| CTRI Number |
CTRI/2024/01/062166 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Dental treatment protocol for dental procedures in people with hemophilia |
|
Scientific Title of Study
|
Development of dental treatment regimen for various dental procedures for people with hemophilia: A mixed method 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 |
Mathangi Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department of Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal
Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09620299924 |
| Fax |
|
| Email |
mathangi.kumar@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mathangi Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department of Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal
Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09620299924 |
| Fax |
|
| Email |
mathangi.kumar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mathangi Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Department of Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal
Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09620299924 |
| Fax |
|
| Email |
mathangi.kumar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Mathangi K |
| Address |
Department of Oral Medicine and Radiology, MCODS,Manipal |
| Type of Sponsor |
Other [] |
|
|
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 Mathangi K |
Manipal College of Dental Sciences, Manipal |
Room No: 1, Department of Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA |
09620299924
mathangi.kumar@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D67||Hereditary factor IX deficiency, (2) ICD-10 Condition: D66||Hereditary factor VIII deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
• People with Hemophilia requiring dental treatment procedures
• People with Hemophilia willing to undergo dental procedure and be a part of this study
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Standardization of prophylactic clotting factor concentrate prior to various dental treatment procedures for patients with hemophilia |
This study shall be carried out over a period of 3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• A dental treatment regimen for PwH in India.
• Standardization of prophylactic clotting factor concentrate prior to various dental treatment procedures for patients with hemophilia
• Dental specialists translated into Hemophilia-Dentist
|
This study shall be carried out over a period of 3 years |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
09/02/2024 |
| 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="3"
Months="6"
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 comprehensive hemophilia treatment team comprises of a haematologist/ paediatrician, a nurse, a dentist, a physiotherapist, psychosocial expert in order to ensure an overall well-being of people with Hemophilia. This team approach ensures a good physical and psychosocial health and significantly reduces the morbidity of the disease. A comprehensive treatment care approach for people with hemophilia that facilitates a close interaction between the haematologist and the dental professional shall improve the confidence of patients to seek routine dental care.(John et al., 2017) Clinical trials that address the recommended haemostatic cover for various dental treatment procedures and their outcomes in India are limited. Hence, this project aims to formulate a standardized dental treatment regimen for people with hemophilia in a Comprehensive Hemophilia Treatment Center. |