- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07756333
Evaluation of Composite Veneers Fabricated by 3D Printing and Milling Technologies
10. august 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
14
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Alexandria, Egypten
- Faculty of dentistry, Alexandria university
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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).
|
1 year
|
|
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).
|
1 year
|
|
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).
|
1 year
|
|
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.
|
1 year
|
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Wear resistance of the examined veneers
Tidsramme: 1 year
|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2025
Primær færdiggørelse (Faktiske)
5. august 2026
Studieafslutning (Faktiske)
5. august 2026
Datoer for studieregistrering
Først indsendt
5. august 2026
Først indsendt, der opfyldte QC-kriterier
5. august 2026
Først opslået (Faktiske)
10. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 9262109
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