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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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 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.
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
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.
Time frame: 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
Time frame: baseline
Mineralization Activity
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
Mineralization Activity
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
Mineralization Activity
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
Mineralization Activity
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
Mineralization Activity
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
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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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
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)
Time frame: 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
Time frame: 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
Time frame: 12 months