- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07614451
This Study is Conducted to Evaluate the Clinical Performance of Indirect Overlay Restorations With Different Cavity Preparation Designs in Endodontically Treated Molars.
A Prospective Clinical Evaluation of Indirect Overlay Restorations With Different Cavity Preparation Designs in Endodontically Treated Molars: Two Year Randomized Clinical Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
First Validation of endodontic treatment using a periapical radiograph and proper history taking.
{I}• Cavity Preparation Procedures for Comparator Group:
- Removal of any remnants of temporary filling and excess gutta percha to the level of root canal orifice.
- Removal of all undermined enamel.
- Then 1.5 to 2 mm cusp reduction will be performed for the buccal and lingual walls.
- The occlusal box will be of 2.5 mm width, 2 mm depth cavity walls and will be flared to produce a 6 degree of divergence.
- The cavity will have internal rounded angles, finished enamel with sharp non-beveled margins and smooth well-defined walls.
- Immediate Dentin Sealing and Cavity Optimization: Immediate dentin sealing will be performed through the use of a universal adhesive followed by the injection of injectable flowable resin composite. Blocking of undercuts using injectable flowable resin composite and margin elevation if required.
- The final retentive design will include occlusal clearance of 2 mm with occlusal box cavity of depth 2 mm with all margins in enamel occlusally and all dentin surfaces will be covered.
{II}• Cavity Preparation Procedures for Intervention Group:
- Removal of any remnants of temporary filling and excess gutta percha to the level of root canal orifice.
- No additional removal of the tooth structure will be performed at this step.
- Cavity optimization will be performed first.
- Blocking of undercuts using injectable flowable resin composite and margin elevation if required.
- The occlusal cavity will be restored during cavity optimization with injectable resin composite to reduce the areas of dentin exposure and preserve the remaining tooth structure.
- The dentin substitute resin composite will establish the biobase.
- An anatomical non retentive preparation design will be performed to show continuous inclined plane preparation with 2 mm cuspal reduction, concave chamfer margins, and 1 to 1.5 mm thick butt-joint preparation in the interproximal portion.
The final cavity design will include occlusal clearance of 2 mm with total cusp coverage, with biomimetic features (anatomical, non-retentive design) with no occlusal box cavity.
- The CAD/CAM partial coverage overlay restoration will be designed, then milled using SHOFU Hard hybrid ceramic blocks for both groups following its design.
- Cementation for both groups:
- Selective etching of the enamel margins of the cavity will be made using 37% phosphoric acid.
- Application of Universal Adhesive according to manufacturer's instructions and cured.
- Regarding the milled indirect overlay restorations; surface roughening with Dura-Green Stones SHOFU will be performed, followed by the application of a suitable priming agent, then the injection of resin cement in the fitting surface, and finally the restoration will be cemented.
- Restoration will be placed onto the prepared cavities allowing for excess resin cement to emerge which will then be tac-cured for 5 second using a standard intensity light cure allowing for slight hardening of the excess resin cement.
- Removal of excess cement using a sharp explorer, excavator or a c-blade along with the use of interdental flossing to ensure elimination of interdental excess resin cement material.
- Completing the remaining curing cycle after excess removal to the full curing time.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Sara Ibrahim Fahmy, PhD
- Numero di telefono: 002 01006256086
- Email: sara.fahmy@dentistry.cu.edu.eg
Backup dei contatti dello studio
- Nome: Aya Mohamed Adly, Lecturer
- Email: aya.mohamed@dentistry.cu.edu.eg
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
Patient Related Criteria:
- Adult patients (age: 20-60 years) of both genders.
- Healthy patients (not suffering of any systematic or chronic diseases).
- Able to tolerate the necessary restorative procedures.
- Willing to sign the informed ethical consent.
- Accepts the follow-up period.
Tooth Related Criteria:
- Proper endodontically treated teeth.
- First and second permanent molars.
- Absence of any peri-apical lesions.
- Absence of any periodontal disease involvement.
- Large access cavities with one or two missing walls.
- Patients with proper oral hygiene.
- Presence of opposing tooth.
Exclusion Criteria:
- Patient related:
- Patients younger than 20 or older than 60 years old.
- Pregnant females.
- Patients with any systemic or chronic diseases.
- Patients not accepting the follow-up period.
- Patients not willing to sign the informed ethical consent.
- Patients with known allergies to latex and/or resinous material.
Tooth related
- Endodontically treated anterior, premolar and third molar teeth.
- Hopelessly carious/destructed teeth necessitating extraction.
- Mobile teeth, indicating periodontal disease or trauma.
- External or internal resorption.
- Poor endodontic treatment.
- Periapical lesion present.
- Cervical carious lesions involved.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: conventional retentive overlay design
|
Endodontically treated molars will receive indirect overlay restorations utilizing a conventional retentive occlusal box cavity design.
|
|
Sperimentale: minimal invasive non-retentive overlay design
|
Endodontically treated molars will receive indirect overlay restorations utilizing a minimal invasive anatomical non-retentive design.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Marginal adaptation (success rate)
Lasso di tempo: T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years
|
Measuring device: Modified FDI criteria, Measuring unit: Ordinal Data (scores) |
T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
proximal contact point 3.fracture of material and retention 4.wear 5. marginal staining 6. color match 7.caries at restoration margin
Lasso di tempo: T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years
|
Measuring device: Modified FDI criteria, Measuring unit: Ordinal Data (scores) |
T0: baseline T1: 6 months T2: 12 months T3: 18 months T4: 2 years
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Olfat ElSayed Hassanein, Professor, Conservative Dentistry, Faculty of Dentistry, Cairo University
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Primo Inserito (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 12041994
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