- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06695091
Clinical Assessment of Endodontically Treated Posterior Teeth Prepared With Two Occlusal Designs and Two Ceramic Full Coverage Restorations
November 17, 2024 updated by: Sameh Abou-steit, Cairo University
Clinical Assessment of Endodontically Treated Posterior Teeth Prepared With Two Occlusal Designs and Two Ceramic Full Coverage Restorations (Randomized Clinical Trial)
The aim of this study was to assess the impact of flat occlusal preparation design (FOD) of endodontically treated molars on the fracture resistance and distribution of stresses among a ceramic crown-molar structure when compared to two planes occlusal preparation design (TOD).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients with posterior root canal treated teeth that require full coverage restoration.
- 20 - 50 years old.
- Males or Females.
- Good oral hygiene.
- Presence of favorable occlusion and teeth are in normal alignment with the adjacent teeth.
- Patients agreed to return to follow-up evaluation.
Exclusion Criteria:
- Active periodontal or pulpal diseases.
- Lack of opposing dentition.
- Severe medical complications.
- Pregnancy.
- Lack of compliance.
- Evidence of parafunctional habits
- Temporomandibular joint disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Flat occlusal scheme
occlusal design
|
All-ceramic crown
All-ceramic crown
|
|
Active Comparator: Anatomic occlusal scheme
occlusal design
|
All-ceramic crown
All-ceramic crown
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fracture
Time Frame: 12 months
|
Using Modified United States Public Health Service (USPHS) criteria
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal adaptation
Time Frame: 12 months
|
Using Modified United States Public Health Service (USPHS) criteria
|
12 months
|
|
Marginal discoloration
Time Frame: 12 months
|
Using Modified United States Public Health Service (USPHS) criteria
|
12 months
|
|
Secondary caries
Time Frame: 12 months
|
Using Modified United States Public Health Service (USPHS) criteria
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sameh Abou-Steit, Lecturer, Lecturer of Fixed Prosthodontics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Beier US, Kapferer I, Dumfahrt H. Clinical long-term evaluation and failure characteristics of 1,335 all-ceramic restorations. Int J Prosthodont. 2012 Jan-Feb;25(1):70-8.
- Mannocci F, Cowie J. Restoration of endodontically treated teeth. Br Dent J. 2014 Mar;216(6):341-6. doi: 10.1038/sj.bdj.2014.198.
- Varlan C, Dimitriu B, Varlan V, Bodnar D, Suciu I. Current opinions concerning the restoration of endodontically treated teeth: basic principles. J Med Life. 2009 Apr-Jun;2(2):165-72.
- Nagasiri R, Chitmongkolsuk S. Long-term survival of endodontically treated molars without crown coverage: a retrospective cohort study. J Prosthet Dent. 2005 Feb;93(2):164-70. doi: 10.1016/j.prosdent.2004.11.001.
- Oyar P, Ulusoy M, Eskitascioglu G. Finite element analysis of stress distribution in ceramic crowns fabricated with different tooth preparation designs. J Prosthet Dent. 2014 Oct;112(4):871-7. doi: 10.1016/j.prosdent.2013.12.019. Epub 2014 Apr 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 12, 2020
Primary Completion (Estimated)
December 12, 2025
Study Completion (Estimated)
December 12, 2025
Study Registration Dates
First Submitted
November 29, 2022
First Submitted That Met QC Criteria
November 17, 2024
First Posted (Estimated)
November 19, 2024
Study Record Updates
Last Update Posted (Estimated)
November 19, 2024
Last Update Submitted That Met QC Criteria
November 17, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-2020-9-120
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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