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

• Sponsor: Ivoclar Vivadent AG (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05748327
• Collaborator: KU Leuven (Other)
• Enrollment: 58
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 64.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Caries; Defective Restorations	Device: Alcasite restorative material; Device: Bulk fill glass hybrid restorative material	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Split-Mouth DesignSplit-Mouth Design
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 22, 2022
• Anticipated Primary Completion Date: Apr 1, 2028
• Anticipated Study Completion Date: Apr 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alcasite restorative material	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
Active Comparator: Bulk fill glass hybrid restorative material	Device: 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

Outcome Measures

Primary Outcome Measures

1. Success Rate [5 years]

   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)

Secondary Outcome Measures

1. Success Rate [6 months to 3 years]

   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)

2. Survival Rate [6 months to 5 years]

   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)

3. Quality criteria (Clinical performance) [6 months to 5 years]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KU Leuven	Leuven		Belgium

Sponsors and Collaborators

• Ivoclar Vivadent AG
• KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ivoclar Vivadent AG
• ClinicalTrials.gov Identifier: NCT05748327
• Other Study ID Numbers: LL4199644; S66086
• First Posted: Feb 28, 2023
• Last Update Posted: Feb 28, 2023
• Last Verified: Nov 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Feb 28, 2023