Comparative Evaluation of Effectiveness of Hall Technique and Resin Modified Glass Ionomer Cement in Controlling Occlusoproximal Caries in Primary Molars in Children

May 13, 2020 updated by: Postgraduate Institute of Dental Sciences Rohtak

Comparative Evaluation of Effectiveness of Hall Technique and Resin Modified Glass Ionomer Cement in Controlling Occlusoproximal Caries in Dentin of Primary Molars in Children : A Randomized Clinical Study

•To investigate clinical and radiographic outcomes of Hall Technique and conventional restorative care using RMGIC in occulusoproximal carious lesions of primary molars in children.

Study Overview

Status

Status

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

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.

Detailed Description

Dental caries is one of the most common preventable diseases which is recognized as the primary cause of oral pain and tooth loss. WHO claimed that poor oral health may have a profound effect on general health as well as quality of life. Dental caries is not an infectious disease that needs to be "cured" by removing bacteria or, even less so, a particular bacterial species. Instead, dental caries can be managed behaviorally by controlling its causative factors-namely, the supply of fermentable carbohydrates and the presence and maturation of bacterial dental biofilms.

Resin modified Glass ionomer cement (RMGIC) has been used as a material for placement of dental restorations and is known to release fluoride which can help to remineralize carious lesion. RMGIC has excellent compressive and tensile strength compared to water based material, very less sensitive to moisture during initial setting time, excellent bonding with tooth, long working time with rapid set and early strength, have lower modulus of elasticity, twice flexible compared to water based glass ionomers. Chisini et al conducted a systematic review and showed 93.6% success rate of RMGIC, 91.2% for compomer, 79.3% for composite resin in primary teeth restoration.

The Hall Technique (HT) is a method for restoring children's carious primary molars uses a preformed stainless steel crown (SSC) cemented with no caries removal, tooth preparation, or local anaesthesia. Schwendicke F reported that HT showed high cost-effectiveness, dominating conventional restoration mainly because HT is clinically more successful and result in significantly fewer retreatments. The Hall Technique has been shown to be a durable (being likely to last the lifespan of the primary molar) and economical management option for primary molars with carious lesions, which in addition offers the benefit of full coronal coverage, reducing the risk of future carious lesion development.

The patients will be randomly allocated into two groups:

Group 1 - 45 Teeth will be treated using Hall Technique. Group 2 - 45 Teeth will be treated using resin modified glass ionomer cement(Vitremer).

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.
90

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

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001
        • Post Graduate Institute of dental sciences

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

4 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged between 4 to 8 years.
  • Occlusoproximal caries into dentin affecting one or more than one surface,
  • Crown is restorable.
  • Absence of clinical signs and symptoms
  • More than half root remaining.
  • No complicating medical history
  • Child able to co-operate.
  • Parent and child have consented.
  • Patient ready for radiographs.

Exclusion Criteria:

  • Signs or symptoms of irreversible pulpitis, or dental abscess/fistula.
  • Radiographic signs of pulpal involvement, or periradicular pathology.
  • Where there is no cooperation as there is a risk of crown aspiration or swallowing.
  • Patients at risk of infective endocarditis; immunocompromised children.
  • Parents/carers do not give written consent for treatment.

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: None (Open Label)

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.
Active Comparator: Hall Technique
In Hall Technique, SS Crown will be cemented on primary carious molar which satisfy the inclusion criterion without any carious removal, without any tooth preperation, without any local anaesthesia.
Procedure: Hall technique
SS Crown will be cemented on primary carious molar which satisfy the inclusion criterion without any carious removal, without any tooth preperation, without any local anaesthesia.
Active Comparator: RMGIC restoration
In RMGIC(Vitremer) filling, carious lesion will be completely removed from primary molars using air rotor and local anaesthesia according to need and filled with vitremer rmgic material.
Procedure: RMGIC restoration
Complete removal of caries and filling will be done with RMGIC material

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 success
Time Frame: Baseline to 12 months
Clinical success will be assessed by absence of clinical signs and symptoms
Baseline to 12 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
Radiographic success
Time Frame: Baseline to 12 months
Absence of periapical alterations (radiolucency at furcal or periapical region).
Baseline to 12 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.
Postgraduate Institute of Dental Sciences Rohtak

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.
November 1, 2019

Primary Completion (Anticipated)

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.
November 1, 2020

Study Completion (Anticipated)

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.
November 1, 2020

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).
April 17, 2020

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.
April 17, 2020

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.
April 21, 2020

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.
May 14, 2020

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.
May 13, 2020

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.
April 1, 2020

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.
  • Saurabh@Pedo#PGIDS

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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