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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016062527240N1
Enrollment
24
Registered
2016-07-16
Start date
2016-08-31
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

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

Interventions

Intervention 1: Intervention group: zenograft + simvastatin solution. Intervention 2: Control group: zenograft alone.
Treatment - Surgery
Intervention group: zenograft + simvastatin solution
Control group: zenograft alone

Sponsors

Vice Chancellor for research of Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
New 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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactChokami Rafiei Sahar

Peridontology Department, Dental Faculty of Tehran University of Medical Sciences

Sahar_rafiei87@yahoo.com+98 21 8835 1170

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026