One Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays

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

Study Overview

• Status: Not yet recruiting
• Conditions: Tooth Decay
• Intervention / Treatment: Other: onlays conservative; Other: onlays conventional

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Howaida Elhagrasy, M.D.S; Phone Number: 01006890707; Email: howayda.elhagrasy@dentistry.cu.edu.eg
• Study Contact Backup: Name: Eman Hussein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Decayed teeth
2. Teeth restored with defected filling restorations

3. Teeth with occlusal defect 5- Able to return for follow-up examinations and evaluation Exclusion criteria

   1. Patient less than 18 or more than 50 years
   2. Patient with active resistant periodontal diseases
   3. Patients with poor oral hygiene and uncooperative patients
   4. Pregnant women
   5. Patients in the growth stage with partially erupted teeth
   6. Psychiatric problems or unrealistic expectations

   7. Lack of opposing dentition in the area of interest

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: onlays conservative; conservative onlays preparation with partial cusp coverage only defective cusps	Other: onlays conservative; Partial coverage of cusps with shoulder finish line
Active Comparator: onlays conventional; onlays preparation design conventional as all cusps covered with shoulder finish line preparation	Other: onlays conventional; all coverage of cusps as overlay with shoulder finish line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
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)	1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 27, 2022
• Primary Completion (Anticipated): January 15, 2023
• Study Completion (Anticipated): August 12, 2023

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: resala

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No