Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities

Caries Clinical Trial

Official title:

Randomized Controlled Clinical Trial (RCT) of the New Tooth-colored Restorative Material 'Cention Forte' (Ivoclar Vivadent) vs. 'Equia Forte HT' (GC) in Class-I/II Cavities

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05748327
• Other study ID #: LL4199644
• Secondary ID: S66086
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: April 1, 2028

Study information

• Verified date: March 2024
• Source: Ivoclar Vivadent AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3).

Description:

The primary outcome of the study is the SUCCESS RATE of restorations placed with both filling materials in class I and II cavities after 5 years of clinical service. A failure which leads to repair or replacement of the restoration can have esthetic (marginal staining, loss of anatomical form), functional (i.e. fracture of restoration, loss of retention) or biological reasons (i.e. secondary caries). A restoration is defined as a failure (no success) as soon as at least one FDI criterion is scored as 4 or 5.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject's age between 18 and 65 years old

• Class I and Class II (with a cavity margin 1-1.5 mm from the cusp tip) (caries treatment, removal of existing defective amalgam/composite restorations), on premolars/molars

• Vital teeth

• 2 restorations per patient: both cavities should have comparable size and dimensions

• Presence of neighbour tooth and antagonist (molars with no neighbour tooth at the distal side can also be included)

• Low to moderate caries rate/normal periodontal status with good home care

Exclusion Criteria:

• Hospitalized and medically compromised patients (medical history may not compromise the outcome of the results)

• Pulp exposure or signs of pulpal infection

• No signs of pulpitis or hypersensitivity (Visual analog scale < 3 on biting and temperature sensitivity)

• History of allergy to glass ionomer, acrylate/methacrylate monomers

• Pregnancy

• Chronic disease with oral manifestations or primary oral pathology

• Bad oral hygiene

• High caries rate or periodontal problems

• Absence of antagonists

• Absence of adjacent teeth (except last molar in the row with no neighbour tooth at the distal side)

Related Conditions & MeSH terms

• Caries

Intervention

Device:
• Alcasite restorative material
Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), conditioning with primer, mixing alcasite capsula, place restoration, polymerizing and finishing
• Bulk fill glass hybrid restorative material
Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), mixing bulk fill glass hybrid capsula, conditioning, place restoration, apply coating, polymerizing and finishing

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Ivoclar Vivadent AG	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate	assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Success: Scores equal to/above 3)	5 years
Secondary	Success Rate	assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Success: Scores equal to/above 3)	6 months to 3 years
Secondary	Survival Rate	assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Survival: Score equal to/above 4)	6 months to 5 years
Secondary	Quality criteria (Clinical performance)	assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations	6 months to 5 years