Evaluation of Pulp Symptoms After Minimal Caries Removal in Treatment of Deep Caries

June 27, 2021 updated by: Nouran Mamdouh Ahmed, Cairo University

Evaluation of Pulpal Symptoms Following Minimal Caries Removal Technique in Comparison to Complete Caries Removal in Molars With Deep Caries

The objective of this study is to assess and compare the possible post-operative pulpal symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of pulp exposure, child acceptance, chair time and radiographic success between two techniques for managing dental caries: minimal caries removal and complete caries removal 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

Minimal Caries Removal (MCR) technique was described in 2015 by Chompu-inwai et al., as a treatment option for primary molars with deep carious lesions or reversible pulpitis where only soft demineralized dentin around the lateral walls of the carious lesion is removed. The aim of this study is to assess the success of such a technique in managing primary molars with asymptomatic deep caries in terms of; post-operative pulpal symptoms(spontaneous pain, pain on percussion, fistula or sinus), incidence of pulp exposure, child acceptance, chair time and radiographic success.

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.
70

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

  • Egypt
    • El-manyal
      • Cairo, El-manyal, Egypt, 11553
        • Faculty of denntistry

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary molar with deep dentin caries involving occlusal &/or occluso-proximal surfaces.
  • Absence of clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Only presence of pain provoked with stimulation, such as complaints of food impaction when eating is allowed.
  • Absence of clinical swelling or pus exudates/fistula of soft or periodontal tissues.
  • Absence of abnormal tooth mobility.
  • Absence of pain on percussion.
  • Restorable tooth.

Radiographic inclusion criteria:

  • Extension of dental caries one-third or more of the entire dentin thickness.
  • No super- imposition of dental caries on the dental pulp.
  • No widened periodontal ligament (PDL) space.
  • No radiolucency in the peri-apical or furcation areas.
  • No pathologic internal or external root resorption.
  • No pulp canal calcification or obliteration.

Exclusion Criteria:

  1. Patients experience any signs or symptoms of pulpal or peri-apical pathology.
  2. Patients with systemic diseases requiring special dental consideration.
  3. Unmotivated, uncooperative patients.
  4. Patients unable to attend follow-up visits.

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: Double

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: Minimal caries removal
the patients in this group will be treated by minimal caries removal technique, where only caries at lateral walls of cavity is removed, stainless steel crown preparation is performed and then stainless steel crown is placed as final restoration.
Procedure: Minimal caries removal
the experimental group will be treated by minimal caries removal where only caries at lateral walls of cavity will be removed then stainless steel crown will be placed as final restoration.
Active Comparator: Complete caries removal
patients in this group will be treated by complete caries removal technique, where all caries will be removed, a base of resin modified glass ionomer is placed and then stainless steel crown is placed as final restoration.
Procedure: Complete caries removal
the control group will be treated by complete caries removal where all caries along lateral and pulpal walls of cavity will be removed, a base of resin modified glass ionomer will be placed then stainless steel crown will be placed as final restoration.

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
Post operative pain assessed by direct questioning as binary outcome
Time Frame: 9 months
Assessed by direct questioning pain history
9 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
incidence of pulp exposure
Time Frame: Within 30 minutes
The outcome will be measured during the treatment visit which is estimated to be 30 minutes
Within 30 minutes
radio-graphic success
Time Frame: 9 months
No external or internal root resorption, no periapical or furcation radiolucencies, no widening of periodontal membrane space
9 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

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.
December 15, 2018

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.
March 15, 2020

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 15, 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).
September 26, 2016

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.
September 27, 2016

First Posted (Estimate)

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.
September 29, 2016

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.
June 30, 2021

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.
June 27, 2021

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.
June 1, 2021

More Information

Terms related to this study

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-2016-09-206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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