NCT04189718

Comparative Evaluation of Osseodensification Versus Conventional Implant Site

A Clinical and Radiological Comparison of Osseodensification Versus Conventional Implant Site Preparation Protocol During Dental Implant Placement. A Randomised Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Bone Density
• Implant Stability

Interventions

Type	Name	Description
PROCEDURE	osseodensification protocol	Local anaesthesia was administered and mucoperiosteal flap was reflected. Implant osteotomies was performed with sequential drilling with osseodensification protocol at 1100 rpm. The pilot drill was used in clockwise direction and the other sequential drills were used in counter clockwise direction under copious irrigation. Flap closure was achieved using 3-0 silk sutures to protect the implant site.
PROCEDURE	conventional implant site preparation protocol	Local anaesthesia was administered and mucoperiosteal flap was reflected. Implant osteotomies was performed with sequential drilling with conventional implant site preparation protocol at 1100 rpm. The pilot drill was used in clockwise direction and the other sequential drills were used in clockwise direction under copious irrigation. Flap closure was achieved using 3-0 silk sutures to protect the implant site.

Timeline

• Start date: 2017-11-30
• Primary completion: 2019-10-15
• Completion: 2019-10-30
• First posted: 2019-12-06
• Last updated: 2019-12-06

Locations

1 site across 1 country: India