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Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol (RCT)

Primary Purpose

Crestal Bone Resorption, Implant Primary Stability, Implant Osseointegration

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
implant site over drilling protocol
Sponsored by
Azhar ALI ELSAYED SELEEM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Crestal Bone Resorption

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who have at least one missing tooth in the upper maxillary arch.
  • Patients with healthy systemic condition.(Brightman. 1994)
  • Patients aged from 20 to 60 years old.
  • Good oral hygiene.(Wiesner et al. 2010)
  • Accepts 9 months follow-up period (cooperative patients)
  • Patient provides an informed consent.

Exclusion Criteria:

  • Patients with signs of acute infection related to the area of interest.
  • Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al. 2006).
  • Current and former smokers (Lambert, Morris, and Ochi 2000)
  • Pregnant women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Conventional-Drilling Tight Fit (Control) group

    Over-drilling Loose Fit (Test) group

    Arm Description

    osteotomy will be achieved with no. 6 round , then widened , using a drill 1 mm larger than the final drill provided by the manufacturer. the final size of the control osteotomies were same diameter of the implant.

    Osteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant.

    Outcomes

    Primary Outcome Measures

    implant stability
    Resonance frequency analysis (RFA) OSSTELL (Osstell Resonance frequency analysis (RFA) (Osstell

    Secondary Outcome Measures

    Crestal bone level
    by Digital radiography

    Full Information

    First Posted
    August 10, 2017
    Last Updated
    August 14, 2017
    Sponsor
    Azhar ALI ELSAYED SELEEM
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03250949
    Brief Title
    Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol
    Acronym
    RCT
    Official Title
    Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol: A Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2017 (Anticipated)
    Primary Completion Date
    January 2018 (Anticipated)
    Study Completion Date
    May 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Azhar ALI ELSAYED SELEEM

    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
    Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol
    Detailed Description
    - Statement of the problem: peri-implant bone is affected by excessive mechanical stress, the mechanism of bone formation is reduced and the bone resorption is increased, leading to MBL. Isidor F. 2006, Warreth A, 009 A drilling sequence using a drill that is smaller than the implant diameter has been applied as a way to obtain enough initial stability.Bilhan H,2010 However, the implant can be extremely compressed or exceed the torque, which can be higher than the elastic limit of bone when a drill that is smaller than the implant diameter is used. This may affect the bone surrounding the implant and may also lead to a micro fracture. Frost mentioned that alveolar bone density is changed by micro deformation due to modification of the physical condition. Bone resorption and fibrous tissue production progress if the micro deformation rate is higher than 3,000 micro strain (με). Also, continuous bone replacement occurs while woven bone appears. Wolff J.1986 Bone tissue adapts to the change of stress while minimizing its weight and transforming its structure. Frost HM,1989 The bone formation mechanism is inhibited and the bone resorption mechanism is enhanced if excessive mechanical stress is applied to alveolar bone during implantation, resulting in the progression of marginal bone loss (MBL). Isidor F.2006 , Warreth A,2009- Rationale for carrying out the trial: Success and survival rate of an implant are directly associated with primary stability. Friberg B,et al 1991 Primary stability is achieved with initial rigid fixation of implants during the surgery and considered necessary for a successful osseointegration. Sennerby L,et al 1992, Rodrigo D,et al 2010 There are two different processes of bone formation at implant sites; contact and distance osteogenesis. Contact osteogenesis infers new bone formation in direct contact with the implant surface. Distance osteogenesis is the new bone formation on the surfaces of the parent bone and occurs when primary stability is absent at implant site. Davies JE.et al 2003, Sivolella S,et al2012 When there is a gap between the implant surface and bone, a clot will fill the space and will be replaced by a provisional connective matrix that will act as scaffold for formation of woven bone. Berglundh T,et al,2003 , Rossi F,2012 Our study will evaluate the effect of oversized drilling on implant success and secondary stability

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crestal Bone Resorption, Implant Primary Stability, Implant Osseointegration

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional-Drilling Tight Fit (Control) group
    Arm Type
    No Intervention
    Arm Description
    osteotomy will be achieved with no. 6 round , then widened , using a drill 1 mm larger than the final drill provided by the manufacturer. the final size of the control osteotomies were same diameter of the implant.
    Arm Title
    Over-drilling Loose Fit (Test) group
    Arm Type
    Experimental
    Arm Description
    Osteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant.
    Intervention Type
    Procedure
    Intervention Name(s)
    implant site over drilling protocol
    Other Intervention Name(s)
    NEO biotech implant system
    Intervention Description
    Osteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant. osteotomy site of the implant is wider by 0.2mm than the implant diameter
    Primary Outcome Measure Information:
    Title
    implant stability
    Description
    Resonance frequency analysis (RFA) OSSTELL (Osstell Resonance frequency analysis (RFA) (Osstell
    Time Frame
    first 3 months
    Secondary Outcome Measure Information:
    Title
    Crestal bone level
    Description
    by Digital radiography
    Time Frame
    from 3 to 6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who have at least one missing tooth in the upper maxillary arch. Patients with healthy systemic condition.(Brightman. 1994) Patients aged from 20 to 60 years old. Good oral hygiene.(Wiesner et al. 2010) Accepts 9 months follow-up period (cooperative patients) Patient provides an informed consent. Exclusion Criteria: Patients with signs of acute infection related to the area of interest. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al. 2006). Current and former smokers (Lambert, Morris, and Ochi 2000) Pregnant women

    12. IPD Sharing Statement

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