Clinical trial NCT03674554: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous Jaw
Edentulous Alveolar Ridge
Edentulous Mouth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Abutment screw loosening
timeFrame: 12 months
Secondary outcomes:
measure: Prosthetic screw loosening
timeFrame: 12 months
measure: Prosthetic screw fracture
timeFrame: 12 months
measure: Abutment screw fracture
timeFrame: 12 months
measure: Veneer fracture
timeFrame: 12 months
measure: Framework fracture
timeFrame: 12 months
measure: Ti-bases de-cementation
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo Universty
Study officials:
References: