The efficacy of Simvastatin in maxillary sinus augmenttion: a randomized controlled trial (histomorphometric and radiographic evaluation)

Phase 2

• Conditions: alveolar bone deficiency-maxillary sinus pneumatization.; Diseases of the musculoskeletal system and connective tissue

• Registration Number: IRCT2016062527240N1
• Lead Sponsor: Vice Chancellor for research of Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Patients who desiring to receive maxillary posterior implants and did not have sufficient bone as determined on cone beam computerized scan (CBCT) for dental implant placement; patients will be partially or completely edentulous in the posterior maxilla, all of them will need bilateral maxillary sinus augmentation surgeries.
Exclusion criteria:
Patients needing antibiotic prophylaxis for dental procedures; any sinus pathology (acute or chronic) contraindicating the sinus grafting;patients with systemic disease that contraindicating any oral surgeries; patients who smoked more than 10 cigarettes daily; women who were pregnant or wished to become pregnant during the period of the study; patients under 18 years of old; patients with diseases or use of medications known to affect bone metabolism ,tissue regeneration and repair such as corticosteroids, bisphosphonates and etc.; patients with a history of alcoholism or recreational drug abuse; patients who had a history of cancer, radiation to the head and neck in the last 18 months.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Human maxillary sinus bone augmentation by zenograft with or without simvastatin. Timepoint: Preoperatively ,immediately after surgery and at 6 months after sinus graft. Method of measurement: Histomorphometric and radiographic evaluation.

Secondary Outcome Measures

Name	Time	Method
ew bone formation. Timepoint: At 6 months after sinus graft. Method of measurement: Histomorphometric analysis percent.;Connective tissue. Timepoint: At 6 months after sinus graft. Method of measurement: Histomorphometric analysis percent.;Residual graft material. Timepoint: At 6 months after sinus graft. Method of measurement: Histomorphometric analysis percent.;Bone height analysis. Timepoint: Preoperatively ,immediately after surgery and at 6 months after sinus graft. Method of measurement: CBCT analysis.;Bone density analysis. Timepoint: 6 months after sinus graft. Method of measurement: CBCT analysis.