CTRI Number |
CTRI/2011/06/001776 [Registered on: 02/06/2011] Trial Registered Prospectively |
Last Modified On: |
05/02/2012 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Root canal treatment in milk teeth using three root canal filling materials: A Double-blinded Randomized Controlled Trial. |
Scientific Title of Study
|
Pulpectomies in Primary Molars Using Three Root Canal Filling Materials: 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 |
DrRPramila |
Designation |
Dentist[postgraduate] |
Affiliation |
Saveetha Dental College |
Address |
Dr.R.Pramila
postgraduate[pedodontics]
Saveetha dental college
162 Poonamallee gigh road
Velappanchavadi
Chennai
Chennai TAMIL NADU 600077 India |
Phone |
9003597232 |
Fax |
|
Email |
dr.pramee@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrMSMuthu |
Designation |
Pediatric Dentist |
Affiliation |
Saveetha Dental College |
Address |
Professor and Head of the Department
Department of Pedodontics and Preventive Dentistry
Saveetha dental college
162 Poonamallee gigh road
Velappanchavadi
Chennai
Chennai TAMIL NADU 600077 India |
Phone |
9444045094 |
Fax |
|
Email |
muthumurugan@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrRPramila |
Designation |
|
Affiliation |
|
Address |
Department of pedodontics and preventive dentistry
Room no 301
3rd floor
Saveetha dental college
162 Poonamallee gigh road
Velappanchavadi
Chennai
Chennai TAMIL NADU 600077 India |
Phone |
9003597232 |
Fax |
|
Email |
dr.pramee@gmail.com |
|
Source of Monetary or Material Support
|
saveetha dental college
saveetha university
162 poonamallee high road
velappanchavadi
chennai 77 |
|
Primary Sponsor
|
Name |
Dr R Pramila |
Address |
Dr R Pramila
Postgraduate
Department of Pedodontics
Saveetha dental college
Saveetha University
162 Poonamallee high road
Velappanchavadi
Chennai 77 |
Type of Sponsor |
Other [postgraduate student] |
|
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 R Pramila |
saveetha dental college |
Department of Pedodontics and Preventive Dentistry
Room no 301
3rd floor
Saveetha dental college
162 poonamallee high road
Velappanchavadi
chennai 77 Chennai TAMIL NADU |
9003597232
dr.pramee@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Saveetha Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
1. Non vital teeth
2. Teeth with deep carious lesion and exposures of pulp
3. Patients with the history of spontaneous pain
4. Teeth showing adequate bone support and root length
, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Pulpdent Root Canal Sealer Group |
A Zinc oxide eugenol preparation. A single visit pulpectomy procedure. Duration: 1 hour. |
Intervention |
RC Fill Group |
A combination of Zinc Oeide Eugenol and Iodoform. A single visit pulpectomy procedure. Duration of treatment: 1 hour. |
Comparator Agent |
Vitapex Group |
A combination of calcium hydroxide and iodoform. A single visit pulpetomy procedure. Duration: 1 hour. It is compared with RC Fill and Pulpdent Root Canal Sealer groups. |
|
Inclusion Criteria
|
Age From |
4.00 Year(s) |
Age To |
9.00 Year(s) |
Gender |
Both |
Details |
1. Non vital teeth
2. Teeth with mild or moderate mobility [grade I and II]
3. Teeth with deep carious lesion and exposures of pulp
4. Patients with the history of spontaneous pain
5. Teeth showing adequate bone support and root length
6. Teeth with no radiographically discernable internal or pathological external resorption
7. Teeth with inter-radicular and peri-radicular radiolucencies.
|
|
ExclusionCriteria |
Details |
Children with any medical history are excluded from the study. |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
clinical evaluation: Pain, Redness, Swelling/Abscess, Draining fistula and Mobility.
Radiographic evaluation: Furcation radiolucency, Periapical radiolucency, Internal/External root resorption, Deviated eruption of succedaneous teeth, Excessive filling material and its resorption.
|
Clinical and Radiographic evaluation of three root filling materials for a period of 3,6 and 12 months.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
No Secondary Outcome measures applicable for this study. |
Not applicable |
|
Target Sample Size
|
Total Sample Size="111" Sample Size from India="111"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
10/06/2011 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Pulpectomy is indicated in teeth that show evidence of chronic inflammation or necrosis in the radicular pulp, with or without periapical or furcation pathology. However, endodontic treatment of primary teeth is more challenging than that of their permanent counterparts; this is because of their anatomical complexities of their root canal systems and their proximity to the developing permanent tooth, coupled with the difficulty in behavior management in children. Presently, the most commonly used materials are: Zinc-Oxide Eugenol, Iodoform based pastes, and calcium hydroxide. In 1967, it was shown that ZOE set in a dense mass which resisted resorption and was very irritating to the periapical tissues in rats. In 1979, it was speculated that the resorption rate of ZOE and the root differed, resulting in small areas of ZOE paste possibly being retained and because of its hardness it might deflect the path of eruption of the succedaneous tooth. It also has limited antibacterial action, and cause necrosis of bone and cementum. Dominguez et al, reported that combining Iodoform and Calcium Hydroxide, it gave a success rate of 100%. But the main disadvantage was intra-radicular resorption of the material. A mixture of Calcium Hydroxide, ZOE, and Iodoform [ENDOFLAS] gave a success rate of 83% with good healing, having the resorption limited to the excess extruded extraradicularly, without washing intra-radicularly and resorptive capabilities and was said to be a good alternative to the traditionally used materials. There have been only limited human studies on this subject. The present study aims to evaluate the clinical and radiographic efficiency of three root filling materials – ZOE with Iodoform [RC Fill], Calcium hydroxide with Iodoform [VITAPEX], ZOE and Calcium hydroxide with Iodoform [ENDOFLAS], for a period of 3,6 and 12 months.
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