| CTRI Number |
CTRI/2022/04/042051 [Registered on: 21/04/2022] Trial Registered Prospectively |
| Last Modified On: |
13/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating efficacy of PRF and Chorion membrane in regeneration. |
|
Scientific Title of Study
|
Comparative evaluation of Platelet Rich Fibrin (PRF) and chorion membrane as a scaffold in apexogenesis using Cone beam computed tomography (CBCT)- A randomised controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shanmathy B |
| Designation |
PG student |
| Affiliation |
TamilNadu Government Dental College and Hospital |
| Address |
Dept of Conservative Dentistry and Endodontics, No 1 venkatanarayan street extn, ullagarm oil mill,Madipakkam, Chennai.
Chennai
TAMIL NADU
600091
India |
| Phone |
8680809114 |
| Fax |
|
| Email |
shanmathy2921@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Kavitha |
| Designation |
Professor and HOD |
| Affiliation |
TamilNadu Government Dental College and Hospital |
| Address |
Dept of Conservative Dentistry and Endodontics. Room 1-10. No 1, TNPSC road, opp to fort station. chennai- 600003
Chennai
TAMIL NADU
600003
India |
| Phone |
9841161131 |
| Fax |
|
| Email |
kavithaendo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shanmathy B |
| Designation |
PG student |
| Affiliation |
TamilNadu Government Dental College and Hospital |
| Address |
Dept of Conservative Dentistry and Endodontics, No 1 venkatanarayan street extn, ullagarm oil mill, madipakkam, Chennai.
Chennai
TAMIL NADU
600091
India |
| Phone |
8680809114 |
| Fax |
|
| Email |
shanmathy2921@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tamil Nadu Government Dental College and Hospital, Chennai. |
|
|
Primary Sponsor
|
| Name |
Shanmathy B |
| Address |
No 1, venkat narayan street (extn)ullagaram oil mill
chennai- 600091 |
| 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 |
| Shanmathy B |
Tamil Nadu Government Dental College and Hospital |
Dept of Conservative Dentistry and Endodontics. Room 1-10.Muthusami salai opp fort station, Esplande George town, chennai- 600003
Chennai
TAMIL NADU |
8680809114
shanmathy2921@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tamil Nadu Government Dental College and Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chorion Membrane |
Commercially available processed freeze dried irradiated chorion membrane (2x2cm) cut into small pieces moistened with saline. Placed into root canal with help of plugger and coronal seal with Biodentin. Root development compared for period of 18 month. |
| Intervention |
PRF ( Platelet Rich FIbrin) membrane |
10 ml of venous blood centrifuged in test tube at 3000 rpm for 10 minutes. Blood clot and plasma removed . Platelet rich fibrin taken with sterile tweezer, packed in canal and sealed with Biodentin and evaluated for period of 18 months. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients with no systemic disease, Periodontally healthy individuals, Patients willing for voluntary participation and have signed the
informed consent, Patents with good oral hygiene
Patients with necrotic immature teeth exhibiting radiographic evidence of
open apex without periapical pathology or periapical pathology (<_10mm). |
|
| ExclusionCriteria |
| Details |
Patients who are allergic to Ciprofloxacin , Metronidazole or Minocycline, Patient with known systemic diseases, Teeth not conducive for rubber dam isolation, Grossly decayed or fractured teeth, Teeth with periapical radiolucency >10mm, Teeth with internal or External root resorption, Periodontally compromised teeth,Patients with bleeding disorders,Platelet count < 1,50,000/mm3, Pregnant women in view of requirements for radiographs. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical ssessment of positive pulp response, abscence of mobility, pain , tenderness
to percussion and reduction of periodontal probing depth |
3,6,9,12,15,18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Radiographic assessment of increase in root length , dentin wall thickness and narrowing of
canal space, root development and apical end closure |
3,6,9,12,15,18 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
04/05/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, double blind, parallel arm design comparing the effect of Platelet Rich Fibrin (PRF) and Chorion membrane as a scaffold in apexogenesis using cone beam computed tomography (CBCT) carried out in Tamil Nadu Government Dental College and Hospital among 20 patients of age group 13 to 30 years of both gender with immature necrotic teeth exhibiting radiographic evidence of open apex. The primary outcome being clinical evaluation of positive pulp response, absence of mobility, pain, tenderness to percussion and reduction of periodontal probing depth. Secondary outcome being radiographic evidence of increase in root length, dentin wall thickness and narrowing of canal space, root development and apical end closure at end of 3,6,9,12,15,18 months.
|