| 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
|
|
|
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
|
|
|
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 PRFâ€- A RANDOMISED
CONTROLLED TRIAL.
|