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Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration

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ClinicalTrials.gov Identifier: NCT03671668
Recruitment Status : Unknown
Verified October 2018 by Mohamed saber mohamed ahmed, South Valley University.
Recruitment status was:  Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed saber mohamed ahmed, South Valley University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bone Loss Other: titanium bases using intra oral luting cement technique Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Completely edentulous patients
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Screw retained prosthesis on transmucosal abutments Other: titanium bases using intra oral luting cement technique
comparing between screw retained prosthesis constructed on transmucosal abutments versus titanium bases in terms of crestal bone loss and patient satisfaction
Experimental: Screw retained prosthesis on titanium bases Other: titanium bases using intra oral luting cement technique
comparing between screw retained prosthesis constructed on transmucosal abutments versus titanium bases in terms of crestal bone loss and patient satisfaction


Outcome Measures
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Primary Outcome Measures :
  1. Crestal bone loss [ Time Frame: 6 to 12 months ]
    measuring crestal bone loss around implants using periapical x ray with parallel technique in millemeters


Secondary Outcome Measures :
  1. Patients satisfaction [ Time Frame: 6 to 12 months ]
    Numerical Rating Scale (NRS) [11-point ordinal scale from 0 (completely dissatisfied) to 10 (completely satisfied)]


Eligibility Criteria
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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
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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): NCT03671668


Contacts
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Contact: Mohamed Saber Ahmed 00201068316376 ext 0020 mohamed.saber@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Mohamed saber mohamed ahmed, Assistant lecturer, South Valley University
ClinicalTrials.gov Identifier: NCT03671668    
Other Study ID Numbers: 28905011809519
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases