Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prosthetic Complications of Screw Retained Restoration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674554
Recruitment Status : Unknown
Verified September 2018 by mostafa said hosny, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
mostafa said hosny, Cairo University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Edentulous Jaw Edentulous Alveolar Ridge Edentulous Mouth Procedure: titanium bases using intra oral luting cement technique Procedure: transmucosal abutment Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Primary Purpose: Treatment
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
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : July 1, 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: titanium bases group
full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique
 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
Experimental: transmucosal abutment group
a full-arch screw-retained implant prosthesis with transmucosal abutment
 Procedure: transmucosal abutment
a full-arch screw-retained implant prosthesis with transmucosal abutment


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Abutment screw loosening [ Time Frame: 12 months ]
    Measuring device :Clinical visual inspection / Measuring unit:Binary


Secondary Outcome Measures :
  1. Prosthetic screw loosening [ Time Frame: 12 months ]
    Measuring device :Clinical visual inspection / Measuring unit:Binary

  2. Prosthetic screw fracture [ Time Frame: 12 months ]
    Measuring device :Clinical visual inspection / Measuring unit:Binary

  3. Abutment screw fracture [ Time Frame: 12 months ]
    Measuring device :Clinical visual inspection / Measuring unit:Binary

  4. Veneer fracture [ Time Frame: 12 months ]
    Measuring device :Clinical visual inspection / Measuring unit:Binary

  5. Framework fracture [ Time Frame: 12 months ]
    Measuring device :Clinical visual inspection / Measuring unit:Binary

  6. Ti-bases de-cementation [ Time Frame: 12 months ]
    Measuring device :Clinical visual inspection / Measuring unit:Binary


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674554


Contacts
Layout table for location contacts
Contact: mostafa said hosny, M.Sc. 2018 0100779234 ext 002 drdental88@gmail.com
Contact: Amr hosny elkadem, phd 01001162401 ext 002 amrelkhadem@gmail.com

Locations
Layout table for location information
Egypt
Cairo Universty
Cairo, Egypt, 01234
Contact: mostafa said hosny, M.Sc. 2018    01007799234 ext 002    drdental88@gmail.com   
Contact: amr hosny elkhadem, phd    01001162401 ext 002    amrelkhadem@gmail.com   
Sponsors and Collaborators
Cairo University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: mostafa said hosny, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03674554    
Other Study ID Numbers: 28809010109913
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Jaw, Edentulous
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
 Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases