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

Pulpitis - Irreversible Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308863
• Other study ID #: Chitosan vs MTA
• Status: Completed
• Phase: Phase 2
• Start date: November 15, 2018
• Est. completion date: December 20, 2020

Study information

• Verified date: May 2022
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 20, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View 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. — View 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. — View Citation

Li F, Liu X, Zhao S, Wu H, Xu HH. Porous chitosan bilayer membrane containing TGF-ß1 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mineralization Activity	Post-operative digital radio-graphic follow up will be done using the paralleling device to assess the rate of tooth mineralization	baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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