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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02795546
Enrollment
32
Registered
2016-06-10
Start date
2015-01-31
Completion date
2016-04-30
Last updated
2016-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrabony Periodontal Defect

Keywords

periodontal regeneration

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.

Interventions

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

BIOLOGICALbeta-tricalcium phosphate bone substitute

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

Sponsors

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Linear bone growthchange from baseline and 6 monthsLinear 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

MeasureTime frameDescription
clinical attachment level (CAL)change from baseline and 6 monthsdistance between the cemento-enamel junction and base of the pocket

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026