Assessment of Heat Generation From Low Speed Drilling Without Irrigation

November 15, 2018 updated by: Mahmoud Abdel Sattar Abdel Motagly, Cairo University

ASSESSEMENT OF LOW SPEED DRILLING WITHOUT IRRIGATION VERSUS CONVENTIONEL DRILLING WITH IRRIGATION REGARDING HEAT GENERATION AND PERI-IMPLANT MARGINAL BONE LOSS

ASSESSMENT OF LOW SPEED DRILLING WITHOUT IRRIGATION VERSUS CONVENTIONAL DRILLING WITH IRRIGATION REGARDING HEAT GENERATION AND PERI-IMPLANT MARGINAL BONE LOSS

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Assessment of heat generation from conventional drilling speed for dental implant placement versus biological drilling (low speed without irrigation ) by thermocouples technology And measure the primary stability of dental implants placed by the two techniques by osstel device

Study Type

Interventional

Enrollment (Anticipated)

2

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
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: both sex no intraoral soft and hard tissue pathology no systemic condition that contraindicate implant placement adult patients with proper posterior mandibular ridge requires implant placement

Exclusion Criteria:

presence of pathological lesions heavy smokers more than 20 cigarettes per day patients with systemic disease that may affect normal healing Patients with no enough bone in posterior mandible for implant placement

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: conventional drilling with irrigation
Other: low speed drilling without irrigation
comparing between conventional implant placement drilling speed with irrigation and experimental arm (low speed without irrigation)
EXPERIMENTAL: low speed without irrigation
Other: low speed drilling without irrigation
comparing between conventional implant placement drilling speed with irrigation and experimental arm (low speed without irrigation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of heat generation from low speed hand piece drills drilling by thermocouple technology
Time Frame: 6 months
Measurement of 3 different depths(mms). Data analyzed with a three-way analysis of variance by Newman-Keulsmultiple comparison procedure. The significance level was set to a p-value of 0.05.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stability-osstell device to assess the primary stability of placed dental implant
Time Frame: 6 months
Resonance frequency analysis (RFA) allows assess implant stability by measuring implant oscillation frequency on the bone
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

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 (ANTICIPATED)

December 1, 2018

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

April 2, 2019

Study Registration Dates

First Submitted

November 4, 2018

First Submitted That Met QC Criteria

November 14, 2018

First Posted (ACTUAL)

November 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 28601270201414

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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