Contemporary Restorative Materials in Primary Molars

NCT ID: NCT06544486

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2024-07-19

Brief Summary

This randomized controlled trial aims to compare the clinical effectiveness of four ion-releasing restorative materials in the proximal cavities of primary molars that underwent selective caries removal. The main questions to answer are:

• Will there be any difference among the restorative materials clinical succes in the means of modified United States Public Health Services (USPHS) criteria for dental restorations?
• Will there be any difference among the restorative materials in the means of preservation of pulpal vitality? Eighty six children (262 teeth), between 5 and 9 years old (7.15±1.14) enrolled for the study. Researchers will compare the clinical performance of restorative materials, (1:Equia Forte HT; 2: Fuji II LC; 3: Cention N; 4: ChemFil Rock), applied to the proximal cavities of primary molars following selective caries removal, according to the modified USPHS criteria.

Participants will:

• visit the clinic 1st,3rd,6th,12th,18th,24th,30th and 36th months after the restoration.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Device: Hybrid Glass-ionomer Cement (Equia Forte HT)

The material in capsule form was placed in the mixer (Ultramat 2, SDI, Australia) and mixed for 10 seconds, and applied to the cavity in a single step. The restorative material was polymerized for 20 seconds using an LED light device (VALO, Ultradent, Utah, USA). Equia Forte Coat was applied and polymerized for 20 seconds.

Group Type: EXPERIMENTAL

Caries Removal

Intervention Type: PROCEDURE

The cavity preparation and restoration were performed by a single operator. Infected dentin tissue was selectively removed. The differentiation between infected and affected dentin was determined by the clinician through the visual-tactile method.Isolation was achieved with cotton rolls and suction.

Filling

Intervention Type: PROCEDURE

Sectional matrix systems and interdental wedges were used to achieve an anatomical contour and contact. Then, the selected materials were placed in the cavity according to the manufacturers' recommendations.

Device: Resin-Modified Glass-ionomer Cement (Fuji II LC)

The material in capsule form was mixed in the mixer (Ultramat 2, SDI, Australia) for 10 seconds, and applied to the cavity in a single step. Polymerization was achieved using an LED light device (VALO, Ultradent, Utah, USA) for 20 seconds.

Group Type: EXPERIMENTAL

Caries Removal

Intervention Type: PROCEDURE

The cavity preparation and restoration were performed by a single operator. Infected dentin tissue was selectively removed. The differentiation between infected and affected dentin was determined by the clinician through the visual-tactile method.Isolation was achieved with cotton rolls and suction.

Filling

Intervention Type: PROCEDURE

Sectional matrix systems and interdental wedges were used to achieve an anatomical contour and contact. Then, the selected materials were placed in the cavity according to the manufacturers' recommendations.

Device: Bioactive Glass-Containing Alkasite (Cention N)

The material was mixed using a plastic spatula on a mixing pad or glass with a powder-to-liquid ratio of 1:1 until it reached a homogeneous consistency, which took approximately 45 -60 seconds. Then the material was applied to the cavity and allowed to set for its self-curing time of 4 and a half minutes.

Group Type: EXPERIMENTAL

Caries Removal

Intervention Type: PROCEDURE

The cavity preparation and restoration were performed by a single operator. Infected dentin tissue was selectively removed. The differentiation between infected and affected dentin was determined by the clinician through the visual-tactile method.Isolation was achieved with cotton rolls and suction.

Filling

Intervention Type: PROCEDURE

Sectional matrix systems and interdental wedges were used to achieve an anatomical contour and contact. Then, the selected materials were placed in the cavity according to the manufacturers' recommendations.

Device: Zinc-Reinforced High-Viscosity Glass-ionomer Cement (ChemFil Rock)

The material in capsule form was placed in the mixer (Ultramat 2, SDI, Australia) and mixed for 12 seconds, and applied to the cavity in a single step. In addition to the 90-second working time, an additional 4 and a half minutes were allowed for the material to cure.

Group Type: EXPERIMENTAL

Caries Removal

Intervention Type: PROCEDURE

The cavity preparation and restoration were performed by a single operator. Infected dentin tissue was selectively removed. The differentiation between infected and affected dentin was determined by the clinician through the visual-tactile method.Isolation was achieved with cotton rolls and suction.

Filling

Intervention Type: PROCEDURE

Sectional matrix systems and interdental wedges were used to achieve an anatomical contour and contact. Then, the selected materials were placed in the cavity according to the manufacturers' recommendations.

Interventions

Caries Removal

The cavity preparation and restoration were performed by a single operator. Infected dentin tissue was selectively removed. The differentiation between infected and affected dentin was determined by the clinician through the visual-tactile method.Isolation was achieved with cotton rolls and suction.

Intervention Type: PROCEDURE

Filling

Sectional matrix systems and interdental wedges were used to achieve an anatomical contour and contact. Then, the selected materials were placed in the cavity according to the manufacturers' recommendations.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

For participants:

• no known or suspected history of allergy to medications or restorative materials
• no habits of teeth grinding or clenching
• presence of at least one interproximal carious lesion

For teeth:

• carious lesion reaching at least 1/2 dentin
• in contact with adjacent teeth and in occlusion with antagonist teeth
• have no pathological mobility
• periodontally healthy
• no symptoms of pulpal pathology
• physiological root resorption should not exceed one-third of the root length if seen
• permanent tooth germ present below the tooth

Exclusion Criteria

• did not attend their follow-up appointments

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Zulfikar Zahit Ciftci

Head of Pediatric Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zulfikar Zahit Ciftci, Phd

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

Akdeniz University

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TDH- 2022-5832

Identifier Type: -

Identifier Source: org_study_id