| CTRI Number |
CTRI/2018/03/012737 [Registered on: 22/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
17/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
a clinical trial to study the effects of three different type of restorative materials like Biodentine, MTA and Calcium phosphate cement in patients with infection in newly erupted teeth with incomplete root formation.
|
|
Scientific Title of Study
|
A comparative evalution of MTA, biodentine and calcium phosphate cement in single visit apexification procedure for non-vital immature permanent teeth-a randomized 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 |
Anjal yadav |
| Designation |
junior resident |
| Affiliation |
King George Medical University |
| Address |
Department of Pediatric and Preventive Dentistry, King George Medical University, Faculty of Dental Sciences Lucknow. Lucknow UTTAR PRADESH
Department of Pediatric and Preventive Dentistry, King George Medical University, Faculty of Dental Sciences Lucknow. Lucknow UTTAR PRADESH
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8564021137 |
| Fax |
|
| Email |
anjali.gudiya010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar Chak |
| Designation |
Professor |
| Affiliation |
King George Medical University |
| Address |
Department of Pediatric and Preventive Dentistry, King George Medical University, Faculty of Dental Sciences Lucknow. Lucknow UTTAR PRADESH
Department of Pediatric and Preventive Dentistry, King George Medical University, Faculty of Dental Sciences Lucknow. Lucknow UTTAR PRADESH
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9453904150 |
| Fax |
|
| Email |
dr.chakrakeshkr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Khanna |
| Designation |
Associate professor |
| Affiliation |
King George Medical University |
| Address |
Department of Pediatric and Preventive Dentistry, King George Medical University, Faculty of Dental Sciences Lucknow. Lucknow UTTAR PRADESH
Department of Pediatric and Preventive Dentistry, King George Medical University, Faculty of Dental Sciences Lucknow. Lucknow UTTAR PRADESH
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9936038511 |
| Fax |
|
| Email |
richa.bahal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences King George Medical University, Lucknow 226003 |
|
|
Primary Sponsor
|
| Name |
DrAnjali Yadav |
| Address |
Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, KGMU, Lucknow
|
| Type of Sponsor |
Government medical college |
|
|
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 Anjali Yadav |
King George Medical University, Faculty of Dental Sciences |
Department of Pediatric and Preventive Dentistry, Lucknow UTTAR PRADESH Lucknow UTTAR PRADESH
Lucknow
UTTAR PRADESH |
8564021137
anjali.gudiya010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
immature permanent teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biodentine |
Biodentine in putty like consistency carried to the root end of the immature permanent teeth.
|
| Intervention |
calcium phosphate |
calcium phosphate cement mixture is carried to root end of the immature permanent tooth. |
| Comparator Agent |
MTA (Mineral Trioxide Aggregate)
|
MTA paste in putty like consistency will be delivered to root end of immature permanent teeth.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.patients presenting with a non vital immature permanent teeth as a consequence of trauma or dental caries.
2. Non vital permanent teeth with radiographic evidence of immature root end developement.
3.Restorable non vital immature permanent teeth. |
|
| ExclusionCriteria |
| Details |
1.Immature non vital permanent teeth presenting with signs/symptoms of internal/internal resorption, moderate to severe mobility, peridontol bone loss, lack of restorability.
2.Immature non-vital permanent teeth with associated developmental abnormalities.
3.Patients with history of systemically debilitating diseases like uncontrolled diabetes, immunosuppression, severe asthma etc. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary outcome will be apex formation |
primary outcome will be apex formation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| symptomatic relief |
with in a week |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
28/03/2017 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
non yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
the study is a randomized, parallel group, multiple arm trial comparing the clinical and radiographical evalution of 3 different apexification materials in patients with non vital immature permanent teeth. the study will be conducted in the department of Pediatric and Preventive Dentistry, King George Medical University , FODS, Lucknow.The primary outcome will be apex formation which will be evaluated after 3 months, 6 months, 9 months,12 months and 15 months post operatively. |