| CTRI Number |
CTRI/2024/12/078499 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Pulpotec to preserve Decayed Primary Teeth in Children instead of Extraction. |
|
Scientific Title of Study
|
Efficacy of Pulpotec in Preserving Hopeless Necrotic Primary Teeth: A Prospective Clinical and Radiographic Study |
| 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 Jayalakshmi Pandranki |
| Designation |
Professor |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
Department of Pedodontics
GITAM Dental College and Hospital
Rushikonda
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9912860194 |
| Fax |
|
| Email |
mds.deepthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayalakshmi Pandranki |
| Designation |
Professor |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
Department of Pedodontics
GITAM Dental College and Hospital
Rushikonda
ANDHRA PRADESH
530045
India |
| Phone |
9912860194 |
| Fax |
|
| Email |
mds.deepthi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayalakshmi Pandranki |
| Designation |
Professor |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
Department of Pedodontics
GITAM Dental College and Hospital
Rushikonda
ANDHRA PRADESH
530045
India |
| Phone |
9912860194 |
| Fax |
|
| Email |
mds.deepthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| GITAM Dental College and Hospital
Rushikonda
Visakhapatnam
Andhra Pradesh 530045
India |
|
|
Primary Sponsor
|
| Name |
GITAM Dental College and Hospital |
| Address |
Rushikonda
Visakhapatnam
Andhra Pradesh 530045
India |
| 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 |
| Dr Jayalakshmi Pandranki |
GITAM Dental College and Hospital |
Department of Pedodontics and Preventive Dentistry
GITAM Dental College and Hospital
Rushikonda
Visakhapatnam
ANDHRA PRADESH |
9912860194
mds.deepthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Review Board(IRRB), GITAM Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, (2) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, (3) ICD-10 Condition: K046||Periapical abscess with sinus, (4) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Non instrumental endodontic therapy with Pulpotec. |
Under isolation, the pulp chamber was accessed and the necrotic pulp removed under irrigation using a round bur with a low-speed handpiece. Removal of pulpal debris from the chamber using spoon excavator, and copious irrigation with 1% sodium hypochlorite were performed. The chamber and orifice was dried with cotton pellets. Powder and Liquid was manipulated according manufacturer’s instructions.The mix was placed only in the pulp chamber and pressed with a plugger to ensure uniform adaptation to the pulp chamber. The remaining cavity was filled with ZOE. The tooth was restored with a hermetic Type IX GIC filling. The entire of the procedure was performed in a single visit. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children
The pulp is judged as necrotic or partially necrotic.
Tooth with poor periodontal support (mobile)
presence of sinus tract or swelling.
Presence of internal or pathologic external root resorption, calcification or pulp canal obliteration.
Prominent radiolucency at the furcation or periapical regions.
Restorable tooth |
|
| ExclusionCriteria |
| Details |
Unrestorable teeth
Children with debilitating diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical examination: The tooth should be devoid of pain, swelling, tender on percussion, mobility or fistula |
Baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Radiographic outcome:
Reduction in periapical pathology
|
3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2025 |
| 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="0"
Months="7"
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
|
Maintaining primary teeth as natural
space maintainers until their natural exfoliation is essential for proper
dental development. For non-vital primary molars with poor prognosis, a new
treatment approach is needed to avoid extraction in order to reduce apprehension in young children.This preliminary study aims to
evaluate the initial clinical and radiographic success of Pulpotec for non instrumental endodontic therapy(NIET) for treating non-vital primary teeth indicated for extraction.The study includes non-vital primary
molars in children aged 4 to 8 years. The molars were treated using NIET with
PULPOTEC. The procedure will be completed in a single visit. Follow-up evaluations were conducted clinically
and radiographically at 3 months and 6 months. Data obtained will be statistically analysed. |