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Clinical Trials/NCT03674554
NCT03674554
Unknown
Not Applicable

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

Cairo University1 site in 1 country30 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Edentulous Jaw
Sponsor
Cairo University
Enrollment
30
Locations
1
Primary Endpoint
Abutment screw loosening
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
July 1, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

mostafa said hosny

Assistant lecturer

Cairo University

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

Outcomes

Primary Outcomes

Abutment screw loosening

Time Frame: 12 months

Measuring device :Clinical visual inspection / Measuring unit:Binary

Secondary Outcomes

  • Abutment screw fracture(12 months)
  • Ti-bases de-cementation(12 months)
  • Prosthetic screw loosening(12 months)
  • Prosthetic screw fracture(12 months)
  • Veneer fracture(12 months)
  • Framework fracture(12 months)

Study Sites (1)

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