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

Primary Purpose

Pulpitis - Irreversible

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Chitosan scaffold/ MTA pulp dressing material
MTA pulp dressing material
Sponsored by
Nourhan M.Aly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chitosan scaffold/ MTA pulp dressing material

MTA pulp dressing material

Arm Description

Outcomes

Primary Outcome Measures

Pain Assessment
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.
Mineralization Activity
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Mineralization Activity
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Mineralization Activity
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Mineralization Activity
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Mineralization Activity
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Mineralization Activity
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Root Canal Obliteration
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Root Canal Obliteration
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Root Canal Obliteration
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Root Canal Obliteration
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Root Canal Obliteration
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Root Canal Obliteration
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Internal Root Resorption
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
Internal Root Resorption
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
Internal Root Resorption
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
Internal Root Resorption
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
Internal Root Resorption
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
Internal Root Resorption
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption

Secondary Outcome Measures

Changes in the dental pulp in treated teeth
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)
Peri-radicular/furcal pathosis
Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of any peri-radicular/furcal pathosis
Internal and external root resorption
Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of internal or external root resorption

Full Information

First Posted
March 9, 2020
Last Updated
May 18, 2022
Sponsor
Nourhan M.Aly
Collaborators
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04308863
Brief Title
Evaluation of Chitosan Scaffold and Mineral Trioxide Aggregate Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
Official Title
Evaluation of Chitosan Scaffold and Mineral Trioxide Aggregate Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nourhan M.Aly
Collaborators
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model 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).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chitosan scaffold/ MTA pulp dressing material
Arm Type
Experimental
Arm Title
MTA pulp dressing material
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Chitosan scaffold/ MTA pulp dressing material
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
MTA pulp dressing material
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Assessment
Description
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.
Time Frame
one week
Title
Mineralization Activity
Description
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Time Frame
baseline
Title
Mineralization Activity
Description
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Time Frame
1 month
Title
Mineralization Activity
Description
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Time Frame
3 months
Title
Mineralization Activity
Description
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Time Frame
6 months
Title
Mineralization Activity
Description
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Time Frame
9 months
Title
Mineralization Activity
Description
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization
Time Frame
12 months
Title
Root Canal Obliteration
Description
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Time Frame
baseline
Title
Root Canal Obliteration
Description
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Time Frame
1 month
Title
Root Canal Obliteration
Description
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Time Frame
3 months
Title
Root Canal Obliteration
Description
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Time Frame
6 months
Title
Root Canal Obliteration
Description
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Time Frame
9 months
Title
Root Canal Obliteration
Description
Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the presence/absence of canal obliteration
Time Frame
12 months
Title
Internal Root Resorption
Description
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
Time Frame
baseline
Title
Internal Root Resorption
Description
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
Time Frame
1 month
Title
Internal Root Resorption
Description
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
Time Frame
3 months
Title
Internal Root Resorption
Description
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
Time Frame
6 months
Title
Internal Root Resorption
Description
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
Time Frame
9 months
Title
Internal Root Resorption
Description
Post-operative digital radiographic follow up will be done using the paralleling device in order to assess the presence/absence of internal resorption
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in the dental pulp in treated teeth
Description
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)
Time Frame
6 months
Title
Peri-radicular/furcal pathosis
Description
Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of any peri-radicular/furcal pathosis
Time Frame
12 months
Title
Internal and external root resorption
Description
Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of internal or external root resorption
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Normal periapical structures. Small changes in bone structures. Change in bone structure with mineral loss. Periodontitis with well-defined radiolucent area. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha T Aboul Kheir, M.Sc
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rania M ElBackly, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Raef Sherif, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yasser Elkamary
Organizational Affiliation
European Egyptian Pharmaceutical Industries, Pharco Corporation, Alexandria, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nayera Mokhless, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21512
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
16504852
Citation
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Results Reference
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PubMed Identifier
20171353
Citation
Parirokh M, Torabinejad M. Mineral trioxide aggregate: a comprehensive literature review--Part III: Clinical applications, drawbacks, and mechanism of action. J Endod. 2010 Mar;36(3):400-13. doi: 10.1016/j.joen.2009.09.009.
Results Reference
background
PubMed Identifier
27994420
Citation
Kumar V, Juneja R, Duhan J, Sangwan P, Tewari S. Comparative evaluation of platelet-rich fibrin, mineral trioxide aggregate, and calcium hydroxide as pulpotomy agents in permanent molars with irreversible pulpitis: A randomized controlled trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):512-518. doi: 10.4103/0976-237X.194107.
Results Reference
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PubMed Identifier
24332410
Citation
Li F, Liu X, Zhao S, Wu H, Xu HH. Porous chitosan bilayer membrane containing TGF-beta1 loaded microspheres for pulp capping and reparative dentin formation in a dog model. Dent Mater. 2014 Feb;30(2):172-81. doi: 10.1016/j.dental.2013.11.005. Epub 2013 Dec 12.
Results Reference
background
PubMed Identifier
14580916
Citation
Ho MH, Kuo PY, Hsieh HJ, Hsien TY, Hou LT, Lai JY, Wang DM. Preparation of porous scaffolds by using freeze-extraction and freeze-gelation methods. Biomaterials. 2004 Jan;25(1):129-38. doi: 10.1016/s0142-9612(03)00483-6.
Results Reference
background

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

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