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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07005167
Enrollment
54
Registered
2025-06-05
Start date
2025-06-30
Completion date
2027-12-31
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocrown Restoration

Keywords

Hybrid ceramics, cerasmart, HC hard blocks

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.

Interventions

PROCEDUREendocrowns

endocrowns made of HC hard blocks or cerasmart blocks to restore endo treated molars

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
RetentionFrom cementation of endocrown, then at 6 months, 12 months and 18 monthsModified USPHS criteria

Secondary

MeasureTime frameDescription
Marginal AdaptationFrom cementation of endocrown, then at 6 months, 12 months and 18 monthsModified USPHS criteria
Wear of Opposing EnamelFrom cementation of endocrown, then at 6 months, 12 months and 18 monthsDigital software (Geomagic)
Surface TextureFrom cementation of endocrown, then at 6 months, 12 months and 18 monthsModified USPHS criteria
Restoration FailureFrom cementation of endocrown, then at 6 months, 12 months and 18 monthsModified USPHS criteria
Luster of RestorationFrom cementation, then at 6 months, 12 months and 18 monthsModified USPHS criteria
Patient SatisfactionFrom cementation, then at 6 months, 12 months and 18 monthsVAS (Questionnaire)
Color MatchFrom cementation of endocrown, then at 6 months, 12 months and 18 monthsModified USPHS criteria

Countries

Egypt

Contacts

Primary ContactNada Farid Nada Farid Shehab, PhD
nada.farid@dentistry.cu.edu.eg+201223402909
Backup ContactOmnia Omnia Nabil, Lecturer Fixed Prosthodontics
+201222201179

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026