Back to resultsClinical Assessment of Two Inlay -Retained Bridge Designs
Primary Purpose
Tooth Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
proximal box inlay retained bridge
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Fractures focused on measuring proximal box design preparation
Eligibility Criteria
Inclusion Criteria:
- Absence of periapical or periodontal or diseases
- sound abutment teeth or with small caries or filling on occlusal or proximal surfaces
- Maintenance of good oral hygiene
- No tooth mobility or grade 1 can be accepted
- Sufficient occluso-gingival tooth height (5mm)
- Good alignment of abutment teeth
- mesiodistal edentulous space preferred not exceed 12mm
Exclusion Criteria:
- Patients under the age of 18 or being incapable of taking out a contract
- Patients with any medical condition that impaired correct oral hygiene
- Endodontic ally treated abutment teeth
- a conspicuous medical or psychological history
- bruxism, or known allergic reaction to the materials used
- limited vertical space for the required connector height of 4mm
- pregnant female patients
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
( proximal box design)
( inlay shaped design)
Arm Description
The proximal box at least ( 1mm wide and has 6◦ divergences, and extend 2 mm apical to the isthmus floor.
The occlusal inlay has a preparation depth of 2.0 mm for the ceramic. The occlusal preparation ( 4 mm wide and extend 4mm for premolar and 6 mm for molar mesiodistally
Outcomes
Primary Outcome Measures
fracture
resistance of restoration to disintegrate and the assessment for the outcome will be done by using MUSPHS scale and the measuring unit is score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03224273
Brief Title
Clinical Assessment of Two Inlay -Retained Bridge Designs
Official Title
Clinical Assessment of Two Inlay -Retained Bridge Designs (Proximal Box Shaped and Inlay Shaped) in Missing Posterior Teeth Cases
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
in the last years, dentistry is going to the concept of conservatism to preserve the most amount of tooth structure, so the evolution of new ceramic materials with invasive designs like (inlay- shaped and proximal box shaped) inlay retained bridge, the investigators can restore single missing posterior teeth with less invasive techniques and less rate of restoration fracture.
Detailed Description
It has been demonstrated that a great amount of tooth structure is lost during the prosthetic preparations of abutments for full-coverage FDPs with tooth substance removal of 63% of 73%, this aggressive loss of tooth structure usually accompanied with pain and postoperative sensitivity. In comparison With the inlay-retained bridge, there is less amount of tooth substance loss. this clinical study will provide benefits for practitioners and clinicians by guiding them to choose a more conservative treatment plan with the better marginal fit, clinical performance and satisfaction for the patients on the long term. rather than other benefits like less chair time, less risk for pulp injury, less time and cost
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Fractures
Keywords
proximal box design preparation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
( proximal box design)
Arm Type
Experimental
Arm Description
The proximal box at least ( 1mm wide and has 6◦ divergences, and extend 2 mm apical to the isthmus floor.
Arm Title
( inlay shaped design)
Arm Type
Active Comparator
Arm Description
The occlusal inlay has a preparation depth of 2.0 mm for the ceramic. The occlusal preparation ( 4 mm wide and extend 4mm for premolar and 6 mm for molar mesiodistally
Intervention Type
Other
Intervention Name(s)
proximal box inlay retained bridge
Other Intervention Name(s)
all ceramic inlay retained bridge
Intervention Description
inlay retained bridge is the less invasive type to restore single missing teeth in the posterior area
Primary Outcome Measure Information:
Title
fracture
Description
resistance of restoration to disintegrate and the assessment for the outcome will be done by using MUSPHS scale and the measuring unit is score
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Absence of periapical or periodontal or diseases
sound abutment teeth or with small caries or filling on occlusal or proximal surfaces
Maintenance of good oral hygiene
No tooth mobility or grade 1 can be accepted
Sufficient occluso-gingival tooth height (5mm)
Good alignment of abutment teeth
mesiodistal edentulous space preferred not exceed 12mm
Exclusion Criteria:
Patients under the age of 18 or being incapable of taking out a contract
Patients with any medical condition that impaired correct oral hygiene
Endodontic ally treated abutment teeth
a conspicuous medical or psychological history
bruxism, or known allergic reaction to the materials used
limited vertical space for the required connector height of 4mm
pregnant female patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gomaa Abdallah Soliman, MDS
Phone
+201145794545
Email
gomaasoliman@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Mahmoud Abdelgawad, MDS
Phone
+201221583708
Email
mohamed.abdelgawad@dentistry.cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Clinical Assessment of Two Inlay -Retained Bridge Designs
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