- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07756333
Evaluation of Composite Veneers Fabricated by 3D Printing and Milling Technologies
10. august 2026 oppdatert av: youssef alaa
Evaluation of Composite Veneers Fabricated by 3D Printing and Milling Technologies (Randomized Controlled Clinical Trial & In-Vitro Study)
The clinical study aimed to evaluate the clinical performance, color stability, and wear of indirect composite veneers produced using 3D printing and milling technologies.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
A total of fifty-six anterior indirect veneers will be fabricated using 3D printing and milling technologies.
The veneers will be divided into two groups according to the technique of fabrication.
Group I: 28 veneers will be done using 3D printing technology (VarseoSmile TriniQ, Bego), and group II: 28 veneers will be done using milling technology (Cerasmart 270, GC).
Veneer restorations will be fabricated checked, and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year.
Moreover, color stability and surface wear of the restorations will be evaluated in each follow-up session.
Studietype
Intervensjonell
Registrering (Faktiske)
14
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alexandria, Egypt
- Faculty of dentistry, Alexandria university
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Healthy adult patients aged 18 to 45 years.
- Patients requiring veneer restorations due to discoloration, misalignment, tooth malformation or having irregular tooth shape that can be treated without full coverage.
- Patients meeting the criteria for Class I or Class II veneers according to the LeSage veneer classification system.
- Patients requiring veneers restorations on their bilateral maxillary anterior teeth.
- The selected teeth should be vital with absence of clinical signs and symptoms of periapical pathology.
- Patients having a normal occlusal relationship between upper and lower teeth (class I Angle classification).
- Patients capable of tolerating rubber dam applications.
- Patients willing to attend regular follow-up appointments.
Exclusion Criteria:
- Bad oral hygiene (Oral Hygiene Index Simplified >3).
- Non-vital teeth or endodontically treated teeth.
- Severe periodontal disease.
- Patients with para-functional habits (e.g., bruxism, attrition, wear facets).
- Dentin exposure more than 20% of the prepared surface for veneer.
- Prescence of smoking/vaping habits
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Group I: 28 veneers will be done using 3D printing technology (VarseoSmile TriniQ, Bego)
|
A total of fifty-six anterior indirect veneers will be fabricated using 3D printing and milling technologies.
The veneers will be divided into two groups according to the technique of fabrication.
Group I: 28 veneers will be done using 3D printing technology (VarseoSmile TriniQ, Bego), and group II: 28 veneers will be done using milling technology (Cerasmart 270, GC).
Veneer restorations will be fabricated checked, and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year.
Moreover, color stability and surface wear of the restorations will be evaluated in each follow-up session.
|
|
Aktiv komparator: group II: 28 veneers will be done using milling technology (Cerasmart 270, GC)
|
A total of fifty-six anterior indirect veneers will be fabricated using 3D printing and milling technologies.
The veneers will be divided into two groups according to the technique of fabrication.
Group I: 28 veneers will be done using 3D printing technology (VarseoSmile TriniQ, Bego), and group II: 28 veneers will be done using milling technology (Cerasmart 270, GC).
Veneer restorations will be fabricated checked, and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year.
Moreover, color stability and surface wear of the restorations will be evaluated in each follow-up session.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The functional properties of the examined veneer restorations
Tidsramme: 1 year
|
All veneers were assessed clinically at 1 week (baseline) and subsequently at 3, 6, and 12 months, following the FDI evaluation criteria and scoring system, which indicates: Functional properties: (F1) Fracture of material and retention.
(F2) Marginal adaptation.
(F3) Proximal contact point.
(F4) Form and contour.
(F5) Occlusion and wear.
Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), score 3: Clinically satisfactory (CS), score 4: Clinically unsatisfactory (CU), score 5: Clinically poor (PO).
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1 year
|
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The biological properties of the examined veneer restorations
Tidsramme: 1 year
|
All Veneers were assessed clinically at 1 week (baseline) and subsequently at 3, 6, and 12 months, following the revised FDI evaluation criteria and scoring system, which indicates: Biological properties (B1) Caries at restoration margins.
(B2) Dental hard tissue defects at the restoration margin.
(B3) Postoperative hypersensitivity and pulpal status.
Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), Score 3: Clinically satisfactory (CS), Score 4: Clinically unsatisfactory (CU), Score 5: Clinically poor (PO).
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1 year
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The aesthetic properties of the examined veneers
Tidsramme: 1 year
|
All veneers were assessed clinically at 1 week (baseline) and subsequently at 3, 6, and 12 months, following the FDI evaluation criteria and scoring system, which indicates: Aesthetic properties: (A1) Surface luster and surface texture.
(A2) Marginal staining.
(A3) Color match.
Each evaluated property was scored according to the FDI criteria using the following clinical scores: Score 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), Score 3: Clinically satisfactory (CS), Score 4: Clinically unsatisfactory (CU), Score 5: Clinically poor (PO).
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1 year
|
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The color stability of the examined veneers
Tidsramme: 1 year
|
All Veneers were assessed clinically at 1 week (baseline) and subsequently at 3, 6, 9, and 12 months using the vita easy shade spectrophotometer.
The CIEDE2000 formula will be used to measure the color change.
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1 year
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Wear resistance of the examined veneers
Tidsramme: 1 year
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All Veneers were scanned clinically using an intra oral scanner at 1 week (baseline) and subsequently at 3, 6, and 12 months.
The different scans were compared to baseline scan to assess the volume loss and accordingly the wear resistant.
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1 year
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2025
Primær fullføring (Faktiske)
5. august 2026
Studiet fullført (Faktiske)
5. august 2026
Datoer for studieregistrering
Først innsendt
5. august 2026
Først innsendt som oppfylte QC-kriteriene
5. august 2026
Først lagt ut (Faktiske)
10. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 9262109
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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