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Comparative Evaluation of Osseodensification Versus Conventional Implant Site

K

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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