| CTRI Number |
CTRI/2024/08/072885 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing Zinc Oxide-Propolis, Ozonated Oil-Zinc
Oxide and Zinc Oxide Eugenol for filling the root canals of infected posterior milk teeth in children |
|
Scientific Title of Study
|
An in vivo comparative evaluation of Zinc Oxide-Propolis, Ozonated Oil-Zinc
Oxide and Zinc Oxide Eugenol as obturating materials in primary molars
|
| 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 Meenu Bhola |
| Designation |
Professor and Head of the Department |
| Affiliation |
Baba Farid University of Health Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, Dasmesh Institute Of Research and Dental Sciences, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9888023400 |
| Fax |
|
| Email |
meenubhola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aanchal Kataria |
| Designation |
postgraduate student |
| Affiliation |
Baba Farid University of Health Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, Dasmesh Institute Of Research and Dental Sciences, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
7009212406 |
| Fax |
|
| Email |
aanchalkhullar55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aanchal Kataria |
| Designation |
postgraduate student |
| Affiliation |
Baba Farid University of Health Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, Dasmesh Institute Of Research and Dental Sciences, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
7009212406 |
| Fax |
|
| Email |
aanchalkhullar55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dasmesh Institute Of Research and Dental Sciences, Faridkot, 151203 |
|
|
Primary Sponsor
|
| Name |
Dr Aanchal Kataria |
| Address |
Department of Pediatric and Preventive Dentistry, Dasmesh Institute Of Research and Dental Sciences, Faridkot,151203 |
| 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 |
| Dr Meenu Bhola |
Dasmesh Institute Of Research and Dental Sciences |
Department of Pediatric and Preventive Dentistry
Faridkot
PUNJAB |
9888023400
meenubhola@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ozonated Oil Zinc Oxide |
available in powder liquid form. after completing the biomechanical preparation, the powder and liquid is mixed into adequate consistency and pushed into the root canals of primary molars wih the help of spreader. |
| Comparator Agent |
Zinc Oxide Eugenol |
available in powder liquid form. after completing the biomechanical preparation, the powder and liquid is mixed into adequate consistency and pushed into the root canals of primary molars wih the help of spreader. |
| Intervention |
Zinc Oxide Propolis |
available in powder liquid form. after completing the biomechanical preparation, the powder and liquid is mixed into adequate consistency and pushed into the root canals of primary molars wih the help of spreader. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.The tooth should be restorable
2.Two-third of the root should be present
3.No radiographic evidence of internal or external pathological root resorption
4.No radiographic evidence of pulp floor perforations
5.No clinical or radiographic evidence of dentigerous cyst or follicular cyst or any pathology requiring enucleation
6.Tooth exhibiting all signs of irreversible pulpitis or necrotic pulp
7.When a planned tooth for pulpotomy shows excessive hemorrhage at the time of treatment
8.Co-operative and motivated patient.
9.Parents who are willing for the treatment, and have signed the informed consent form.
|
|
| ExclusionCriteria |
| Details |
1.Teeth with radiographic evidence of external or internal pathological root resorption
2.Periradicular pathosis involving the permanent tooth bud
3.Crown which is non-restorable
4.More than half of root resorbed
5.Presence of dentigerous cyst or follicular cyst
6.Loss of periodontal attachment with loss of bone support
|
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The evaluation of clinical and radiographic success rate of Zinc Oxide Propolis, Ozonated Oil Zinc Oxide and Zinc Oxide Eugenol as obturating materials in primary molar pulpectomy procedure over a follow up period of 3,6 and 9 months. Success will be determined using the Coll and Sadrian criteria(1996). |
immediately after obturation, at 3,6 and 9 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the ease of application of Zinc Oxide Propolis, Ozonated Oil Zinc Oxide & Zinc Oxide Eugenol as obturating materials. Additionally the study will assess post operative discomfort & time taken for resorption of material as observed through follow up radiographs |
Immediately after obturation, at 3, 6 & 9 months post operatively. |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
26/08/2024 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aanchalkhullar55@gmail.com].
- For how long will this data be available start date provided 01-09-2024 and end date provided 01-11-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The
selected teeth will be randomly divided into three groups according to the
obturation material used:
Group
I:
Teeth to be obturated using Zinc Oxide-Propolis
Group
II:
Teeth to be obturated using a mixture of Ozonated oil-Zinc Oxide
Group
III:
Teeth to be obturated using Zinc Oxide Eugenol
Tooth
preparation
The selected primary tooth will be isolated under rubber
dam after the administration of local anesthesia. Access to pulp chamber will
be gained with a sterile round bur #41 using a high-speed handpiece.
Pulp extirpation will be done, followed by biomechanical preparation which will
be initiated with a number 15-K file. The file will be used in a pull-back
action and will be then sequentially increased up till the desired size. The
length of the instrumentation will be deliberately kept 1mm short of the
radiographic apex. Each level of instrumentation will be followed by irrigation
with 1ml of 1% sodium hypochlorite and 2ml of normal saline. The
canals will then be dried with sterile absorbent paper points before
obturation. The prepared teeth will then be randomly and equally divided into
three groups based on the obturating material used.
Group
1 (Zinc Oxide-Propolis): Zinc oxide powder and propolis liquid, is
mixed onto a glass slab into a medium consistency and a suitable carrier is
used to obturate the canals.
Group
2 (Ozonated oil-Zinc Oxide): Zinc oxide powder and
ozonated oil liquid, is mixed onto a glass slab into a medium consistency and a
suitable carrier is used to obturate the canals.
Group
3 (Zinc Oxide Eugenol): Zinc oxide powder and eugenol liquid, is
mixed onto a glass slab into a medium consistency and a suitable carrier is
used to obturate the canals.
Following
obturation, all the selected teeth will then be restored using glass ionomer
cement followed by stainless steel crowns. |