| CTRI Number |
CTRI/2025/02/080207 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study related to One-Step Treatment to Close the Open Root Tip Using Different Materials |
|
Scientific Title of Study
|
Clinical And Radiographic Evaluation Of Single Step Apexification Using Different Apical Barriers– An In Vivo 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 |
Dr Sadhna Manglani |
| Designation |
MDS student |
| Affiliation |
Government dental college and Hospital Ahmedabad |
| Address |
Department of Conservative Dentistry and Endodontics, Room number 9 Government dental college and Hospital Civil hospital campus Asarwa Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9770248890 |
| Fax |
|
| Email |
dr.sadhnamanglani03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Asthana |
| Designation |
Head of Department and Professor |
| Affiliation |
Government dental college and Hospital Ahmedabad |
| Address |
Department of Conservative Dentistry and Endodontics Room number 9 Government dental college and Hospital Civil hospital campus Asarwa Ahmedabad
Ahmadabad
GUJARAT
380005
India |
| Phone |
9824440656 |
| Fax |
|
| Email |
geetasthana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadhna Manglani |
| Designation |
MDS Student |
| Affiliation |
Government dental college and Hospital Ahmedabad |
| Address |
Department of Conservative Dentistry and Endodontics Room number 9 Government dental college and Hospital Civil hospital campus Asarwa Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
09770248890 |
| Fax |
|
| Email |
dr.sadhnamanglani03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative dentistry and Endodontics, Governmental dental college and hospital Ahmedabad Gujarat 380016 |
|
|
Primary Sponsor
|
| Name |
Ahmedabad dental corporation |
| Address |
Ahmedabad dental corporation near shahibaug hospital Asarwa Ahmedabad Gujarat India 380016 |
| Type of Sponsor |
Other [Ahmedabad dental corporation] |
|
|
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 SADHNA MANGLANI |
Government dental college and Hospital Ahmedabad |
Department of Conservative dentistry and Endodontics, Room no. 9
Ahmadabad
GUJARAT |
09770248890
dr.sadhnamanglani03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt Dental College and Hospital |
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 |
| Intervention |
2 weeks after access opening and biomechanical preparation, Apexification will be done. |
Intracanal medicament will be placed for 2 weeks for disinfection of the canal before placing MTA plug for apexification. Follow up will be taken after 3 months and 6 months. Total intervention time of 6 months. |
| Comparator Agent |
Different Apical barriers will be used in the study |
Evaluation of efficacy of apical barriers in prevention of extrusion of MTA and periapical healing.
Group1- Platelet rich fibrin
Group2- Collagen sponge
Group3- control group |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Permanent immature necrotic teeth due to trauma or due to dental caries resulting in open apex or blunderbuss canals requiring Root canal treatment. These cases might be associated with or without periapical lesion and associated with or without intraoral sinus tract.
|
|
| ExclusionCriteria |
| Details |
Patients with significant medical comorbidity
Presence of any evidence of root fracture
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cases of apexification done using apical barriers will show lesser or no extrusion of MTA allowing proper condensation against a firm barrier. |
Baseline, 1 week follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. PRF being autologous should show faster healing by inducing growth factors which might lead to faster periapical healing in PRF group.
2. Collagen sponge by functioning as a scaffold and by enabling increased vascularization should show faster periapical healing. |
The outcome will be assessed after 3 months, 6 months and 12 months. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="1"
Months="0"
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
|
MTA has gained considerable attention for single step apexification. However it can extrude beyond the apex impinging on the periodontal tissue. So to prevent the extrusion an apical matrix barrier is required against which MTA can be compacted efficiently without extrusion. Few materials which can serve the purpose include Platelet rich fibrin (PRF), Absorbable collagen.
|