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

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: Completed
• Conditions: Pulpitis - Irreversible
• Intervention / Treatment: Drug: Chitosan scaffold/ MTA pulp dressing material; Drug: MTA pulp dressing material

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: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21512
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	one week
Mineralization Activity	Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization	baseline
Mineralization Activity	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
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)	6 months
Peri-radicular/furcal pathosis	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	Cone beam computed tomography (CBCT) analysis will be performed to detect presence/absence of internal or external root resorption	12 months

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Collaborators: Alexandria University
• Investigators: 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

General Publications

• Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part IV: clinical effects on tissue healing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e56-60. doi: 10.1016/j.tripleo.2005.07.011.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Chitosan
• Other Study ID 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