Prosthetic Complications of Screw Retained Restoration

Not Applicable

• Conditions: Edentulous Alveolar Ridge; Edentulous Mouth; Edentulous Jaw
• Interventions: Procedure: transmucosal abutment; Procedure: titanium bases using intra oral luting cement technique

• Registration Number: NCT03674554
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-14
• Last Update Submitted: 2018-09-14
• Study First Posted: 2018-09-17
• Last Update Posted: 2018-09-17
• Study Start: 2018-10-01
• Primary Completion: 2019-09-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 )

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transmucosal abutment group	transmucosal abutment	a full-arch screw-retained implant prosthesis with transmucosal abutment
titanium bases group	titanium bases using intra oral luting cement technique	full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique

Primary Outcome Measures

Name	Time	Method
Abutment screw loosening	12 months	Measuring device :Clinical visual inspection / Measuring unit:Binary

Secondary Outcome Measures

Name	Time	Method
Ti-bases de-cementation	12 months	Measuring device :Clinical visual inspection / Measuring unit:Binary
Prosthetic screw loosening	12 months	Measuring device :Clinical visual inspection / Measuring unit:Binary
Prosthetic screw fracture	12 months	Measuring device :Clinical visual inspection / Measuring unit:Binary
Abutment screw fracture	12 months	Measuring device :Clinical visual inspection / Measuring unit:Binary
Veneer fracture	12 months	Measuring device :Clinical visual inspection / Measuring unit:Binary
Framework fracture	12 months	Measuring device :Clinical visual inspection / Measuring unit:Binary

Trial Locations

Locations (1)

Cairo Universty; 🇪🇬 Cairo, Egypt