| CTRI Number |
CTRI/2024/07/070692 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Examination of the dental pulp tissue during a dental procedure on a milk tooth with inflammation of the pulp due to tooth decay |
|
Scientific Title of Study
|
Assessment of Intraoperative characteristics of dental pulp in carious
primary teeth with pulpitis |
| 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 Komal Yadav |
| Designation |
Junior Resident Academic |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Pediatric and Preventive Dentistry, Centre for Dental
Education and Research, AIIMS, New Delhi, Room 606, 6TH FLOOR
CDER AIIMS New Delhi
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910604304 |
| Fax |
|
| Email |
komalyadav2971999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Morankar Rahul Gangadharrao |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Pediatric and Preventive Dentistry, Centre for Dental
Education and Research, AIIMS, New Delhi, 6TH FLOOR
CDER AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910604304 |
| Fax |
|
| Email |
captainrahul88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Yadav |
| Designation |
Junior Resident Academic |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Pediatric and Preventive Dentistry, Centre for Dental
Education and Research, AIIMS, New Delhi, Room 606, 6TH FLOOR
CDER AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910604304 |
| Fax |
|
| Email |
komalyadav2971999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, CDER, AIIMS, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Dr Komal Yadav |
| Address |
Department of Pediatric and Preventive Dentistry, CDER,AIIMS New
Delhi 110029 |
| 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 Komal Yadav |
All India Institute of Medical Sciences |
Department of Pediatric and Preventive Dentistry, Centre for Dental
Education and Research, AIIMS, New Delhi, Room 606, 6TH FLOOR
CDER AIIMS New Delhi
New Delhi
New Delhi
DELHI |
09910604304
komalyadav2971999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
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 |
Access Opening of root canal under local anesthesia. |
Access opening of the pulp chamber and root canal will be done under local anesthesia of those teeth affected from pulpitis. Pulp status will be assessed by the colour and duration of bleed following which a diagnosis based on these characteristics will be made.
|
| Comparator Agent |
NIL |
NIL
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
(1) Age group 4 to 9 years.
(2) Primary maxillary/mandibular posterior tooth with deep occlusal and/or proximal caries
exhibiting the signs of pulpitis i.e. sensitivity and/or pain and/or pulp exposure which is
clinically evident [International Caries Detection and Assessment System Score 4, 5, and 6].
(3) Children with Frankl’s behavior rating of 3 and 4. |
|
| ExclusionCriteria |
| Details |
(1) Teeth with gingival abscess and/or extraoral swelling/sinus formation/pathological mobility
(2) Patients with systemic disorders and/or a history of long-term medications that can
influence the diagnosis.
(3) Frankl’s behavior rating of 1 and 2 [uncooperative children]
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will be assessing the colour of pulpal bleed and the duration within which pulpal bleeding stops as the intraoperative characteristics of pulp in the carious teeth affected by pulpitis |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="282"
Sample Size from India="282"
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)
|
01/08/2024 |
| 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="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 diagnosis based on history, clinical examination, and radiographic assessment has
limitations especially in the pediatric population as it relies on the patient’s response (pain,
sensitivity) and radiographs, which offer limited information about the pulp’s health itself. Pain
perception is considered subjective and varies between individuals and is less reliable in
children. Further, the percussion and sensibility tests depend on the patient’s interpretation,
leading to potential inaccuracies. To sum up, there is insufficient evidence to determine whether
the presence, nature, and duration of toothache offer accurate information about the extent to
which dental pulp is inflamed. Therefore, this cross-sectional study will assess the
intraoperative findings of dental pulp in carious primary teeth with pulpitis. These intraoperative findings will further help to serve as a standard to decide regarding the
type of treatment that needs to be rendered in carious teeth with pulpitis. Simultaneously, an
association can be drawn depending upon study results between the intraoperative dental
findings and their preoperative diagnosis.
|