Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration
1 other identifier
interventional
30
0 countries
N/A
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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2018
CompletedFirst Posted
Study publicly available on registry
September 14, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedOctober 26, 2018
October 1, 2018
10 months
September 13, 2018
October 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Crestal bone loss
measuring crestal bone loss around implants using periapical x ray with parallel technique in millemeters
6 to 12 months
Secondary Outcomes (1)
Patients satisfaction
6 to 12 months
Study Arms (2)
Screw retained prosthesis on transmucosal abutments
ACTIVE COMPARATORScrew retained prosthesis on titanium bases
EXPERIMENTALInterventions
comparing between screw retained prosthesis constructed on transmucosal abutments versus titanium bases in terms of crestal bone loss and patient satisfaction
Eligibility Criteria
You may qualify if:
- 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 )
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
September 13, 2018
First Posted
September 14, 2018
Study Start
November 1, 2018
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
October 26, 2018
Record last verified: 2018-10