Clinical Performance of Endocrowns Fabricated From Two Hybrid Ceramic Materials on Endodontically Treated Molars: A Randomized Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Endocrown Restoration

• Registration Number: NCT07005167
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Retention	From cementation of endocrown, then at 6 months, 12 months and 18 months	Modified USPHS criteria

Secondary Outcome Measures

Name	Time	Method
Restoration Failure	From cementation of endocrown, then at 6 months, 12 months and 18 months	Modified USPHS criteria
Marginal Adaptation	From cementation of endocrown, then at 6 months, 12 months and 18 months	Modified USPHS criteria
Wear of Opposing Enamel	From cementation of endocrown, then at 6 months, 12 months and 18 months	Digital software (Geomagic)
Surface Texture	From cementation of endocrown, then at 6 months, 12 months and 18 months	Modified USPHS criteria
Color Match	From cementation of endocrown, then at 6 months, 12 months and 18 months	Modified USPHS criteria
Luster of Restoration	From cementation, then at 6 months, 12 months and 18 months	Modified USPHS criteria
Patient Satisfaction	From cementation, then at 6 months, 12 months and 18 months	VAS (Questionnaire)

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt