Evaluation of Chitosan Scaffold and Mineral Trioxide Aggregate Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis

May 18, 2022 updated by: Nourhan M.Aly
The aim of this study is to evaluate the clinical and radiographic outcomes of Chitosan scaffold and Mineral trioxide aggregate (MTA) when used as pulpotomy agents in mature permanent teeth with irreversible pulpitis.

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

Thirty permanent mandibular molars of patients with signs and symptoms of irreversible pulpitis will be selected. They will be randomly allocated into two groups, Group 1(Chitosan scaffold/ MTA pulp dressing materials), Group 2 (MTA pulp dressing material). A single visit full pulpotomy procedure will be carried out. Chitosan scaffold and / or MTA will be used as the pulp dressing materials. The teeth will be then restored with base of Glass ionomer cement followed by composite restoration.

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.
30

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 2

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
      • Alexandria, Egypt, 21512
        • Faculty of dentistry, Alexandria 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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants free from any systemic disease.
  • Deep caries in a permanent lower molar with mature roots.
  • Probing pocket depth and mobility within normal limits.
  • No signs of pulpal necrosis including sinus tract or swelling.
  • Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.
  • The tooth is restorable.

  • Clinical diagnosis of symptomatic irreversible pulpitis based on subjective and objective examinations:

    • Subjective examination: Patients complaining of intermittent or spontaneous pain or pain exacerbated by dramatic temperature changes especially to cold stimuli and lasting for a few seconds to several hours.

    • Objective examination:

      • Clinical examination: Teeth that will experience immediate, excruciatingly painful sensation as soon as the cold stimulus is placed on and which may last for a while even after the removal of the stimulus.
      • Radiographic examination: Preoperative radiographs will be taken using a paralleling device.

      • The periapical index developed by Orstavik et al. (1986)(35) will be used to score cases with periapical rarefaction during diagnosis and follow-up periods. It consists of five categories:

        1. Normal periapical structures.
        2. Small changes in bone structures.
        3. Change in bone structure with mineral loss.
        4. Periodontitis with well-defined radiolucent area.
        5. Severe periodontitis with exacerbating features. Score 1 and 2 are considered healthy, score 3-5 are considered diseased
      • The teeth that will be included should have score 1 or 2.

Exclusion Criteria:

  • Negative response to cold testing.
  • No pulp exposure after caries excavation.
  • Bleeding could not be controlled in 10 minutes after 2.5% NaOCl
  • Absence of bleeding from any of the canals.
  • Teeth with radiographic signs of internal resorption.
  • Pulpal calcifications.
  • Participants with stainless-steel wires and brackets.

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: Chitosan scaffold/ MTA pulp dressing material
Drug: Chitosan scaffold/ MTA pulp dressing material
Chitosan 3-D porous scaffold will be prepared. The chitosan scaffolds will be examined with the Scanning electron microscopy (SEM) to analyze the surface of the chitosan scaffolds. The scaffolds will be sterilized by Ethylene oxide and stored until further use. A piece of 2-mm thick chitosan scaffold will be gently placed onto the pulp chamber floor and covering the canal orifices, and then a 2-3 mm thick layer of fast setting EndoCem Zr MTA will be applied onto the chitosan scaffold and will be gently condensed with moistened cotton pellet to attain adequate thickness which will be confirmed radiographically. MTA will be allowed to set for 4-5 mins.
Active Comparator: MTA pulp dressing material
Drug: MTA pulp dressing material
MTA will be gently placed over the fresh pulp wound using an MTA carrier to a thickness of 2-3 mm. It will be condensed lightly with moistened cotton pellet to attain adequate thickness and confirmed radiographically. MTA will be allowed to set for 4-5 mins.

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
Pain Assessment
Time Frame: one week
Postoperative pain will be recorded on Numerical Rating Pain Scale (NRS) that will be given to the patient to record his pain intensity in the range between 0-10, until the seventh day after treatment. Pain on the NRS will be further categorized as: No pain (0), Mild (1-3), Moderate (4-6), and Severe (7-10) pain.
one week
Mineralization Activity
Time Frame: baseline
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
baseline
Mineralization Activity
Time Frame: 1 month
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
1 month
Mineralization Activity
Time Frame: 3 months
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
3 months
Mineralization Activity
Time Frame: 6 months
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
6 months
Mineralization Activity
Time Frame: 9 months
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
9 months
Mineralization Activity
Time Frame: 12 months
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
12 months
Root Canal Obliteration
Time Frame: baseline
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
baseline
Root Canal Obliteration
Time Frame: 1 month
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
1 month
Root Canal Obliteration
Time Frame: 3 months
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
3 months
Root Canal Obliteration
Time Frame: 6 months
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
6 months
Root Canal Obliteration
Time Frame: 9 months
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
9 months
Root Canal Obliteration
Time Frame: 12 months
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
12 months
Internal Root Resorption
Time Frame: baseline
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
baseline
Internal Root Resorption
Time Frame: 1 month
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
1 month
Internal Root Resorption
Time Frame: 3 months
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
3 months
Internal Root Resorption
Time Frame: 6 months
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
6 months
Internal Root Resorption
Time Frame: 9 months
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
9 months
Internal Root Resorption
Time Frame: 12 months
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
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
Changes in the dental pulp in treated teeth
Time Frame: 6 months
This will be performed in comparison to a non-affected tooth with clinical vitality and without any additional past treatment. All observers will analyze the images using the following rating scale regarding to alterations of signal intensity of the dental pulp at nT1w, fsT1w, and fsT2w at distinct time intervals (1 = no signs of alterations of signal intensity of the dental pulp between affected and non-affected teeth, 2 = slightly alterations of signal intensity of the dental pulp between affected and nonaffected teeth, and 3 = obvious alterations of signal intensity of the dental pulp between affected and nonaffected teeth)
6 months
Peri-radicular/furcal pathosis
Time Frame: 12 months
Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of any peri-radicular/furcal pathosis
12 months
Internal and external root resorption
Time Frame: 12 months
Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of internal or external root resorption
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.
Nourhan M.Aly

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alexandria 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: Maha T Aboul Kheir, M.Sc, Faculty of Dentistry, Alexandria University, Egypt
  • Study Director: Rania M ElBackly, PhD, Faculty of Dentistry, Alexandria University, Egypt
  • Study Chair: Raef Sherif, PhD, Faculty of Dentistry, Alexandria University, Egypt
  • Study Chair: Yasser Elkamary, European Egyptian Pharmaceutical Industries, Pharco Corporation, Alexandria, Egypt
  • Study Chair: Nayera Mokhless, PhD, Faculty of Dentistry, Alexandria University, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 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.
October 30, 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.
December 20, 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).
March 9, 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.
March 12, 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.
March 16, 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 19, 2022

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 18, 2022

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.
May 1, 2022

More Information

Terms related to this study

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.
  • Chitosan vs MTA

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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