| CTRI Number |
CTRI/2024/09/073303 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the treatment outcome of two medications used as root canal filling materials in children with primary tooth infections. |
|
Scientific Title of Study
|
Evaluation of treatment outcome in terms of clinical and radiographic presentation of Chitra HAP-fil TM and Zinc oxide Eugenol as pulpectomy medicaments in primary mandibular molars- A Randomised controlled trial. |
| 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 Sruthi Priyadharshiny S |
| Designation |
Post-graduate resident |
| Affiliation |
Government Dental College, Kottayam |
| Address |
Department of Pediatric and Preventive Dentistry,
Government Dental College,
Gandhinagar P.O.,
Kottayam,
Kerala.
Kottayam
KERALA
686008
India |
| Phone |
7358330681 |
| Fax |
|
| Email |
chinnusruthi13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeeva PP |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College, Kottayam |
| Address |
Department of Pediatric and Preventive Dentistry,
Government Dental College,
Gandhinagar P.O.,
Kottayam,
Kerala.
Kottayam
KERALA
686008
India |
| Phone |
9447300050 |
| Fax |
|
| Email |
jeevareghu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeeva PP |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College, Kottayam |
| Address |
Department of Pediatric and Preventive Dentistry,
Government Dental College,
Gandhinagar P.O.,
Kottayam,
Kerala.
Kottayam
KERALA
686008
India |
| Phone |
9447300050 |
| Fax |
|
| Email |
jeevareghu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry,
Govt. Dental College,
Gandhinagar P.O.,
Kottayam,
Kerala,
Pin code- 686008. |
|
|
Primary Sponsor
|
| Name |
Dr Sruthi Priyadharshiny S |
| Address |
Department of Pediatric and Preventive Dentistry,
Government Dental College,
Gandhinagar P.O.,
Kottayam,
Kerala,
Pin code- 686008. |
| 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 Sruthi Priyadharshiny S |
Government Dental College, Kottayam |
Department of Pediatric and Preventive Dentistry,
Government Dental College,
Gandhinagar P.O.,
Kottayam,
Kerala,
Pin code- 686008
Kottayam
KERALA |
7358330681
chinnusruthi13@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the Institutional Ethics Committee (IEC)/ Institutional Review Board (IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chitra HAP-Fil TM |
Each tooth will be anesthetized and isolated with a rubber dam. Following the access opening using sterile round carbide burs, the working length (WL) will be determined radiographically using RVG. Step-back biomechanical preparation using kedo-files and endo-motor will be done. This will be alternating with 1% sodium hypochlorite and normal saline irrigation. Obturation will be done using Chitra HAP-Fil TM. |
| Comparator Agent |
Zinc Oxide Eugenol |
Each tooth will be anesthetized and isolated with a rubber dam. Following the access opening using sterile round carbide burs, the working length (WL)
will be determined
radiographically using RVG. Step-back biomechanical preparation using kedo-files and endo-motor will be done. This will be alternating with 1% sodium hypochlorite and normal saline irrigation. Obturation will be done using Zinc Oxide Eugenol. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Children with signs of irreversible pulpitis in primary mandibular molars. Teeth should have adequate bone support with at least 2/3rd of intact root length with neither gingival swelling nor sinus tract.
|
|
| ExclusionCriteria |
| Details |
Grossly decayed teeth which cannot be restored. Any pathologic signs of external or internal resorption of the roots. Children with underlying systemic diseases and with special health care needs and those who exhibit negative and definitely negative Frankl behavior rating.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Radiographic Success assessed by RVG (Absence of: Furcation radiolucency, Abnormal root resorption, Deviated eruption of succedaneous teeth, Excess filling material and its resorption) |
9 months post-intervention period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical success (Absence of Pain, Swelling, Fistulous opening, & Abnormal mobility) |
9 month post-intervention period |
| Quality of Obturation assessed with RVG using Coll & Sadrian criteria, 1996. |
Immediate post-intervention period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
13/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The primary teeth are implicated to be the best space maintainer and so it is of utmost responsibility of the pediatric dentists to take the necessary measures to protect the pulpally involved primary teeth. There are a lot of materials to fill the root canals but none of them have a biomimetic property. The material used in this study; Chitra HAP-FilTM is a hydroxyapatite-based nanoparticle gel having biomimetic property with similar crystallography as that of the hard tissues of the tooth. Each tooth will be anesthetized and isolated using rubber dam. Following the access opening using sterile round carbide burs, the working length (WL) will be determined radiographically using RVG. Step-back mechanical preparation using kedo-files and endomotor will be done. This will be alternating with 1% sodium hypochlorite and normal saline irrigation. Obturation will be done using the respective materials in both the groups. Group 1: Obturation using Chitra HAP-FilTM medicament. Group 2: Obturation using Zinc Oxide Eugenol medicament.Post-obturation restoration will be done with Glass ionomer cement followed by a stainless-steel crown placement. The clinical and radiographic outcome will be measured after 9 months for those patients reporting with an intact stainless-steel crown by an investigator blinded to the study. |