NCT07005167Not yet recruitingNot Applicable
Clinical Performance of Endocrowns Fabricated From Two Hybrid Ceramic Materials on Endodontically Treated Molars: A Randomized Clinical Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Retention
Study Overview
Brief Summary
The goal of this study is to evaluate the clinical success rate (measured by retention) of endo-crowns fabricated from two hybrid ceramic materials (HC Hard blocks ) versus (Cerasmart) at 6, 12, and 18 months.
Secondary Objectives are:
- To compare the incidence of restoration failures between the two materials
- To assess marginal adaptation and marginal discoloration over time
- To evaluate wear of opposing enamel quantitatively
- To compare surface texture, color match, and luster between materials
- To determine patient satisfaction with both types of restorations It will be a randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥21 years
- •Good general health (ASA I or II)
- •Willing and able to provide informed consent
- •Committed to follow-up appointments for 18 months
- •Root canal treated molars requiring restoration
- •Adequate remaining tooth structure:
- •Minimum 2mm ferrule height
- •Sufficient wall thickness (≥1.5mm)
- •At least 2 remaining walls
- •Opposing natural dentition or fixed prosthesis
- •Adequate periodontal health:
- •Probing depth ≤4mm
- •No bleeding on probing
- •Good oral hygiene with plaque score ≤20%
- •Sufficient mouth opening for clinical procedures
- •Normal occlusion and acceptable interocclusal space
Exclusion Criteria
- •Pregnant or lactating women
- •Severe bruxism or parafunctional habits
- •Active periodontal disease
- •Active caries or inadequate oral hygiene
- •Less than 2mm ferrule height after preparation
- •Apical pathology or inadequate root canal treatment
- •Tooth mobility grade II or III
- •Known allergy to materials used
- •Uncontrolled diabetes (HbA1c >7.0%)
- •Radiation therapy in head and neck region
- •Temporomandibular joint disorders
- •History of poor compliance with dental appointments
- •Heavy smokers (>10 cigarettes/day)
- •Chronic use of medications affecting salivary flow
- •Unable to understand study requirements
- •Evidence of pulpal or periapical pathology
Arms & Interventions
utpatients with endo-treated molars that will be restored with Cerasmart endocrowns
Active Comparator
Intervention: endocrowns (Procedure)
Outpatients with endo-treated molars that will be restored with HC hard hybrid ceramic endocrowns
Experimental
Intervention: endocrowns (Procedure)
Outcomes
Primary Outcomes
Retention
Time Frame: From cementation of endocrown, then at 6 months, 12 months and 18 months
Modified USPHS criteria
Secondary Outcomes
- Marginal Adaptation(From cementation of endocrown, then at 6 months, 12 months and 18 months)
- Wear of Opposing Enamel(From cementation of endocrown, then at 6 months, 12 months and 18 months)
- Surface Texture(From cementation of endocrown, then at 6 months, 12 months and 18 months)
- Color Match(From cementation of endocrown, then at 6 months, 12 months and 18 months)
- Luster of Restoration(From cementation, then at 6 months, 12 months and 18 months)
- Patient Satisfaction(From cementation, then at 6 months, 12 months and 18 months)
- Restoration Failure(From cementation of endocrown, then at 6 months, 12 months and 18 months)
Investigators
Nada Ahmed Farid Zaki Shehab
Lecturer
Cairo University
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Clinical Performance of 3D-Printed vs. Milled EndocrownsGross Material Loss in Endodontically Treated Upper and Lower MolarsNo Systemic InfectionGingival Steps Should be at Gum LevelNCT06850649Gulcan COSKUN AKAR33
Completed
Not Applicable
Post root canal treatment restoration - Comparison between endocrown and fiber post crowCTRI/2019/04/018848I72
Completed
Not Applicable
Clinical Evaluation of Endocrown and Overlay RestorationsClinical Performance of Endodontically Treated Teeth Restored With Endocrowns and OverlaysNCT06734806TC Erciyes University39
Recruiting
Not Applicable
Digital, Conventional, And Biomimetic Approaches for Restoring Endodontically Treated TeethEndodontically Treated TeethNCT06717230October University for Modern Sciences and Arts42
Active, not recruiting
Not Applicable
A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different MaterialsEndodontically Treated TeethNCT06311422Hacettepe University74
