Evaluation of Chitosan Scaffold and Mineral Trioxide Aggregate Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
NCT ID: NCT04308863
Last Updated: 2022-05-19
Study Results
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Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2018-11-15
2020-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Chitosan scaffold/ MTA pulp dressing material
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 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
50 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Nourhan M.Aly
OTHER
Responsible Party
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Nourhan M.Aly
Instructor of Dental Public Health and Statistician
Principal Investigators
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Maha T Aboul Kheir, M.Sc
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry, Alexandria University, Egypt
Rania M ElBackly, PhD
Role: STUDY_DIRECTOR
Faculty of Dentistry, Alexandria University, Egypt
Raef Sherif, PhD
Role: STUDY_CHAIR
Faculty of Dentistry, Alexandria University, Egypt
Yasser Elkamary
Role: STUDY_CHAIR
European Egyptian Pharmaceutical Industries, Pharco Corporation, Alexandria, Egypt
Nayera Mokhless, PhD
Role: STUDY_CHAIR
Faculty of Dentistry, Alexandria University, Egypt
Locations
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Faculty of Dentistry, Alexandria University
Alexandria, , Egypt
Countries
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References
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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.
Other Identifiers
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Chitosan vs MTA
Identifier Type: -
Identifier Source: org_study_id
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