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Assessment of Heat Generation From Low Speed Drilling Without Irrigation

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ClinicalTrials.gov Identifier: NCT03743545
Recruitment Status : Unknown
Verified November 2018 by Mahmoud Abdel Sattar Abdel Motagly, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Mahmoud Abdel Sattar Abdel Motagly, Cairo University

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

Condition or disease Intervention/treatment Phase
Implant Site Reaction Other: low speed drilling without irrigation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: healthy posterior mandible
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ASSESSEMENT OF LOW SPEED DRILLING WITHOUT IRRIGATION VERSUS CONVENTIONEL DRILLING WITH IRRIGATION REGARDING HEAT GENERATION AND PERI-IMPLANT MARGINAL BONE LOSS
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : April 2, 2019
Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Mahmoud Abdel Sattar Abdel Motagly, director, Cairo University
ClinicalTrials.gov Identifier: NCT03743545    
Other Study ID Numbers: 28601270201414
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No