| CTRI Number |
CTRI/2024/12/077738 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Preventive
Screening
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of Extra-Oral Time and Storage Medium on the Success of Replanted Lost Teeth. |
|
Scientific Title of Study
|
Cbct based comparative evaluation of avulsed teeth replantation outcomes : influence of extra-oral time and storage medium |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harsh Sanjaykumar Baldawa |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College, SIMATS University |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College Chennai Tamil nadu 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
8485841420 |
| Fax |
|
| Email |
Baldawaharsh.hb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh R |
| Designation |
Assistant professor |
| Affiliation |
Saveetha Dental College, SIMATS University |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College Chennai Tamil nadu 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
9895725236 |
| Fax |
|
| Email |
rameshr.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh R |
| Designation |
Assistant professor |
| Affiliation |
Saveetha Dental College, SIMATS University |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College Chennai Tamil nadu 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
9895725236 |
| Fax |
|
| Email |
rameshr.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College, SIMATS University |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College, SIMATS University |
| Address |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College Chennai Tamil nadu 600077 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 |
| Harsh Sanjaykumar Baldawa |
Saveetha Dental College, SIMATS University |
Clinic 28, Department of Pediatric and Preventive Dentistry, Saveetha Dental College Chennai Tamil nadu 600077 India
Chennai
TAMIL NADU |
8485841420
Baldawaharsh.hb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
protocol D - extraoral dry time less than 6 hours with standardised replantation protocol.
|
| Intervention |
Study group |
Protocol A - extra oral dry timeless than 12 hours with storage media like milk or saline.
Protocol B - extra oral dry time more than 24 hours with storage media like milk or saline.
Protocol C - extraoral drytime less than 24 hours with storage media like HBSS. |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children attending clinic with avulsed teeth and requires emergency management.
2. Children parents willing to undergo followup CBCT imaging for periapical evaluation following trauma and follow up for 12 months.
3. Cases where root canal treatment required before doing replantation.
4. Parents willing for informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Children with systemic condition or medication that affect healing example diabetes or immunosuppressant drugs.
2. Parents not willing for CBCT imaging.
3. Childrens with extensive orofacial trauma.
4. Parents not following up with follow up.
5. Poor quality of CBCT image or artifact. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Closure of open apex
2. Root resorption evaluation.
3. Tooth mobiility.
4. Periapical healing.
5. Quality of life.
|
Baseline, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Extra oral dry time
2. Storage medium
3. Survival rate. |
Baseline, 6 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/12/2024 |
| 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="0"
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
|
This study evaluates the outcomes of replantation in cases of avulsed permanent teeth treated with extraoral root canal treatment (RCT), using cone-beam computed tomography (CBCT) for precise assessment. A cluster randomized trial design is employed, with dental trauma care centers as clusters. Centers are randomized to different standardized management protocols, such as variations in extraoral dry time, storage medium, and replantation techniques. The study includes patients aged 9-14 years with a history of traumatic avulsion and extraoral dry time. Only cases with proper replantation protocols and consent for post-operative CBCT imaging are included. Outcomes focus on periapical healing, root resorption, and periodontal health, with a minimum follow-up of 6-12 months. Clusters implement assigned protocols, ensuring uniformity within centers while allowing comparison across groups. Statistical analysis accounts for clustering effects, using hierarchical models to evaluate the impact of management strategies on clinical and radiographic outcomes. By integrating CBCT imaging with a cluster randomized approach, the study aims to enhance evidence-based protocols for avulsed tooth management, improving long-term treatment success and patient care |