Comparative Evaluation of Osseodensification Versus Conventional Implant Site

December 4, 2019 updated by: Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 562157
        • Krishnadevaraya college of dental sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: osseodensification protocol
Experimental: In the test group, osteotomy site preparation was performed using Osseodensification technique at 1100 rpm and implant was placed
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.
Other Names:
  • Densah bur protocol
  • Osseodensification technique
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.
Other Names:
  • standard drilling technique, regular drilling technique
Active Comparator: conventional implant site preparation protocol
Control: in the control group, osteotomy site was prepared using conventional drilling protocol at 1100 rpm and implant was placed.
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.
Other Names:
  • Densah bur protocol
  • Osseodensification technique
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.
Other Names:
  • standard drilling technique, regular drilling technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
primary implant stability
Time Frame: immediate post implant placement
the primary implant stability was measured during implant placement using Insertion Torque Value(ITV).
immediate post implant placement
change from baseline in bone density
Time Frame: 1 year
A Multislice CT was used for scanning the implant site pre operatively, just after implant placement and 1 year post implant placement to measure the change in bone density. It was performed using a tube voltage of 120 kV(kilovolt) and a tube current of 40 mA(milliampere). The occlusal plane of the patient was set perpendicular to the floor base using ear rods. The axial images was reconstructed with 0.625 mm thick slices at 0.625 mm interval and a 1.75 mm field of view(FOV) image analysis software
1 year
change from baseline in crestal bone level
Time Frame: 1 year
Digital radiographs (radiovisiograph-RVG) were standardised using radiographic paralleling technique and positioning device and custom fabricated bite-block at baseline and follow up.Mesial and distal peri-implant radiographic bone level were recorded in millimetres on the digital radiographs using Digimiser image
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in keratinized mucosa width
Time Frame: 1 year
The width of keratinized mucosa was measured from the mucosal margin to the mucogingival junction at the facial surface. The mucogingival junction location was determined using a visual method (Schiller's potassium iodide solution).
1 year
change from baseline in ridge width
Time Frame: 1 year
Soft tissue and hard tissue labio-lingual ridge width was measured at baseline, immediate post implant placement, 6 months and 1 year after implant placement using ridge mapping calipers/Multislice CT.
1 year
Patient reported pain evaluation (Visual Analog Scale)
Time Frame: 1 year
patient were asked to report the pain after the procedure in terms of visual analog scale (VAS) score in a rating between 1 to 10. There are 5-point verbal descriptive scale with an interval of 2("nil," "mild," "moderate," "severe," and "very severe") Patients were asked to rate their pain in a score between 1-10
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Investigators

  • Principal Investigator: PRIYANKA ACHARYA, mds, Rajiv Gandhi University of Health Sciences
  • Study Director: prabhuji mlv, mds, Rajiv Gandhi University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2017

Primary Completion (Actual)

October 15, 2019

Study Completion (Actual)

October 30, 2019

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 6, 2019

Study Record Updates

Last Update Posted (Actual)

December 6, 2019

Last Update Submitted That Met QC Criteria

December 4, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 02_D012_80824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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