Indirect Pulp Treatment in Primary Molars (RCT)

August 28, 2019 updated by: Mohamed Farouk Rashed, Cairo University

Evaluation of Resin Modified Glass Ionomer Liner (Vitrebond™) Versus Calcium Hydroxide as Indirect Pulp Treatment Material Used in Deep Carious Lesions in Primary Molars: A Randomized Clinical Trial

This study was conducted to evaluate the clinical and the radiographic success of Dycal and Vitrebond as indirect pulp treatment materials in primary molars.

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.

Detailed Description

Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and radiographically as indirect pulp treatment materials in deep caries in primary molars.

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.
88

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.
  • Phase 4

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

  • Egypt
      • Cairo, Egypt, 11553
        • Faculty of Oral and Dental Medicine

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:

In compliance with AAPD, 2017 guidelines for pulp therapy "IPT is indicated in a primary tooth with no pulpitis or with reversible pulpitis when the deepest carious dentin is not removed to avoid a pulp exposure. The pulp is judged by clinical and radiographic criteria to be vital and able to heal from the carious insult"

In addition to:

I-Subjects:

  1. Medically free children, their parent(s) accepts to sign the informed consent.
  2. Age range from 4-8 years.

II-Molars:

  1. Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars).
  2. Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
  3. Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).

Exclusion criteria:

I-Subjects:

  1. Uncooperative children.
  2. Parents unable to attend follow up visits (even after explaining the importance of recall visits).

II-Molars:

  1. History of spontaneous pain (to exclude reversible pulpitis).
  2. Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
  3. Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).

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: Triple

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: IPT using Dycal (TM )
Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal
Drug: Indirect pulp treatment using Dycal (TM)
Partial caries removal and protection of the dental pulp with biocompatible material
Other Names:
  • Indirect pulp capping
Drug: Indirect pulp treatment using Vitrebond (TM )
Partial caries removal and protection of the dental pulp with biocompatible material
Other Names:
  • Indirect pulp capping
Experimental: IPT using Vitrebond (TM )
Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal
Drug: Indirect pulp treatment using Dycal (TM)
Partial caries removal and protection of the dental pulp with biocompatible material
Other Names:
  • Indirect pulp capping
Drug: Indirect pulp treatment using Vitrebond (TM )
Partial caries removal and protection of the dental pulp with biocompatible material
Other Names:
  • Indirect pulp capping

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
Number of cases reporting postoperative pain
Time Frame: 12 months
Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure
12 months
Number of cases reporting swelling
Time Frame: 12 months
Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure
12 months
Number of cases reporting sinus
Time Frame: 12 months
Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure
12 months
Number of cases reporting fistula
Time Frame: 12 months
Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure
12 months
Number of cases reporting tooth mobility
Time Frame: 12 months
Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure
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
Number of cases reporting external root resorption
Time Frame: 12 months
Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
12 months
Number of cases reporting internal root resorption
Time Frame: 12 months
Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
12 months
Number of cases reporting furcation involvement
Time Frame: 12 months
Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
12 months
Number of cases reporting widening of periodontal membrane space
Time Frame: 12 months
Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
12 months
Number of cases reporting periapical radiolucency
Time Frame: 12 months
Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
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.
Cairo 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: Shereen E Taha, Professor, Cairo 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.
August 1, 2016

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.
August 1, 2017

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 1, 2018

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).
August 18, 2018

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.
December 7, 2018

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.
December 10, 2018

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 30, 2019

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 28, 2019

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, 2019

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.
  • CEBD-CU-2014-11-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

final results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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