| CTRI Number |
CTRI/2023/04/051230 [Registered on: 03/04/2023] Trial Registered Prospectively |
| Last Modified On: |
31/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing the success of endodontic treatment in lower deciduous molars restored with zirconia crowns and bulk fill composite resins |
|
Scientific Title of Study
|
Comparison of success of endodontic treatment in primary mandibular molars restored with zirconia crown and bulk fill composite resins:a split mouth randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikitha Anna Zacharia |
| Designation |
post graduate student |
| Affiliation |
SRM Dental College Chennai |
| Address |
room no 3 PG block
SRM Dental College
Bharathi Salai , Chennai
Tamil Nadu
room no 3 PGblock
SRM Dental College
Bharathi Salai , Chennai
Tamil Nadu
Chennai
TAMIL NADU
600089
India |
| Phone |
7530065159 |
| Fax |
|
| Email |
nikitha5.08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shankar P |
| Designation |
Reader department of pediatric dentistry |
| Affiliation |
SRM Dental College Chennai |
| Address |
SRM Dental College
Bharathi Salai , Chennai
Tamil Nadu
SRM Dental College
Bharathi Salai , Chennai
Tamil Nadu
Chennai
TAMIL NADU
600089
India |
| Phone |
9884585808 |
| Fax |
|
| Email |
pedoshankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikitha Anna Zacharia |
| Designation |
post graduate student |
| Affiliation |
SRM Dental College Chennai |
| Address |
SRM Dental College
Bharathi Salai , Chennai
Tamil Nadu
SRM Dental College
Bharathi Salai , Chennai
Tamil Nadu
Chennai
TAMIL NADU
600089
India |
| Phone |
7530065159 |
| Fax |
|
| Email |
nikitha5.08@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Dental College
Bharathi Salai , Chennai
Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
nikitha anna zacharia |
| Address |
flat no S17 E Block
Jains AvantikaApartments
Manapakkam, Chennai
Tamil Nadu
600116 |
| Type of Sponsor |
Other [self ] |
|
|
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 |
| Nikitha Anna Zacharia |
SRM dental college ramampuram |
room no 3 , PG block department of pediatric and preventive dentistry
SRM Dental College,
Bharati Salai, Ramapuram
Chennai
Tamil Nadu
Chennai
TAMIL NADU |
7530065159
nikitha5.08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional review board (IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bulk fill composites |
group B bulk fill composites clinical and radiographic success at 1 month ,3 month ,6month duration |
| Comparator Agent |
zirconia crown |
group A : zirconia crown clinical ,radiographic evaluation assessed at 1 month, 3 month, 6 month duration |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1) co-operative children aged between 4 to 8 years.
2)presence of atleast one carious primary mandibular molar indicated for pulpectomy on either side of the mandibular arch.
3)primary molars with irreversible pulpitis or non vital pulp with restorable tooth structure and periodontal support confirmed by periapical radiographic examinations.
4) children whose parents gave consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1)children with speciaal health care needs
2) children with any underlying systemic conditions
3)children who are allergic to local anesthesia or any of the materials used in the study.
4)non restorable tooth
5)carious teeth exhibiting pre shedding mobility.
6)the presence of bone rare fraction involving more than a half of the root or root perforations.
7) tooth with underfilled or overfilled obturation. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
clinical and radiographic success of endodontic treatment at one month , three month and six months
at one month three month and six months |
clinical and radiographic success of endodontic treatment at one month ,three months and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
survival rate of restoration assessed .
parents and childrens acceptance |
survival rate of restorations at one month , three month and six month
parents and childrens acceptance immediately after treatment |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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 1 |
|
Date of First Enrollment (India)
|
10/04/2023 |
| 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="0"
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
|
In literature previous studies have compared the survival rate of stainless steel crowns and bulk fill composite restorations after pulpectomy but there are no studies comparing zirconia crowns and bulk fill composite restorations , this study is designed to evaluate and compare the survival of the restoration and success of endodontic treatment in primary mandibular molars restored with zirconia crown and bulk filled composite resins.so if bulk fill composite resin restorations show similar rate, it could be used as a cheaper and aesthetic post endodontic treatment alternative to zirconia crowns .This could be very beneficial for children for children in developing countries like India |