Clinical trial NCT07005167: Clinical Performance of Endocrowns Fabricated From Two Hybrid Ceramic Materials on Endodontically Treated Molars:
        A Randomized Clinical Trial
Official title: Clinical Performance of Endocrowns Fabricated From Two Hybrid Ceramic Materials on Endodontically Treated Molars:
        A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endocrown Restoration
Keywords: Hybrid ceramics
cerasmart
HC hard blocks
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.
Primary purpose: TREATMENT

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:

1. To compare the incidence of restoration failures between the two materials
2. To assess marginal adaptation and marginal discoloration over time
3. To evaluate wear of opposing enamel quantitatively
4. To compare surface texture, color match, and luster between materials
5. To determine patient satisfaction with both types of restorations It will be a randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.


Eligibility criteria: Inclusion Criteria:

1. Age ≥21 years
2. Good general health (ASA I or II)
3. Willing and able to provide informed consent
4. Committed to follow-up appointments for 18 months
5. Root canal treated molars requiring restoration
6. Adequate remaining tooth structure:

   * Minimum 2mm ferrule height
   * Sufficient wall thickness (≥1.5mm)
   * At least 2 remaining walls
7. Opposing natural dentition or fixed prosthesis
8. Adequate periodontal health:

   * Probing depth ≤4mm
   * No bleeding on probing
9. Good oral hygiene with plaque score ≤20%
10. Sufficient mouth opening for clinical procedures
11. Normal occlusion and acceptable interocclusal space

Exclusion Criteria:

1. Pregnant or lactating women
2. Severe bruxism or parafunctional habits
3. Active periodontal disease
4. Active caries or inadequate oral hygiene
5. Less than 2mm ferrule height after preparation
6. Apical pathology or inadequate root canal treatment
7. Tooth mobility grade II or III
8. Known allergy to materials used
9. Uncontrolled diabetes (HbA1c \>7.0%)
10. Radiation therapy in head and neck region
11. Temporomandibular joint disorders
12. History of poor compliance with dental appointments
13. Heavy smokers (\>10 cigarettes/day)
14. Chronic use of medications affecting salivary flow
15. Unable to understand study requirements
16. Evidence of pulpal or periapical pathology

Primary outcomes:
measure: Retention
timeFrame: From cementation of endocrown, then at 6 months, 12 months and 18 months
Secondary outcomes:
measure: Restoration Failure
timeFrame: From cementation of endocrown, then at 6 months, 12 months and 18 months
measure: Marginal Adaptation
timeFrame: From cementation of endocrown, then at 6 months, 12 months and 18 months
measure: Wear of Opposing Enamel
timeFrame: From cementation of endocrown, then at 6 months, 12 months and 18 months
measure: Surface Texture
timeFrame: From cementation of endocrown, then at 6 months, 12 months and 18 months
measure: Color Match
timeFrame: From cementation of endocrown, then at 6 months, 12 months and 18 months
measure: Luster of Restoration
timeFrame: From cementation, then at 6 months, 12 months and 18 months
measure: Patient Satisfaction
timeFrame: From cementation, then at 6 months, 12 months and 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References: