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Completed

NCT Number: NCT04189718

Comparative Evaluation of Osseodensification Versus Conventional Implant Site

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.

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Key information

Conditions

Bone Density Implant Stability

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

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

Treatment and study plan

osseodensification protocol

Procedure

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

conventional implant site preparation protocol

Procedure

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

Primary outcomes

  1. primary implant stability

    Time frame: immediate post implant placement

    the primary implant stability was measured during implant placement using Insertion Torque Value(ITV).

  2. 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

  3. 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

Secondary outcomes

  1. 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).

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2019
Registry last updated
Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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