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

Phase 4

Completed

• Conditions: Intrabony Periodontal Defect
• Interventions: Drug: Alendronate sodium; Biological: beta-tricalcium phosphate bone substitute

• Registration Number: NCT02795546
• Lead Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

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.

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 Timeline

• Study Start: 2015-01
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Study First Submitted: 2016-05-31
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-06
• Last Update Submitted: 2016-06-06
• Study First Posted: 2016-06-10
• Last Update Posted: 2016-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Alendronate sodium	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.
Test group	beta-tricalcium phosphate bone substitute	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.
Control group	beta-tricalcium phosphate bone substitute	β-TCP + saline Beta-tricalcium phosphate bone substitute and wetted with saline and used as bone grafting material in periodontal intra-osseous defects.

Primary Outcome Measures

Name	Time	Method
Linear bone growth	change from baseline and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
clinical attachment level (CAL)	change from baseline and 6 months	distance between the cemento-enamel junction and base of the pocket