Prosthetic Complications of Screw Retained Restoration

Edentulous Jaw Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03674554
• Other study ID #: 28809010109913
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: September 2018
• Source: Cairo University
• Contact: mostafa said hosny, M.Sc. 2018
• Phone: 0100779234
• Email: drdental88[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Edentulous Jaw
• Edentulous Mouth
• Jaw, Edentulous
• Mouth, Edentulous

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo Universty	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abutment screw loosening	Measuring device :Clinical visual inspection / Measuring unit:Binary	12 months
Secondary	Prosthetic screw loosening	Measuring device :Clinical visual inspection / Measuring unit:Binary	12 months
Secondary	Prosthetic screw fracture	Measuring device :Clinical visual inspection / Measuring unit:Binary	12 months
Secondary	Abutment screw fracture	Measuring device :Clinical visual inspection / Measuring unit:Binary	12 months
Secondary	Veneer fracture	Measuring device :Clinical visual inspection / Measuring unit:Binary	12 months
Secondary	Framework fracture	Measuring device :Clinical visual inspection / Measuring unit:Binary	12 months
Secondary	Ti-bases de-cementation	Measuring device :Clinical visual inspection / Measuring unit:Binary	12 months