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Satisfaction and Adaptation After Elevation of Vertical Dimension of Occlusion Using Overlay Denture or Fixed Crowns

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. Identifier: NCT03579134
Recruitment Status : Unknown
Verified June 2018 by Amr Elkammah, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Information provided by (Responsible Party):
Amr Elkammah, Cairo University

Brief Summary:
Elevation of the vertical dimension of occlusion has always been a debatable issue specially using removable prosthesis. Fixed restorations have been a more predictable treatment modality in treating patients with tooth surface loss. A more conservative restoration, more retrievable, and cost effective option is proposed. Partial overlay dentures could provide a reversible and more conservative solution either by being used as a final restoration or teeth are provided with ceramic onlays instead of crowns.

Condition or disease Intervention/treatment Phase
Patient Satisfaction Device: partial overlay denture Other: fixed temporary crowns Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Evaluation of Patient Satisfaction and Adaptation After Elevation of Vertical Dimension of Occlusion in Patients With Compensated Tooth Surface Loss Using Partial Overlay Denture or Fixed Temporary Crowns
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Experimental: partial overlay denture
removable partial denture with a metal extension over the remaining posterior teeth raising their height to the newly proposed vertical dimension and occlusal plane
Device: partial overlay denture
removable appliance similar to a removable partial denture but with overlay occluslal rests covering the full occlusal surface of the remaining posterior teeth

Active Comparator: fixed temporary crowns
fixed crowns made from temporary material placed on the prepared posterior teeth to the new occlusal plane level elevating the vertical dimension to the newly proposed level
Other: fixed temporary crowns
fixed crowns made from temporary material placed to the newly altered vertical dimension

Primary Outcome Measures :
  1. Assesment of patient satisfaction using OHIP-14 questionnaire [ Time Frame: 3 months ]
    comfort of the patient and satisfaction regarding function, speech, esthetics are assesed using OHIP-14 questionnaire, and assesment will be using a Likert scale. The Likert Scale is a 5 or 7 point scale that offers a range of answer options - from one extreme attitude to another, like "extremely likely" to "not at all likely." Typically, they include a moderate or neutral midpoint.

Secondary Outcome Measures :
  1. adaptation [ Time Frame: 3 months ]
    absence of any appearing symptoms associated with elevating the vertical dimension of occlusion

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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients fully dentate or partially edentulous with medium to severe tooth surface loss
  • Minimum of one existing occluding pair of posterior teeth on each side (right and left).
  • Patients were class 1 skeletal relation Patients requiring elevation 2-5mm.
  • Patients having compensated tooth surface loss

Exclusion Criteria:

  • Patients not having atleast 2 occluding pairs of posterior teeth.
  • Skeletal class 2 and 3.
  • Edentulous patients

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 identifier (NCT number): NCT03579134

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Contact: Amr H Elkammah, B.D.S 01001688382 ext +2

Sponsors and Collaborators
Cairo University
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Principal Investigator: Amr H Elkammah, B.D.S Cairo University
Study Director: Ahmed E Fayyad, P.H.D Cairo University
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Responsible Party: Amr Elkammah, Principal inverstigator, Cairo University Identifier: NCT03579134    
Other Study ID Numbers: amrelkammah
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all collected IPD
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 6 months after publication
Access Criteria: the use of a controlled access approach, using a transparent and robust system to review requests and provide secure data access, seeking consent for sharing IPD from participants with adequate assurance that patient privacy and confidentiality can be maintained; and establishing an approach to resource the sharing of IPD

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