Back to resultsOne Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays
Primary Purpose
Tooth Decay
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
onlays conservative
onlays conventional
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Decay
Eligibility Criteria
Inclusion Criteria:Inclusion criteria:
All subjects are required to be:
1-From 18-50 years old, be able to read and sign the informed consent document. 2- Have no active periodontal or pulpal diseases, have teeth with good restorations 3- Psychologically and physically able to withstand conventional dental procedures 4- Patients with teeth problems indicated for onlay restoration:
- Decayed teeth
- Teeth restored with defected filling restorations
Teeth with occlusal defect 5- Able to return for follow-up examinations and evaluation Exclusion criteria
- Patient less than 18 or more than 50 years
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Pregnant women
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations
Lack of opposing dentition in the area of interest
-
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
onlays conservative
onlays conventional
Arm Description
conservative onlays preparation with partial cusp coverage only defective cusps
onlays preparation design conventional as all cusps covered with shoulder finish line preparation
Outcomes
Primary Outcome Measures
evaluation of fracture resistance
fracture resistance of restorations postoperatively: assessment of the restoration for fracture resistance , by using Measuring device Modified United States Public Health Service (MUSPHS) parameters were used to compare the restorations at baseline and final examination use explorer Measuring unit .Discrete(scores)
alpha no evidence of fracture
bravo evidence of fracture
Secondary Outcome Measures
evaluation of marginal adaptation
marginal adaptation of restorations postoperatively assessment by Measuring device Modified USPHS Criteria Measuring unit .Discrete(scores) use explorer
alpha no visible evidence of ditching along the margin
bravo visible evidence of ditching along the margin not extending to the DE junction
charlie mismatch between restoration and tooth structure within the normal range of color, shade ,translucency
evaluation of patient satisfaction to the onlay restoration through questioning the patient about pain during eating , acceptability ,sensitivity
patient satisfaction of restoration use Questionnaire VAS* Measuring device Measuring unit Numerical(discrete) ('0' unsatisfied-'10' satisfied)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05250232
Brief Title
One Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays
Official Title
One Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 27, 2022 (Anticipated)
Primary Completion Date
January 15, 2023 (Anticipated)
Study Completion Date
August 12, 2023 (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
the aim of present study is to evaluate clinically the fracture liability , marginal adaptation , and patient satisfaction of conservative versus conventional ceramic Onlays use e-max press to restore defective restored molar with old restoration or caries. with one or more cusp defect
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Decay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
onlays conservative
Arm Type
Experimental
Arm Description
conservative onlays preparation with partial cusp coverage only defective cusps
Arm Title
onlays conventional
Arm Type
Active Comparator
Arm Description
onlays preparation design conventional as all cusps covered with shoulder finish line preparation
Intervention Type
Other
Intervention Name(s)
onlays conservative
Intervention Description
Partial coverage of cusps with shoulder finish line
Intervention Type
Other
Intervention Name(s)
onlays conventional
Intervention Description
all coverage of cusps as overlay with shoulder finish line
Primary Outcome Measure Information:
Title
evaluation of fracture resistance
Description
fracture resistance of restorations postoperatively: assessment of the restoration for fracture resistance , by using Measuring device Modified United States Public Health Service (MUSPHS) parameters were used to compare the restorations at baseline and final examination use explorer Measuring unit .Discrete(scores)
alpha no evidence of fracture
bravo evidence of fracture
Time Frame
one year
Secondary Outcome Measure Information:
Title
evaluation of marginal adaptation
Description
marginal adaptation of restorations postoperatively assessment by Measuring device Modified USPHS Criteria Measuring unit .Discrete(scores) use explorer
alpha no visible evidence of ditching along the margin
bravo visible evidence of ditching along the margin not extending to the DE junction
charlie mismatch between restoration and tooth structure within the normal range of color, shade ,translucency
Time Frame
1 year
Title
evaluation of patient satisfaction to the onlay restoration through questioning the patient about pain during eating , acceptability ,sensitivity
Description
patient satisfaction of restoration use Questionnaire VAS* Measuring device Measuring unit Numerical(discrete) ('0' unsatisfied-'10' satisfied)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Inclusion criteria:
All subjects are required to be:
1-From 18-50 years old, be able to read and sign the informed consent document. 2- Have no active periodontal or pulpal diseases, have teeth with good restorations 3- Psychologically and physically able to withstand conventional dental procedures 4- Patients with teeth problems indicated for onlay restoration:
Decayed teeth
Teeth restored with defected filling restorations
Teeth with occlusal defect 5- Able to return for follow-up examinations and evaluation Exclusion criteria
Patient less than 18 or more than 50 years
Patient with active resistant periodontal diseases
Patients with poor oral hygiene and uncooperative patients
Pregnant women
Patients in the growth stage with partially erupted teeth
Psychiatric problems or unrealistic expectations
Lack of opposing dentition in the area of interest
-
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Howaida Elhagrasy, M.D.S
Phone
01006890707
Email
howayda.elhagrasy@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Hussein
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
One Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays
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