Contemporary Restorative Materials in Primary Molars

Akdeniz University

Status: Completed

Conditions: Dental Caries

Treatments: Procedure: Filling; Procedure: Caries Removal

Study type: Interventional

Funder types: Other

Identifiers

NCT06544486

TDH- 2022-5832

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 5 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 4 patient groups

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

Experimental group

Description:

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.

Treatment:

Procedure: Filling

Procedure: Caries Removal

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

Experimental group

Description:

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.

Treatment:

Procedure: Filling

Procedure: Caries Removal

Device: Bioactive Glass-Containing Alkasite (Cention N)

Experimental group

Description:

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.

Treatment:

Procedure: Filling

Procedure: Caries Removal

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

Experimental group

Description:

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.

Treatment:

Procedure: Filling

Procedure: Caries Removal