| CTRI Number |
CTRI/2025/06/088698 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The types of dental injuries and treatments needed for kids who went to Sgt Dental College and Hospital in Gurugram |
|
Scientific Title of Study
|
Pattern of Traumatic Dental Injuries and Treatment Needs in children attending SGT Dental College, Hospital and Research Institute, Chandu, Budhera, Gurugram. |
| 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 Nikita Yadav |
| Designation |
Post Graduate Student |
| Affiliation |
SGT University, Gurugram, Haryana |
| Address |
Room no. 202, Department of Pediatric and Preventive Dentistry, faculty of Dental Sciences Shree Guru Gobind Singh Tricentenary University, Gurgoan-Badli Road Chandu, Budhera, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9582201344 |
| Fax |
|
| Email |
yadavnikita625@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anil Gupta |
| Designation |
Professor and Head of Department |
| Affiliation |
SGT University, Gurugram, Haryana |
| Address |
Room number 202 Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences Shree Guru Gobind Singh Tricentenary University, Gurgoan-Badli Road Chandu, Budhera, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9899039805 |
| Fax |
|
| Email |
anil.gupta@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Yadav |
| Designation |
Post Graduate Student |
| Affiliation |
SGT University, Gurugram, Haryana |
| Address |
Room number 202 Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences Shree Guru Gobind Singh Tricentenary University, Gurgoan-Badli Road Chandu, Budhera, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9582201344 |
| Fax |
|
| Email |
yadavnikita625@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT University, Gurugram, Haryana 122505 |
|
|
Primary Sponsor
|
| Name |
SGT University, Gurugram,Haryana 122505 |
| Address |
Room number 202,Department of pediatric and preventive Dentistry,Faculty of Dental sciences, SGT University,Gurugram, Haryana 122505 |
| 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 Nikita Yadav |
SGT Dental Hospital , Gurugram, Haryana 122505 |
Room number 202 Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences Shree Guru Gobind Singh Tricentenary University, Gurgoan-Badli Road Chandu, Budhera, Gurugram, Haryana
Gurgaon
HARYANA |
09582201344
yadavnikita625@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICSS COMMITTEE- SGT Dental college, Hospital and Research Institute ( IEC- SGTDCHRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pattern of Traumatic Dental Injuries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trauma Assessment Form AAPD, Pattern of assessment of traumatic Dental Injuries |
Patients will be assessed and treatment needs for traumatic dental injuries reporting to the OPD in the duration of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Children between age group 0 to 14 years.
2. All the patients reporting to the department OPD with traumatic Dental injuries will be included in the study for duration of 6 months.
3. Children assessed on the basis of whether treatment was received, neglected o have come up to seek treatment. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To evaluate patterns of traumatic dental injuries in children for 6 months
2) To assess the treatment needs by the children who experienced traumatic dental injuries. |
1)To evaluate patterns of traumatic dental injuries in children for 6 months
2) To assess the treatment needs by the children who experienced traumatic dental injuries. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To educate & guide patients & their parents for the specific treatment to be carried out in patients who have not received the treatment for 6 months |
To educate & guide patients & their parents for the specific treatment to be carried out in patients who have not received the treatment for 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/07/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Traumatic dental injuries occur
frequently in children and young adults, comprising 5% of all injuries which
are critical from aesthetic purpose as well as financially burdening.
The prevalence of traumatic
dental injuries to anterior teeth among children has been found to vary greatly
across different age group.
Reported & treated promptly,
traumatized teeth can have better prognosis, protecting children from
complications including tooth loss & psychological deficit. So, the study is planned to
assess pattern of dental injuries & treatment needs
in developing years of children.
The data of the study being
conducted will be collected from parents/ guardians after taking their consent using a standardized record sheet questionnaire, history will be recorded followed by clinical and radiographic examination
wherever required will
be done to obtain information.
The following information
will be collected during the clinical examination: number of traumatized teeth
and type of tooth / teeth involved, type of dental trauma and vitality of the
traumatized tooth/ teeth
Treatment will be planned and
carried out in the department of pediatric and preventive dentistry based on
the findings of the clinical and radiographic examination and data will be analyzed
statistically. These children who will be
assessed for traumatic dental injuries will be divided into 3 groups-
Group A - 0 to 5 years Group B - 6 to 9 years Group C - 10 to 14 years These children will also be
assessed on the basis of whether the treatment was received, neglected or have
come up to seek treatment.
|