- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03224273
Clinical Assessment of Two Inlay -Retained Bridge Designs
September 10, 2017 updated by: Gomaa soliman, Cairo University
Clinical Assessment of Two Inlay -Retained Bridge Designs (Proximal Box Shaped and Inlay Shaped) in Missing Posterior Teeth Cases
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
70
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 Contact
- Name: Gomaa Abdallah Soliman, MDS
- Phone Number: +201145794545
- Email: gomaasoliman@dentistry.cu.edu.eg
Study Contact Backup
- Name: Mohamed Mahmoud Abdelgawad, MDS
- Phone Number: +201221583708
- Email: mohamed.abdelgawad@dentistry.cu.edu.eg
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
18 years to 51 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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 |
---|---|
Experimental: ( proximal box design)
The proximal box at least ( 1mm wide and has 6◦ divergences, and extend 2 mm apical to the isthmus floor.
|
inlay retained bridge is the less invasive type to restore single missing teeth in the posterior area
Other Names:
|
Active Comparator: ( inlay shaped design)
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
|
inlay retained bridge is the less invasive type to restore single missing teeth in the posterior area
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fracture
Time Frame: 1 year
|
resistance of restoration to disintegrate and the assessment for the outcome will be done by using MUSPHS scale and the measuring unit is score
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
December 1, 2017
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
February 1, 2019
Study Registration Dates
First Submitted
July 18, 2017
First Submitted That Met QC Criteria
July 18, 2017
First Posted (Actual)
July 21, 2017
Study Record Updates
Last Update Posted (Actual)
September 12, 2017
Last Update Submitted That Met QC Criteria
September 10, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2017-07-14
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.
Clinical Trials on Tooth Fractures
-
Tamil Nadu Dr.M.G.R.Medical UniversityRecruiting
-
Centre Hospitalier Universitaire de NīmesCompleted
-
Kimie Bols ØstergaardNot yet recruitingOrthognathic Surgery | Mandibular Fractures | Impacted Third Molar Tooth | OsteotomyDenmark
-
University Hospital, CaenCompletedAnxiety | Tooth AvulsionFrance
-
Shanghai Ninth People's Hospital Affiliated to...Unknown
-
Nanjing First Hospital, Nanjing Medical UniversityCompleted
-
Cairo UniversityUnknown
-
University Medical Center GroningenUnknown
-
University of North Carolina, Chapel HillDentsply InternationalTerminatedTooth Diseases | Tooth Fractures | Tooth InjuriesUnited States
-
Cairo UniversityUnknownTooth Discoloration | Tooth Fractures
Clinical Trials on proximal box inlay retained bridge
-
University Hospital HeidelbergActive, not recruitingUnsatisfactory or Defective Restoration of ToothGermany
-
Peking UniversityRecruitingProximal Gastric Adenocarcinoma | Anastomosis | Adenocarcinoma of Esophagogastric JunctionChina
-
Mansoura UniversityCompletedDental Restoration Failure of Marginal IntegrityEgypt
-
Cairo UniversityUnknown