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Prosthetic Complications of Screw Retained Restoration

Primary Purpose

Edentulous Jaw, Edentulous Alveolar Ridge, Edentulous Mouth

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

About this trial

This is an interventional treatment trial for Edentulous Jaw

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

  • Cairo Universty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

titanium bases group

transmucosal abutment group

Arm Description

full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique

a full-arch screw-retained implant prosthesis with transmucosal abutment

Outcomes

Primary Outcome Measures

Abutment screw loosening
Measuring device :Clinical visual inspection / Measuring unit:Binary

Secondary Outcome Measures

Prosthetic screw loosening
Measuring device :Clinical visual inspection / Measuring unit:Binary
Prosthetic screw fracture
Measuring device :Clinical visual inspection / Measuring unit:Binary
Abutment screw fracture
Measuring device :Clinical visual inspection / Measuring unit:Binary
Veneer fracture
Measuring device :Clinical visual inspection / Measuring unit:Binary
Framework fracture
Measuring device :Clinical visual inspection / Measuring unit:Binary
Ti-bases de-cementation
Measuring device :Clinical visual inspection / Measuring unit:Binary

Full Information

First Posted
September 13, 2018
Last Updated
September 14, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03674554
Brief Title
Prosthetic Complications of Screw Retained Restoration
Official Title
Prosthetic Complications of Screw Retained Restoration Using Multi-unit Abutments Versus Intra-oral Luting on Titanium Base in Implant Supported Complete Overdentures Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
July 1, 2020 (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, the investigators 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
Edentulous Jaw, Edentulous Alveolar Ridge, Edentulous Mouth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Allocation sequence generation will be performed by the Senior supervisor. Enrolment of participants will be performed by the principle investigator where the patients will be assessed for eligibility.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
titanium bases group
Arm Type
Experimental
Arm Description
full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique
Arm Title
transmucosal abutment group
Arm Type
Experimental
Arm Description
a full-arch screw-retained implant prosthesis with transmucosal abutment
Intervention Type
Procedure
Intervention Name(s)
titanium bases using intra oral luting cement technique
Intervention Description
a full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique
Intervention Type
Procedure
Intervention Name(s)
transmucosal abutment
Intervention Description
a full-arch screw-retained implant prosthesis with transmucosal abutment
Primary Outcome Measure Information:
Title
Abutment screw loosening
Description
Measuring device :Clinical visual inspection / Measuring unit:Binary
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Prosthetic screw loosening
Description
Measuring device :Clinical visual inspection / Measuring unit:Binary
Time Frame
12 months
Title
Prosthetic screw fracture
Description
Measuring device :Clinical visual inspection / Measuring unit:Binary
Time Frame
12 months
Title
Abutment screw fracture
Description
Measuring device :Clinical visual inspection / Measuring unit:Binary
Time Frame
12 months
Title
Veneer fracture
Description
Measuring device :Clinical visual inspection / Measuring unit:Binary
Time Frame
12 months
Title
Framework fracture
Description
Measuring device :Clinical visual inspection / Measuring unit:Binary
Time Frame
12 months
Title
Ti-bases de-cementation
Description
Measuring device :Clinical visual inspection / Measuring unit:Binary
Time Frame
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
mostafa said hosny, M.Sc. 2018
Phone
0100779234
Ext
002
Email
drdental88@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amr hosny elkadem, phd
Phone
01001162401
Ext
002
Email
amrelkhadem@gmail.com
Facility Information:
Facility Name
Cairo Universty
City
Cairo
ZIP/Postal Code
01234
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mostafa said hosny, M.Sc. 2018
Phone
01007799234
Ext
002
Email
drdental88@gmail.com
First Name & Middle Initial & Last Name & Degree
amr hosny elkhadem, phd
Phone
01001162401
Ext
002
Email
amrelkhadem@gmail.com

12. IPD Sharing Statement

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Prosthetic Complications of Screw Retained Restoration

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