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Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group A ) A Randomized Controlled Clinical Trial

Primary Purpose

Bone Resorption

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Drilling at low speed
Conventional drilling at high speed
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Resorption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients restoring missing maxillary teeth with implant placement.
  • Both sexes.
  • Age: 25-45
  • Mesio-distal dimensions: Not less than 6 mm
  • Bone Height: Not less than 12 mm
  • Bucco-lingual dimensions: Not less than 8mm
  • All measures will be assessed using CBCT.

Exclusion Criteria:

  • Sites needing bone grafting or augmentation.
  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Biologic drilling drilling at low speed

    conventional drilling drilling at high speed

    Arm Description

    Outcomes

    Primary Outcome Measures

    crestal bone loss
    measurement from radiographic analysis using digital periapical x-ray

    Secondary Outcome Measures

    patient morbidity after procedure
    pain value on pain scale
    Implant stability value
    resonance frequency analysis using osstell

    Full Information

    First Posted
    July 15, 2017
    Last Updated
    July 15, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03220815
    Brief Title
    Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group A ) A Randomized Controlled Clinical Trial
    Official Title
    Clinical Evaluation of the Effect of Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla. A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    September 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group) for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low speed (50-70 rpm) without irrigation . In the study group: implant will be inserted in the low speed osteotomy site. • In the control group: implants will be inserted in the conventional prepared osteotomy site. For both groups there is no surgical guide used. The flap will then be copiously irrigated with saline in preparation for closure. The flap will then be closed using interrupted 4/0 resorbable sutures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Resorption

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Biologic drilling drilling at low speed
    Arm Type
    Experimental
    Arm Title
    conventional drilling drilling at high speed
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Drilling at low speed
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional drilling at high speed
    Primary Outcome Measure Information:
    Title
    crestal bone loss
    Description
    measurement from radiographic analysis using digital periapical x-ray
    Time Frame
    [Time Frame: 6 month]
    Secondary Outcome Measure Information:
    Title
    patient morbidity after procedure
    Description
    pain value on pain scale
    Time Frame
    [Time Frame: 1 day]
    Title
    Implant stability value
    Description
    resonance frequency analysis using osstell
    Time Frame
    [Time Frame: 3 month]

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients restoring missing maxillary teeth with implant placement. Both sexes. Age: 25-45 Mesio-distal dimensions: Not less than 6 mm Bone Height: Not less than 12 mm Bucco-lingual dimensions: Not less than 8mm All measures will be assessed using CBCT. Exclusion Criteria: Sites needing bone grafting or augmentation. Heavy smokers more than 20 cigarettes per day. Patients with systemic disease that may affect normal healing.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group A ) A Randomized Controlled Clinical Trial

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