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

Comparative Evaluation of Osseodensification Versus Conventional Implant Site

Sponsors

Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Source Krishnadevaraya College of Dental Sciences & Hospital
Brief 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.

Overall Status Completed
Start Date November 30, 2017
Completion Date October 30, 2019
Primary Completion Date October 15, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
primary implant stability immediate post implant placement
change from baseline in bone density 1 year
change from baseline in crestal bone level 1 year
Secondary Outcome
Measure Time Frame
change from baseline in keratinized mucosa width 1 year
change from baseline in ridge width 1 year
Patient reported pain evaluation (Visual Analog Scale) 1 year
Enrollment 22
Condition
Intervention

Intervention type: Procedure

Intervention name: osseodensification protocol

Description: 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.

Intervention type: Procedure

Intervention name: conventional implant site preparation protocol

Description: 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.

Other name: standard drilling technique, regular drilling technique

Eligibility

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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Location
facility Krishnadevaraya college of dental sciences
Location Countries

India

Verification Date

December 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Krishnadevaraya College of Dental Sciences & Hospital

Investigator full name: Dr Prabhuji MLV

Investigator title: Professor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: osseodensification protocol

Arm group type: Experimental

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

Arm group label: conventional implant site preparation protocol

Arm group type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: wo groups were made one test and control. The control group were treated with conventional implant site preparation technique and the test group were treated with osseodensification technique.

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov