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Study to evaluate whether simvastatin gel in dental implant improves implant stability and bone quality

Effect of local application of 1 percent simvastatin gel on implant stability and bone quality in delayed dental implant placement A split mouth randomized controlled study - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106518
Enrollment
30
Registered
2026-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: K069- Disorder of gingiva and edentulousalveolar ridge, unspecified

Interventions

Intervention1: 1 % Simvastatin gel: After completion of osteotomy preparation, freshly prepared 1% simvastatin gel will be injected into the osteotomy site using a sterile insulin syringe, and Implan

Sponsors

Karan Waghmare
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 21 60 years requiring placement of two dental implants, allowing one site to act as test and the other as control (split-mouth design). 2. Systemically healthy patients . 3. Partial edentulous ridges in maxilla and/or mandible. 4. Implant sites with D2 or D3 bone quality. 5. Adequate ridge height and width without need for bone augmentation. 6. Non-smokers and non-tobacco users. 7. Patients willing to give written informed consent. 8. Patient willing to undergo radiographic evaluation procedure.

Exclusion criteria

Exclusion criteria: 1. Any systemic diseases contraindicating implant surgery. 2. Immunocompromised patients or those on long-term steroid/bisphosphonate therapy. 3. Smokers and smokeless tobacco users. 4. Pregnant, lactating and postmenopausal women. 5. Active periodontal or oral infections. 6. Patients requiring simultaneous grafting procedures.

Design outcomes

Primary

MeasureTime frame
1. Primary Implant stability 2. Secondary Implant stability 3. Insertion torque 4. Evaluation of crestal bone loss through radiographs 5. Evaluation of Bone Quality Using Fractal Analysis (ImageJ Software)Timepoint: Baseline, 1.5 months, 3 months and 6 months

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactKaran Waghmare

Government Dental College And Hospital Mumbai

akshayabanodkar@gmail.com9004782725

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026