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Assessment Of Inlay Retained Bridge Designs In Missing Posterior Teeth Cases. (Randomized Clinical Trial)

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ClinicalTrials.gov Identifier: NCT03139396
Recruitment Status : Not yet recruiting
First Posted : May 4, 2017
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Mahmoud Abdelgawad, Cairo University

Brief Summary:
Patients with missing back teeth can be restored with an inlay retained bridge.The inlay retained bridge designs include inlay shaped, tub shaped or proximal box shaped.In this study a clinical evaluation will be commenced to evaluate two designs the inlay shaped and the tub shaped.The hypothesis of our trial is that the new design may show longer survival rate due to less stress applied on the restoration which allow the restoration to function for longer period as the inlay shaped bridge showed clinical problems during survice.

Condition or disease Intervention/treatment Phase
Tooth Loss Procedure: tub shaped inlay bridge design Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Assessment Of Inlay Retained Bridge Designs (Tub Shaped And Inlay Shaped) In Missing Posterior Teeth Cases. (Randomized Clinical Trial)
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Active Comparator: inlay shaped inlay bridge design
The inlay shaped inlay bridge design preparation show three types of preparation, the inlay shaped, the tub shaped inlay bridge design and the proximal box shaped designs. Intracoronal preparation of the inlay retained prosthesis for the abutments (inlay shaped and tub shaped) should show the following criteria: The inlay shaped preparation should show an occlusal-proximal box preparation and to be designed with the line angles should be rounded, smooth and rounded corners, and rectangular flat floor with no beveling for the occlusal and gingival margins. The occlusal inlay preparation should have preparation depth allowed for a thickness of 2.0 mm for the material of the bridge. The occlusal reduction show 4 mm width with extension of 4 or 6 mm mesio distally for the posterior teeth.
Procedure: tub shaped inlay bridge design
inlay retained bridge with tub shaped retainer on both abutments
Other Name: tub shaped

Experimental: tub shaped inlay bridge design
The tub-shaped reduction consist of an occlusal proximal inlay and prepared as the same geometry as the inlay shaped preparation, except that for the proximal box preparation which is not present in this preparation design.
Procedure: tub shaped inlay bridge design
inlay retained bridge with tub shaped retainer on both abutments
Other Name: tub shaped




Primary Outcome Measures :
  1. Retention [ Time Frame: 1 year ]
    assess the loss of the restoration (debonding) the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)


Secondary Outcome Measures :
  1. marginal adaptation [ Time Frame: 1 year ]
    assess the fitting of the restoration on the underlying tooth the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)

  2. Caries [ Time Frame: 1 year ]
    assess if decay occurred on the abutment teeth the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)

  3. gingivitis [ Time Frame: 1 year ]
    assess if the gum aroung the teeth is inflamed the scale that will be used is the Gingival index scale and the measuring unit is score (discrete)

  4. fracture [ Time Frame: 1 year ]
    assess if cracks or fracture occurred to the restoration the scale that will be used is the MUSPHS scale and the measuring unit is score (discrete)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. From 18-55 years old, should be able to read and sign the consent document.
  2. Ability to tolerate the restorative procedures (physical and psychological).
  3. Patients with teeth problems indicated for inlay retained fixed partial denture:

    1. Good oral hygiene
    2. Low susceptibility to decay
    3. Have a minimum coronal tooth height of 5 mm,
    4. Parallel abutments
    5. Sufficient mesio distal edentulous gap dimensions.
  4. With no active periodontal or pulpal problems, with sound teeth or teeth with shallow restorations
  5. Willing to return for follow-up visits.

Exclusion Criteria:

  1. Partially erupted teeth (young)
  2. Bad oral hygiene and motivation
  3. Root canal treated teeth
  4. Psychiatric problems or unrealistic expectations
  5. Severe parafunctional habits
  6. The absence of enamel on the preparation margins
  7. Extensive crown defects
  8. Abutment mobility

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): NCT03139396


Contacts
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Contact: Mohamed Mahmoud Abdelfattah, MDS 00201221583708 mohamed.abdelgawad@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: Mohamed Mahmoud Abdelgawad, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03139396     History of Changes
Other Study ID Numbers: CEBD-CU-2017-04-16
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Mahmoud Abdelgawad, Cairo University:
inlay bridge, tub shaped design

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases