Clinical & Radiographic Efficacy Using LLLT & CRYO on M.P.M Pulpotomy
NCT ID: NCT06711081
Last Updated: 2024-12-02
Study Results
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Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-11-30
2025-11-30
Brief Summary
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Detailed Description
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VPT depends on the theory that the pulp has the capacity of self-healing when it is free from infection. In addition, recent innovations of dental materials and techniques have been administrated to the field of endodontics have ensured higher success rate of VPT. Pulpotomy procedure has been introduced as an alternative to traditional root canal treatment in case of mature permanent teeth exhibiting symptoms of irreversible pulpitis when the radicular pulp is still vital.
There are many materials and techniques used for pulpotomy where the selection of the material used for this technique greatly influences its success rate. An ideal material for VPT must be biocompatible, antibacterial, providing biological and bacterial tight seal and promoting the regeneration of dentine-pulp complex. Calcium hydroxide (Ca(OH)2) and mineral trioxide aggregate (MTA) are considered the most commonly used materials for pulpotomy. However, Ca(OH)2 has many drawbacks as degradation over time, formation of tunnel defects beneath dentinal bridges and poor sealing ability, so it has lost its popularity as a first choice agent for pulpotomy. On the other hand, MTA has better sealing ability, biocompatibility and strength. However, it has some drawbacks like difficult handling, long setting time and discoloration of the tooth.
More recent pulpotomy materials have been introduced as putty bioceramic materials including: calcium silicate, monobasic calcium phosphate, zirconium oxide, tantalum oxide, and filler agents. They show better handling due to its premixed putty consistency in addition to its low level of tooth discoloration and rapid setting time compared to MTA.
In addition to the new materials, there are modifications of pulpotomy techniques which has been administrated to enhance its outcome as light amplification of estimated emission of radiation (LASER) and cryotherapy. The application of laser may enhance the outcomes of pulpotomy due to its ability to vaporize water in dental hard tissue so dentinal tubules will be opened and smear layer will be removed which in turn will increase the sealing ability of pulpotomy material.
One of the special forms of laser application is called low level laser therapy (LLLT) which can act as photoactivator on the pulp tissue cells by photostimulation without heat formation to enhance the cell differentiation and dentinogensis stimulation to promote tissue healing. In addition, it shows comparable effect to non-steroidal anti-inflammatory drugs (NASIDS), so it can be considered as an alternative to pain control through reduction of the exudative phase of inflammatory process, increasing synthesis of endorphins, decreasing bradykinin and altering pain threshold. On the other hand, the main disadvantages of laser include its uncontrolled depth of penetration through the tissue in addition to high cost of the laser device.
Moreover, Cryotherapy is another modified technique for pulpotomy. It is a procedure used to destroy tissue by freezing or re-thawing process through decreasing the temperature of the tissue. It has several physiological responses as decreasing of the local blood flow which can affect the homeostasis, temporary inhibition of the neural receptors in the pulp and decreasing of metabolic activity which in turn may affect the post-operative pain.
Cone beam computed tomography (CBCT) can be used for determination of periapical-periodontal status as it provides three dimensional demonstrations of the anatomic features plus accurate dimensional readings of the periapical tissue. The success of pulpotomy can be evaluated through the periapical-periodontal status radiographically which is confirmed clinically by absence of signs and symptoms.
Post-operative pain after pulpotomy is common. It is a noxious feeling after doing the procedure which may start immediately or later. Effective management of the post-operative pain is important in reducing the recovery time and improving patient outcomes
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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• Group I: Conventional complete Pulpotomy using MTA (control group).
MTA putty material will be placed using premixed capsule which will be triturated according to manufacturer's instructions. MTA will be placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed to the canal orifice using a condenser, then it will be covered by moistened cotton pellet for 2 minutes to achieve the initial setting, then the cotton pellet will be removed. A layer of resin modified glass ionomer cement will be placed and the tooth will be restored using light cured composite filling material .
No interventions assigned to this group
• Group II: LLLT following complete pulpotomy.
after achieving homeostasis, LLLT will be applied using diode laser of 810 nm wave length with energy of 2 J/cm2 under a continuous mode with power output of 100 mW for about 10 sec with laser tip size 600 μm and 2 mm away from the canal orifice, Then MTA will be placed and the tooth will be restored as in group I.
low level laser device cryotherapy
using new device direct on the pulp tissue
• Group III: Cryotherapy following complete pulpotomy.
after achievement of homeostasis, the cryotherapy will be applied using small piece of shaved sterile ice wrapped with sterile piece of gauze (0° Celsius) which will be placed over the pulpal tissue in the pulp chamber. After approximately 60 seconds, the molten ice will be removed, then MTA will be placed and the tooth will be restored as in group I.
low level laser device cryotherapy
using new device direct on the pulp tissue
Interventions
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low level laser device cryotherapy
using new device direct on the pulp tissue
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Teeth with deep caries or large restoration.
* Pre-operative radiograph showing normal periapical structure.
* Teeth with normal periodontal status .
Exclusion Criteria
* Teeth with periapical lesion.
* Sinus tract or swelling.
* Moderate or severe marginal periodontitis.
* Patient allergic to any material or medication used in this study.
* Teeth with moderate to severe mobility.
* Teeth with periodontal diseases.
* Teeth with anatomical variations.
15 Years
60 Years
ALL
Yes
Sponsors
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Tanta University
OTHER
Responsible Party
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mohamed motiea mohamed morsy
principle investigator
Principal Investigators
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abeer darrag, phd
Role: PRINCIPAL_INVESTIGATOR
Professor of Endodontics
tokka moukhatar
Role: STUDY_DIRECTOR
Lecturer of Endodontics
Locations
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Faculty of Dentistry
Tanta, , Egypt
Countries
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Central Contacts
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References
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Murray PE. Review of guidance for the selection of regenerative endodontics, apexogenesis, apexification, pulpotomy, and other endodontic treatments for immature permanent teeth. Int Endod J. 2023 Mar;56 Suppl 2:188-199. doi: 10.1111/iej.13809. Epub 2022 Aug 15.
Duncan HF, El-Karim I, Dummer PMH, Whitworth J, Nagendrababu V. Factors that influence the outcome of pulpotomy in permanent teeth. Int Endod J. 2023 Mar;56 Suppl 2:62-81. doi: 10.1111/iej.13866. Epub 2022 Nov 22.
Other Identifiers
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LLLT& CRYO pulpotomy on M.P.M
Identifier Type: -
Identifier Source: org_study_id