NCT06544486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.3 years

First QC Date

July 26, 2024

Last Update Submit

August 5, 2024

Conditions

Dental Caries

Keywords

Cention NResin-modified glass-ionomer cementHybrid glass-ionomer cementZinc reinforced glass-ionomer cementPrimary Molar Teeth

Outcome Measures

Primary Outcomes (1)

  • Clinical evaluation of the filling materials according to the modified USPHS criteria

    Restorations were evaluated for retention, marginal discoloration, marginal adaptation, color stability, secondary caries, and postoperative sensitivity according to the modified USPHS with scores assigned as follows: the best being Alpha and the worst being Charlie. Each restoration received a score of Alpha, Bravo, or Charlie at each time interval.

    Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.

Secondary Outcomes (1)

  • Preservation of pulpal vitality

    Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.

Study Arms (4)

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

EXPERIMENTAL

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.

Procedure: Caries RemovalProcedure: Filling

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

EXPERIMENTAL

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.

Procedure: Caries RemovalProcedure: Filling

Device: Bioactive Glass-Containing Alkasite (Cention N)

EXPERIMENTAL

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.

Procedure: Caries RemovalProcedure: Filling

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

EXPERIMENTAL

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.

Procedure: Caries RemovalProcedure: Filling

Interventions

Caries RemovalPROCEDURE

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.

Device: Bioactive Glass-Containing Alkasite (Cention N)Device: Hybrid Glass-ionomer Cement (Equia Forte HT)Device: Resin-Modified Glass-ionomer Cement (Fuji II LC)Device: Zinc-Reinforced High-Viscosity Glass-ionomer Cement (ChemFil Rock)
FillingPROCEDURE

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)Device: Hybrid Glass-ionomer Cement (Equia Forte HT)Device: Resin-Modified Glass-ionomer Cement (Fuji II LC)Device: Zinc-Reinforced High-Viscosity Glass-ionomer Cement (ChemFil Rock)

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • did not attend their follow-up appointments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Zulfikar Zahit Ciftci, Phd

    Akdeniz University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The materials were visually different from each other, which allowed the investigators to identify each material. As a result, masking could only be performed with the participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Dentistry

Study Record Dates

First Submitted

July 26, 2024

First Posted

August 9, 2024

Study Start

March 1, 2021

Primary Completion

June 21, 2022

Study Completion

July 19, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations

TU(1)