Contemporary Restorative Materials in Primary Molars

August 5, 2024 updated by: Zulfikar Zahit Ciftci, Akdeniz University

Clinical Evaluation of Contemporary Ion Releasing Restorative Materials in Primary Molars Subjected to Selective Caries Removal: A Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Procedure: 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.
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.
Experimental: 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.
Procedure: 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.
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.
Experimental: 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.
Procedure: 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.
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.
Experimental: 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.
Procedure: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical evaluation of the filling materials according to the modified USPHS criteria
Time Frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preservation of pulpal vitality
Time Frame: Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.
The modified USPHS criteria do not include the measure of pulpal vitality when evaluating the success of restorations. However, maintaining pulpal vitality is also a criterion for the success of a restoration and is assessed not by a graded score but by the presence or absence of symptoms and findings. In this study, pulpal vitality was clinically evaluated based on the presence or absence of percussion sensitivity, palpation sensitivity, gingival redness, fistula or abscess. If percussion sensitivity, palpation sensitivity, or the formation of a fistula or abscess were present, the restoration was classified as unsuccessful regarding pulpal vitality. In cases of gingival redness or unclear clinical symptoms, a periapical radiograph was taken. If presence or absence of radiolucency in the periapical or furcal area was detected in the radiograph, the restoration was classified as unsuccessful regarding pulpal vitality.
Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zulfikar Zahit Ciftci, Phd, Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TDH- 2022-5832

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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