| CTRI Number |
CTRI/2021/06/033976 [Registered on: 03/06/2021] Trial Registered Prospectively |
| Last Modified On: |
02/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparative evaluation of three root canal obturating material for primary teeth namely- metapex, metapex with absorbable gelatin sponge and zinc oxide powder with 10% sodium fluoride. |
|
Scientific Title of Study
|
comparative evaluation of three root canal obturating materials for primary teeth namely- metapex, metapex with absorbable gelatin sponge and zinc oxide powder with 10% sodium fluoride: an in vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranu Rai |
| Designation |
PG Student |
| Affiliation |
SGT Medical Hospital And Research Center, SGT University, Gurugram, Haryana. |
| Address |
Room no. 6, Department of Pediatric and Preventive Dentistry,
Faculty of Dental Sciences, SGT University, Gurugram, Haryana,
India
Gurgaon
HARYANA
122505
India |
| Phone |
7838377312 |
| Fax |
|
| Email |
ranu.rai523@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Srivastava |
| Designation |
Professor |
| Affiliation |
SGT Medical Hospital And Research Center, SGT University, Gurugram, Haryana. |
| Address |
Room no. 6, Department of Pediatric and Preventive Dentistry,
Faculty of Dental Sciences, SGT University, Gurugram, Haryana,
India.
Gurgaon
HARYANA
122505
India |
| Phone |
8930093844 |
| Fax |
|
| Email |
drankitsri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ranu Rai |
| Designation |
PG Student |
| Affiliation |
SGT Medical Hospital And Research Center, SGT University, Gurugram, Haryana. |
| Address |
Room no. 6, Department of Pediatric and Preventive Dentistry,
Faculty of Dental Sciences, SGT University, Gurugram, Haryana,
India
Gurgaon
HARYANA
122505
India |
| Phone |
7838377312 |
| Fax |
|
| Email |
ranu.rai523@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT Dental College, Hospital and Research Center, SGT University, Budhera, Gurugram. |
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
Faculty of Dental Sciences, SGT University, Gurugram-122505 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ranu Rai |
SGT Dental college |
Room no.6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University
Gurgaon
HARYANA |
7838377312
ranu.rai523@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI GURUGOBIND SINGH TRICENTENARY UNIVERSITY, GURUG RAM,HARYANA |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Deep Dental caries involving primary molars |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
use of 10% sodium fluoride with zinc oxide powder as obturating material in primary molars |
use of 10% sodium fluoride with zinc oxide powder as obturating material in primary molars with follow up of one year |
| Intervention |
use of absorbable gelatin sponge with metapex as obturating material in primary molars |
use of absorbable gelatin sponge with metapex as obturating material in primary molars with follow up of one year |
| Comparator Agent |
use of metapex as obturating material in primary molars |
use of metapex as obturating material in primary molars with follow up of one year |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age group 4-8 years.
2. Tooth indicted for pulpectomy.
|
|
| ExclusionCriteria |
| Details |
1. Children with any systemic disease
2. Medically compromised children
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative evaluation of three root canal obturating materials for primary teeth namely- Metapex, Metapex with absorbable gelatin sponge and zinc oxide powder with 10% sodium fluoride. |
Patients will be examined clinically at 3,6,9 and 12 month and radiographically at 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate clinical and radiographic success rate of metapex with absorbable gelatin sponge.
2. To evaluate clinical and radiographic success rate of zinc oxide powder with 10% sodium fluoride.
3. Quality of obturation of metapex with absorbable gelatin sponge and zinc oxide powder with 10% sodium fluoride.
4. To compare the resorption rate of metapex with absorbable gelatin sponge and zinc oxide powder with 10% sodium fluoride with physiological primary tooth root. |
Patients will be examined clinically at 3,6,9 and 12 month and radiographically at 6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2021 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Properties of an ideal root canal filling material should be: antibacterial, resorbs at the same rate as the root, not causing any harm to periapical tissues, fluid tight seal along the length of canal, resorb if extruded beyond apex, adhere to the canal wall, radiopaque in radiograph, do not cause any discoloration to the tooth. Another commercially available iodoform based materials are: walkhoffâ€s paste, kri paste, maisto paste and metapex.(11) Metapex is another successful root canal material. It is a known bactericidal that suppresses any residual bacteria in the canal or periapcal region. It doesn’t show toxic effects on permanent successor and is radiopaque. However, conventional metapex does not have adequate handling properties and have tendency to extrude beyond the apex due to its viscosity.(12) Zinc oxide eugenol is widely used primary tooth obturating material. However, Zinc oxide eugenol has certain disadvantages, that is slow resorption and irritation to periapical tissues.(13) 10% sodium fluoride was added to zinc oxide powder to overcome these disadvantages. The resorption rate of the material was seen to be same as physiological root resorption. Iodoform based material like metapex have tendency to extrude beyond apex due to low viscosity. Thus, there was need to add an agent to increase the viscosity of the metapex, which would decrease the extrusion of obturating material periapically to give desired consistency. Absorbable gelatin sponge (AGS) is an absorbable material and appropriate to fulfil our purpose. Metapex manipulated with minced particles of absorbable gelatin sponge maintained the viscosity of the paste and was suggested as novel approach for obturation in primary teeth.(12) As Zinc oxide eugenol is gold standard obturating material, but because of its few shortcomings, combination of Zinc oxide powder with fluoride is being introduced. Further to improve Metapex, Metapex manipulated with minced particles of absorbable gelatin sponge is also being introduced. We are carrying out a comparison among (i) Metapex (ii) metapex with absorbable gelatin sponge and (iii) zinc oxide powder with 10% sodium fluoride to access the quality of obturation in primary teeth. Thus, in the present study we will evaluate the efficacy of three obturating materials i.e., metapex, metapex with absorbable gelatin sponge and zinc oxide powder with 10% sodium fluoride. |