Effect of Different Drilling Techniques on Primary Stability and Marginal Bone Loss of Extra Short Implants

January 28, 2024 updated by: Ömer Faruk Okumuş, Erzincan University

The Effect of Low Speed Drilling Without Irrigation Versus Conventional Drilling With Irrigation in Extra Short Implants on Primary Stability and Marginal Bone Loss

Our aim in this study is to compare the effects of low-speed drilling surgery technique without irrigation and conventional implant surgery technique with irrigation on extra short implants. The criteria to be taken into consideration when investigating the effect of these techniques on implants are as follows: evaluation of osseointegration at the end of three months, evaluation of marginal bone loss at the end of three months, initial insertion torque values (maximum insertion torque and final insertion torque), ISQ values obtained with a radiofrequency analyzer (Osstel) at the beginning and at the end of three months.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • There must be toothless space in the maxillary and mandibular posterior region (distal part of the canine in each quadrant).
  • The edentulous space should not require additional bone grafting.
  • Bleeding areas on probing should be less than 10%
  • There should be no pathological periodontal pockets
  • Patients who do not smoke or smoke less than 10 cigarettes
  • There should be no bruxism
  • At least 6 months must have passed since the last tooth extracted from the toothless space where the implant is planned.
  • There should be no diabetes.

Exclusion Criteria:

  • Having psychological problems
  • Smoking more than 10 cigarettes
  • Alcohol and drug use
  • Pregnancy

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: Low Speed Drilling Without Irrigation
Procedure: Low Speed Drilling Without Irrigation
It is performed to reconstruct lost teeth. These are surgical procedures performed to place dental implants in the jaw bones. To prepare the implant socket, drilling is performed at a speed of 50 rpm without serum irrigation.
Active Comparator: Conventional Drilling with Irrigation
Procedure: Conventional dental implant surgery
It is performed to reconstruct lost teeth. These are surgical procedures performed to place dental implants in the jaw bones. To prepare the implant socket, drilling is performed with serum irrigation at a speed of 800 rpm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the status of osseointegration
Time Frame: Three months after the implant is placed in the bone. At the end of three months
Fusion of the dental implant with the bone at the microscopic level. Osseointegration will be evaluated as successful or unsuccessful. Successful osseointegration is defined by no mobility in the implant, no radiolucency around the implant on radiography, and no pain in the implant. Otherwise, the osseointegration of the implant is considered unsuccessful.
Three months after the implant is placed in the bone. At the end of three months
Marginal bone lose
Time Frame: Three months after the implant is placed in the bone. At the end of three months
It defines the change in the marginal bone level in the neck area of the implant. It is determined by radiographic examination. The initial radiograph is compared with the radiograph at the end of three months. In measurements where the implant platform is the reference point, bone level changes are calculated in mm.
Three months after the implant is placed in the bone. At the end of three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insertion Torque value
Time Frame: Surgical stage where the implant is placed
It is the amount of compression of the implant when screwed into the bone. The value detected by the electronic device that screws the implant into the bone cavity during screwing. It is expressed in Newtons.
Surgical stage where the implant is placed
Implant Stability Quotient (ISQ Value)
Time Frame: 1- Surgical stage where the implant is placed; 2- Three months after the implant is placed in the bone. At the end of three months
The value obtained by the resonance frequency analysis (RFA) device used to measure the primary stability of dental implants. The RFA technique is based on continual excitation of the implant through dynamic vibration analysis. A transducer is connected to an implant, which is excited over a range of sound frequencies with subsequent measurement of the vibratory oscillation of the implant. It is a non-invasive technique.
1- Surgical stage where the implant is placed; 2- Three months after the implant is placed in the bone. At the end of three months

Collaborators and Investigators

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

Sponsor

Erzincan University

Collaborators

Mode Medical Implant Manufacturer

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

December 27, 2024

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Estimated)

January 31, 2024

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EUDF-OKUMUS-001

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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