Comparative Evaluation of Osseodensification Versus Conventional Implant Site

Krishnadevaraya College of Dental Sciences & Hospital

Status: Completed

Conditions: Implant Stability; Bone Density

Treatments: Procedure: conventional implant site preparation protocol; Procedure: osseodensification protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04189718

02_D012_80824

Details and patient eligibility

About

The present study is a human, prospective, randomised controlled clinical trial conducted to explore and compare the clinical and radiological outcome of Osseodensification protocol with conventional implant site preparation protocol. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Full description

Twenty two dental implants were placed in twelve healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients.

All the patients received Norris implant. the implant site preparation technique being Osseodensification protocol for the test group and conventional implant site preparation protocol for the control group, eleven in each group. The clinical and radiographic parameters were recorded at baseline, immediate post implant placement, six months and twelve months postoperatively.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Single/multiple missing teeth in the maxillary anterior/posterior region.
2. Bone density of D2 or D3 (Carl E.Misch).
3. Patients between 18-75 years.
4. Patients who demonstrate good plaque control (PI<10%) and showing good compliance.
5. Patients willing to participate in the study.

Exclusion Criteria:-

1. Insufficient density or height of residual ridge.
2. Patients with bleeding disorder or on anticoagulant therapy.
3. Pregnant and lactating females.
4. Patients with history of smoking.
5. Use of systemic antibiotics in the past 3 months.
6. Patients treated with any medication known to cause periodontal changes.
7. Drug and alcohol abuse.
8. Occlusal interferences.
9. Patients with history of titanium allergy.
10. Immunocompromised state and debilitating disease.
11. Malignancy or radiotherapy/chemotherapy for malignancy.
12. Systemic diseases that would negatively influence wound healing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

osseodensification protocol

Experimental group

Description:

Experimental: In the test group, osteotomy site preparation was performed using Osseodensification technique at 1100 rpm and implant was placed

Treatment:

Procedure: osseodensification protocol

Procedure: conventional implant site preparation protocol

conventional implant site preparation protocol

Active Comparator group

Description:

Control: in the control group, osteotomy site was prepared using conventional drilling protocol at 1100 rpm and implant was placed.

Treatment:

Procedure: osseodensification protocol

Procedure: conventional implant site preparation protocol