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

NCT02795546 | Completed Phase 4 DMC

• 1 other identifier: PMVIDS/PER/0029/2014
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intrabony Periodontal Defect

Keywords

periodontal regeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• clinical attachment level (CAL)

  change from baseline and 6 months

Study Arms (2)

Test group

EXPERIMENTAL

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; Biological: beta-tricalcium phosphate bone substitute

Control group

ACTIVE COMPARATOR

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

Interventions

Alendronate sodium DRUG

400µg of alendronate sodium is combined with beta-tricalcium phosphate bone graft and implanted in periodontal intra-osseous defects as a single, local dose.

Also known as: fossamax, osteofos

Test group

beta-tricalcium phosphate bone substitute BIOLOGICAL

beta-tricalcium phosphate bone graft is implanted in periodontal intra-osseous defects.

Also known as: cerasorb, sorbone

Control group; Test group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (3)

• 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.

  PMID: 21891890 RESULT

• 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.

  PMID: 21542734 RESULT

• 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.

  PMID: 20922078 RESULT

MeSH Terms

Interventions

Alendronate; beta-tricalcium phosphate

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 10, 2016
• Study Start: January 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 10, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share