Prosthetic Complications of Screw Retained Restoration

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

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

Study Overview

• Status: Unknown
• Conditions: Edentulous Alveolar Ridge; Edentulous Jaw; Edentulous Mouth
• Intervention / Treatment: Procedure: titanium bases using intra oral luting cement technique; Procedure: transmucosal abutment

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mostafa said hosny, M.Sc. 2018; Phone Number: 002 0100779234; Email: drdental88@gmail.com
• Study Contact Backup: Name: Amr hosny elkadem, phd; Phone Number: 002 01001162401; Email: amrelkhadem@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 01234
    • Cairo Universty
    • Contact: mostafa said hosny, M.Sc. 2018; Phone Number: 002 01007799234; Email: drdental88@gmail.com
    • Contact: amr hosny elkhadem, phd; Phone Number: 002 01001162401; Email: amrelkhadem@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: titanium bases group; full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique	Procedure: titanium bases using intra oral luting cement technique; a full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique
Experimental: transmucosal abutment group; a full-arch screw-retained implant prosthesis with transmucosal abutment	Procedure: transmucosal abutment; a full-arch screw-retained implant prosthesis with transmucosal abutment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abutment screw loosening	Measuring device :Clinical visual inspection / Measuring unit:Binary	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: 28809010109913

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No