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CTRI Number  CTRI/2024/10/075830 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 20/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical trial comparing different material and procedure in treatment of vital mature permanent molars with irreversible pulpitis and/or apical periodontitis. 
Scientific Title of Study   Comparative evaluation of coronal pulpotomy and partial radicular pulpotomy in vital mature permanent molars with irreversible pulpitis and/or apical periodontitis using chitosan and prf(platelet rich fibrin)-A Randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neelam Mittal 
Designation  Professor 
Affiliation  Faculty of Dental Sciences IMS BHU  
Address  Faculty of Dental Sciences Trauma center IMS BHU
3rd floor Department of conservative Dentistry and Endodontics.Faculty of Dental sciences IMS BHU
Varanasi
UTTAR PRADESH
221005
India 
Phone  9415203360  
Fax    
Email  dr.neelammittal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepti 
Designation  Academic Junior Resident 
Affiliation  Faculty of Dental Sciences IMS BHU 
Address  Faculty of Dental Sciences Trauma center IMS BHU Varanasi 221005
3rd floor Department of conservative Dentistry and Endodontics.Faculty of Dental sciences IMS BHU
Varanasi
UTTAR PRADESH
221005
India 
Phone  9871202627  
Fax    
Email  deeptirocks07@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepti 
Designation  Academic Junior Resident 
Affiliation  Faculty of Dental Sciences IMS BHU 
Address  Faculty of Dental Sciences Trauma center IMS BHU Varanasi 221005
3rd floor Department of conservative Dentistry and Endodontics.Faculty of Dental sciences IMS BHU
Varanasi
UTTAR PRADESH
221005
India 
Phone  9871202627  
Fax    
Email  deeptirocks07@gmail.com  
 
Source of Monetary or Material Support  
Faculty of Dental Sciences , IMS BHU Varanasi-221005 India 
 
Primary Sponsor  
Name  Faculty of Dental Sciences IMS BHU 
Address  Faculty of Dental Sciences IMS BHU varanasi -221005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepti  3rd floor Dept. of conservative Dentistry and endodontics Faculty of Dental Sciences IMS BHU   Faculty of Dental sciences IMS BHU Trauma center varanasi-221005
Varanasi
UTTAR PRADESH 
9871202627

deeptirocks07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Banaras Hindu University Institute of Medical Sciences Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  vital mature permanent molars with chronic irreversible pulpitis and/or apical periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Coronal pulpotomy versus partial Radicular pulpotomy using PRF(platelet Rich FIbrin)  Tooth will be anaesthetized using 2% lidocaine and then isolated with a rubber dam. Caries will be removed with round bur and low speed hand piece under sterile water spray. After complete carious excavation, pulp tissue will be removed to the level of canal orifice using sterile round bur in coronal pulpotomy group and removal of 3-4mm of radicular pulp from the level of orifice using a LN bur in partial radicular pulpotomy group. The bleeding will be controlled using a cotton pellet saturated with 3% sodium hypochlorite solution. Freshly prepared PRF with patients own blood sample (5ml i.v) centrifuged at 3000rpm for 10 mins is gently placed on pulp tissue of thickness 3-4mm in coronal pulpotomy group and thickness 3-4mm into root canals using root canal plugger till canals orifices in partial radicular pulpotomy group .Biodentine (SEPTODONT,USA) will be mixed and gently placed over the PRF in 2-3 mm thickness and allowed to set for 12 minutes. A layer of glass ionomer cement will be placed and after that a composite restoration will be placed. 
Comparator Agent  coronal pulpotomy versus partial radicular pulpotomy using chitosan  Tooth will be anaesthetized using 2% lidocaine and then isolated with a rubber dam. Caries will be removed with round bur and low speed hand piece under sterile water spray. After complete carious excavation, pulp tissue will be removed to the level of canal orifice using sterile round bur in coronal pulpotomy group and removal of 3-4mm of radicular pulp from the level of orifice using a LN bur in partial radicular pulpotomy group. The bleeding will be controlled using a cotton pellet saturated with 3% sodium hypochlorite solution. Freshly mixed chitosan powder 2gm with propylene glycol 2ml gently placed on pulp tissue of thickness 3-4mm in coronal pulpotomy group and thickness 3-4mm into root canals using root canal plugger till canals orifices in partial radicular pulpotomy group .Biodentine (SEPTODONT,USA) will be mixed and gently placed over the PRF in 2-3 mm thickness and allowed to set for 12 minutes. A layer of glass ionomer cement will be placed and after that a composite restoration will be placed. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1.Mature vital permanent molar
2.Possibly sensitive to percussion.
3.Strong and prolonged reaction to thermal testing, which can last for minutes.
4.Spontaneous dull pain that can be more or less suppressed by pain medication clinical diagnosis of irreversible pulpitis with/without periapical rarefaction.
5.ORSTAVIK’S PAI (periapical index) and CBCT PAI score ≤ 3.
6.No signs of pulpal necrosis including sinus tract or swelling.

 
 
ExclusionCriteria 
Details  1.Non restorable teeth.
2.Negative response to thermal testing, the presence of sinus tract or swelling.
3.Bleeding could not be controlled after pulpotomy in 5 minutes.
4.Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic
5.Medically compromised patient
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Decrease in visual analogue scale of pain.  1st,2nd,7th day 
 
Secondary Outcome  
Outcome  TimePoints 
No evidence of progression of periapical pathological finding in radiograph.  3 ,6 ,12 months 
Resolution of periapical pathology after treatment.  3 ,6 ,12 months 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   04/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  04/11/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Permanent teeth diagnosed with “irreversible pulpitis” have long been implied to have an irreversibly damaged dental pulp that is beyond repair and warranting root canal treatment. However, newer clinical approaches such as pulpotomy, a minimally invasive and biologically based procedure have re-emerged to manage teeth with pulpitis. Recent position statements from the American Association of Endodontists and the European Society of Endodontology (ESE) have concluded that ‘pre-treatment diagnosis of irreversible pulpitis is not necessarily an indication for pulpectomy’, heralding a new era for minimally invasive VPT in mature permanent teeth. In cases with irreversible pulpitis, the morphological changes indicating inflammation or necrosis were principally occurring in the coronal pulp whilst the radicular pulp was viable. This suggests that the radicular pulp could potentially be retained when a pulpotomy procedure is performed, thus preventing the need for a pulpectomy. This less invasive treatment approach called the Endolight concept was used by W.J. Wolters to propose a new classification for clinical pulp diagnosis.

According to this new classification, in cases of severe pulpitis (severe spontaneous pain and clear pain reaction to warmth and cold stimuli, often, sharp to dull throbbing pain, sensitive to touch and percussion) the treatment opted is full pulpotomy, If there is no pro-longed bleeding of pulp stumps in the orifices of the canals and if one or more of the pulp stumps keeps bleeding after rinsing with 2 mL 2% NaOCl, a superficial pulpotomy can be carried out, whereby more inflamed tissue is removed from the canal up to 3–4 mm from the radiographic apex (also known as radicular pulpotomy). Thus, indicating the need to disregard the closely held belief that a vital mature permanent tooth diagnosed with irreversible pulpitis will require root canal treatment for long-term preservation of the tooth rather than the less invasive vital pulp therapy (VPT).

Here in this study we would be using CHITOSAN and PRF as scaffold. 

Scaffolds are three-dimensional (3D) porous solid biomaterials which Provide a spatially correct position of cell location which helps in tissue regeneration.                                                                                  

 PLATELET RICH FIBRIN (PRF) is second-generation platelet concentrate named as Choukroun’s PRF after its inventor. PRF is biological and Ideal biomaterial for pulp-dentin complex regeneration. The procedure consists of drawing blood which is collected into test tubes without any anticoagulant and is centrifuged instantaneously. A tabletop centrifuge can be used for 10 min at 3000 rpm or for 12 min at 2700 rpm. It contains multitude of growth factors such as PDGF, TGF β1, and IGF. It prevents the early encroachment of undesired cells, thereby acts as a viable barrier between desired and undesired cells and accelerates wound closure with mucosal healing due to fibrin bandage and growth factor release.

CHITOSAN is synthetic biomaterial.  It is produced commercially by deacetylation of chitin, which is the structural element in the exoskeleton of crustaceans (such as crabs and shrimp) and cell walls of fungi. It is nontoxic, easily bioabsorbable, shows antibacterial activity, has gel forming ability, increases alkaline phosphatase activity, shows fibroblast and odontoblastic proliferation. It is a porous scaffold that can be molded into any shape and its hydrophilic property enhances cell attachment and proliferation.

 

Therefore, based on this data ,A study has been planned  comparing “ CORONAL PULPOTOMY AND PARTIAL RADICULAR PULPOTOMY IN VITAL MATURE PERMANENT MOLAR WITH IRREVERSIBLE PULPITIS AND/OR APICAL PERIODONTITIS USING CHITOSAN AND PRF”- A RANDOMISED CONTROLLED TRIAL.


 
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