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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03674554
Enrollment
30
Registered
2018-09-17
Start date
2018-10-01
Completion date
2020-07-01
Last updated
2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Alveolar Ridge, Edentulous Jaw, Edentulous Mouth

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

Interventions

a full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique

PROCEDUREtransmucosal abutment

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Allocation sequence generation will be performed by the Senior supervisor. Enrolment of participants will be performed by the principle investigator where the patients will be assessed for eligibility.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Abutment screw loosening12 monthsMeasuring device :Clinical visual inspection / Measuring unit:Binary

Secondary

MeasureTime frameDescription
Prosthetic screw fracture12 monthsMeasuring device :Clinical visual inspection / Measuring unit:Binary
Abutment screw fracture12 monthsMeasuring device :Clinical visual inspection / Measuring unit:Binary
Prosthetic screw loosening12 monthsMeasuring device :Clinical visual inspection / Measuring unit:Binary
Framework fracture12 monthsMeasuring device :Clinical visual inspection / Measuring unit:Binary
Ti-bases de-cementation12 monthsMeasuring device :Clinical visual inspection / Measuring unit:Binary
Veneer fracture12 monthsMeasuring device :Clinical visual inspection / Measuring unit:Binary

Countries

Egypt

Contacts

Primary Contactmostafa said hosny, M.Sc. 2018
drdental88@gmail.com0100779234
Backup ContactAmr hosny elkadem, phd
amrelkhadem@gmail.com01001162401

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026