search
Back to results

Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration

Primary Purpose

Bone Loss

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
titanium bases using intra oral luting cement technique
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Completely edentulous patients
  • Patients with completely edentulous ridges have an opposing natural dentition or implant supported overdenture
  • Completely edentulous patients (with the above mentioned criteria) who have proper amount of attached gingiva (≥2 mm) or to be created
  • Completely edentulous patients (with the above mentioned criteria) who have no history of bruxism
  • Completely edentulous patients (with the above mentioned criteria) who were free or controlled diabetic assessed by measuring glycosylated haemoglobin (HbA1c). (lesser than or equal to 6.4 percent )

Exclusion Criteria:

  • Patients having a medical condition that absolutely contraindicates implant placement.
  • Patients with uncontrolled diabetes, assessed by measuring glycosylated haemoglobin (HbA1c). (greater than to 6.4 percent )
  • Potentially uncooperative patients who are not willing to go through the proposed interventions. - Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day).
  • Patients who are having complete lower denture
  • Patients who have history of bruxism

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Screw retained prosthesis on transmucosal abutments

    Screw retained prosthesis on titanium bases

    Arm Description

    Outcomes

    Primary Outcome Measures

    Crestal bone loss
    measuring crestal bone loss around implants using periapical x ray with parallel technique in millemeters

    Secondary Outcome Measures

    Patients satisfaction
    Numerical Rating Scale (NRS) [11-point ordinal scale from 0 (completely dissatisfied) to 10 (completely satisfied)]

    Full Information

    First Posted
    September 13, 2018
    Last Updated
    October 25, 2018
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03671668
    Brief Title
    Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration
    Official Title
    Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration Using Multi-unit Abutments Versus Intra-oral Luting on Titanium Bases in Implant Supported Complete Overdentures: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2018 (Anticipated)
    Primary Completion Date
    September 1, 2019 (Anticipated)
    Study Completion Date
    September 1, 2019 (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
    On of the main fixed prosthetic options of completely edentulous patients is the screw-retained implant supported prosthesis which was constructed on transmucosal abutments with its encountered problems such as: hardness to make it passively seated with multiple screw fracture and loosening problems and multiple encountered veneer material fracture and so there effect on patient satisfaction with multiple maintenance recalls.so, we want to try a new technique of fabrication which was proposed for reducing the problems of lack of passivity which is the intraoral luting cement technique on titanium bases with reduced screw number but, with luting cement problems as de-cementation and cement biological effects on soft tissues and bone and there effect on number of patient recall visits and maintenance and so there effect on patient satisfaction.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Completely edentulous patients
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Screw retained prosthesis on transmucosal abutments
    Arm Type
    Active Comparator
    Arm Title
    Screw retained prosthesis on titanium bases
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    titanium bases using intra oral luting cement technique
    Intervention Description
    comparing between screw retained prosthesis constructed on transmucosal abutments versus titanium bases in terms of crestal bone loss and patient satisfaction
    Primary Outcome Measure Information:
    Title
    Crestal bone loss
    Description
    measuring crestal bone loss around implants using periapical x ray with parallel technique in millemeters
    Time Frame
    6 to 12 months
    Secondary Outcome Measure Information:
    Title
    Patients satisfaction
    Description
    Numerical Rating Scale (NRS) [11-point ordinal scale from 0 (completely dissatisfied) to 10 (completely satisfied)]
    Time Frame
    6 to 12 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Completely edentulous patients Patients with completely edentulous ridges have an opposing natural dentition or implant supported overdenture Completely edentulous patients (with the above mentioned criteria) who have proper amount of attached gingiva (≥2 mm) or to be created Completely edentulous patients (with the above mentioned criteria) who have no history of bruxism Completely edentulous patients (with the above mentioned criteria) who were free or controlled diabetic assessed by measuring glycosylated haemoglobin (HbA1c). (lesser than or equal to 6.4 percent ) Exclusion Criteria: Patients having a medical condition that absolutely contraindicates implant placement. Patients with uncontrolled diabetes, assessed by measuring glycosylated haemoglobin (HbA1c). (greater than to 6.4 percent ) Potentially uncooperative patients who are not willing to go through the proposed interventions. - Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day). Patients who are having complete lower denture Patients who have history of bruxism
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Saber Ahmed
    Phone
    00201068316376
    Ext
    0020
    Email
    mohamed.saber@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Learn more about this trial

    Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration

    We'll reach out to this number within 24 hrs