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

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Status and phase: Completed; Phase 4

Conditions: Intrabony Periodontal Defect

Treatments: Drug: Alendronate sodium; Biological: beta-tricalcium phosphate bone substitute

Study type: Interventional

Funder types: Other

Identifiers

NCT02795546

PMVIDS/PER/0029/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Test group

Experimental group

Description:

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.

Treatment:

Biological: beta-tricalcium phosphate bone substitute

Drug: Alendronate sodium

Control group

Active Comparator group

Description:

β-TCP + saline Beta-tricalcium phosphate bone substitute and wetted with saline and used as bone grafting material in periodontal intra-osseous defects.

Treatment:

Biological: beta-tricalcium phosphate bone substitute