10.4103/0972-124X.65438.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (ESTIMATE): June 10, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 10, 2016
• Last Update Submitted That Met QC Criteria: June 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: periodontal regeneration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate
• Other Study ID Numbers: PMVIDS/PER/0029/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: statistical data will be provided.