Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration

Study Overview
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Brief Summary
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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, we 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.

Official Title
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Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration Using Multi-unit Abutments Versus Intra-oral Luting on Titanium Bases in Implant Supported Complete Overdentures: A Randomized Clinical Trial

Conditions
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Bone Loss

Intervention / Treatment
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* Other: titanium bases using intra oral luting cement technique


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Completely edentulous patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Screw retained prosthesis on transmucosal abutments<br> | Other: titanium bases using intra oral luting cement technique<br>* comparing between screw retained prosthesis constructed on transmucosal abutments versus titanium bases in terms of crestal bone loss and patient satisfaction<br>|
| Experimental: Screw retained prosthesis on titanium bases<br> | Other: titanium bases using intra oral luting cement technique<br>* comparing between screw retained prosthesis constructed on transmucosal abutments versus titanium bases in terms of crestal bone loss and patient satisfaction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crestal bone loss | measuring crestal bone loss around implants using periapical x ray with parallel technique in millemeters | 6 to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients satisfaction | Numerical Rating Scale (NRS) [11-point ordinal scale from 0 (completely dissatisfied) to 10 (completely satisfied)] | 6 to 12 months |