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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulpitis - Irreversible

Intervention / Treatment
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* Drug: Chitosan scaffold/ MTA pulp dressing material
* Drug: MTA pulp dressing material


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chitosan scaffold/ MTA pulp dressing material<br> | Drug: Chitosan scaffold/ MTA pulp dressing material<br>* 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.<br>|
| Active Comparator: MTA pulp dressing material<br> | Drug: MTA pulp dressing material<br>* 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.<br>|

What is the study measuring?
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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 |