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

Intrabony Periodontal Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02795546
• Other study ID #: PMVIDS/PER/0029/2014
• Status: Completed
• Phase: Phase 4
• First received: May 31, 2016
• Last updated: June 6, 2016
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intrabony Periodontal Defect

Intervention

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.

Biological:
• beta-tricalcium phosphate bone substitute
beta-tricalcium phosphate bone graft is implanted in periodontal intra-osseous defects.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

References & 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 M — View Citation

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 M — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	clinical attachment level (CAL)	distance between the cemento-enamel junction and base of the pocket	change from baseline and 6 months	No