CTRI Number |
CTRI/2019/06/019908 [Registered on: 27/06/2019] Trial Registered Prospectively |
Last Modified On: |
24/06/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Comparison of Three Different Root Canal Filling Materials for Root Canal Treatment in Children |
Scientific Title of Study
|
Clinical and Radiographic Outcomes of Three Root Canal Obturating Materials for Pulpectomy in Primary Mandibular Molars: A Double Blinded Randomized Controlled Trial. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Pragyna Priyadarshini |
Designation |
Post graduate student |
Affiliation |
Saveetha Dental College and Hospitals |
Address |
Department of Paediatric and Preventive Dentistry
Saveetha Dental College and Hospitals 162 Poonamallee high road Chennai
Chennai TAMIL NADU 600077 India |
Phone |
8457872002 |
Fax |
|
Email |
pragyna.mitan2012@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Deepa Gurunathan |
Designation |
Professor |
Affiliation |
Saveetha Dental College and Hospitals |
Address |
Department of Paediatric and Preventive Dentistry
Saveetha Dental College and Hospitals 162 Poonamallee high road Chennai
Chennai TAMIL NADU 600077 India |
Phone |
9994619386 |
Fax |
|
Email |
drgdeepa@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Deepa Gurunathan |
Designation |
Professor |
Affiliation |
Saveetha Dental College and Hospitals |
Address |
Department of Paediatric and Preventive Dentistry
Saveetha Dental College and Hospitals 162 Poonamallee high road Chennai
Chennai TAMIL NADU 600077 India |
Phone |
9994619386 |
Fax |
|
Email |
drgdeepa@yahoo.co.in |
|
Source of Monetary or Material Support
|
Self funded (Dr. Pragyna Priyadarshini
Postgraduate
Department of Paediatric and Preventive Dentistry
Saveetha Dental College and Hospitals |
|
Primary Sponsor
|
Name |
Pragyna Priyadarshini |
Address |
Department of Paediatric and Preventive Dentistry
Saveetha Dental College and Hospitals 162 Poonamallee High road Chennai 600077 |
Type of Sponsor |
Other [Self funded] |
|
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 |
Pragyna Priyadarshini |
Saveetha Dental College and Hospitals |
Department of Paediatric and Preventive Dentistry
5th Floor, Clinic number 28
Division of Dentistry
Chennai TAMIL NADU |
8457872002
pragyna.mitan2012@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Saveetha Dental College and Hospitals Scientific Review Board |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 2||Placement, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group 1 Endoflas-FS |
Endoflas-FS is a latest obturating material used for pulpectomy in children which consists basically of calcium hydroxide zinc oxide iodoform and liquid eugenol
Sample size 28 participants |
Intervention |
Group 2 Endoflas powder with Curcumin gel |
Endoflas powder is added to commercially available Curcumin gel and liquid eugenol is eliminated
Sample size 28 participants |
Comparator Agent |
Group 3 Pulpdent Root Canal Sealer Zinc oxide eugenol |
Pulpdent Root Canal Sealer consists of zinc oxide powder and liquid eugenol
Sample size 28 participants |
|
Inclusion Criteria
|
Age From |
4.00 Year(s) |
Age To |
9.00 Year(s) |
Gender |
Both |
Details |
Carious/deeply carious teeth with intra/extra-oral swelling/draining sinus tract
Abnormal mobility
Spontaneous pain with tender on percussion
Continuous bleeding on amputation of coronal pulp
Furcation/periapical radiolucency
Internal root resorption involving only cervical 1/3rd of root
External root resorption involving 1/3rd or less than 1/3rd of root length
|
|
ExclusionCriteria |
Details |
Children with systemic pathosis/special care needs
Untoward reaction to LA or to ingredients of test materials
Teeth not restorable/perforated pulpal floor
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
CLINICAL OUTCOMES :
Pain
Tenderness to percussion
Swelling/Abscess
Mobility
Draining fistula
RADIOGRAPHIC OUTCOMES :
Furcation/periapical radiolucency
Internal/External root resorption
Continuity of lamina dura
Deviation in path of eruption of succeedaneous tooth
Intra-radicular resorption
Resorption of extruded material
|
1 week
1 month
3 months
6 months
9 months
12 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Nil |
Nil |
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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 |
Date of First Enrollment (India)
|
08/07/2019 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
R. Pramila, M. S. Muthu, G. Deepa, J. M. Farzan, S. J. L. Rodrigues. Pulpectomies in primary mandibular molars: a comparison of outcomes using three root filling materials. Inter Endod J, 49, 413-421, 2016.
Mortazavi M, Mesbahi M (2004) Comparison of zinc oxideand eugenol, and Vitapex for root canal treatment ofnecrotic primary teeth. International Journal of PaediatricDentistry 14, 417–24.
Rewal N, Thakur A, Sachdev V, Mahajan N. Comparison ofendoflas and zinc oxide eugenol as root canal fillingmaterials in primary dentition. J Indian Soc Pedod Pre Dent2014;32(4):317e21.
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The primary objective of pulpal treatment is to preserve the integrity
and health of the oral tissues. Endodontics in primary teeth is even
more challenging because of the anatomic complexities, dynamic alteration
at the root apex and close proximity to the succedaneous tooth bud. In this
context root canal filling materials assume added importance, which must be
resorbable, anti-bacterial and biocompatible in nature. Zinc oxide eugenol
(ZOE) is the most widely used obturating material in primary teeth despite its
few drawbacks such as delayed resorption when extruded beyond the apex,
deflection in position of underlying successor tooth and its toxicity in
periradicular tissues. Thus to overcome such drawbacks, various obturating
materials and herbal derivatives have been introduced for pulpal treatment in
children.
Turmeric (Curcumin
Longa) is a medicinal herb and has been tested clinically for its antioxidant,
antiinflammatory and antimicrobial properties which can be effectively used as
an obturating material in primary teeth. The rationale behind the use of Curcumin
gel with Endoflas powder is to overcome the disadvantages of Endoflas-eugenol
mix.
Thus the present study is undertaken to evaluate the clinical and
radiographic outcomes of Endoflas, Endoflas powder with Curcumin gel and
Pulpdent root canal sealer (ZOE) as obturating materials in primary mandibular
molars. |