| CTRI Number |
CTRI/2022/06/043569 [Registered on: 29/06/2022] Trial Registered Prospectively |
| Last Modified On: |
28/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of results of revascularization in immature non-vital permanent teeth using the calcium hydroxide and triple antibiotic paste as an medicament- A pilot study |
|
Scientific Title of Study
|
A Randomized clinical trial comparing the outcomes of revascularization in immature non-vital permanent teeth using the calcium hydroxide and triple antibiotic paste as an intracanal medicament- A pilot exploratory study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC-330 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Morankar Rahul |
| Designation |
Assistant professor |
| Affiliation |
AIIMS New Delhi |
| Address |
608, Center for Dental Education and research, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9855501651 |
| Fax |
|
| Email |
drmorankarrahul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Morankar Rahul |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
608, Center for Dental Education
and Research, AIIMS,New DElhi
Dental department, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9855501651 |
| Fax |
|
| Email |
drmorankarrahul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitesh Tewari |
| Designation |
Associate Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
608, Center for Dental Education and research, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
dr.nitesht@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Morankar Rahul |
| Address |
CDER AIIMS NEW DELHI |
| Type of Sponsor |
Other [Self funding] |
|
|
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 Morankar Rahul |
AIIMS NEW DELHI |
Room 608 Pedodontics and Preventive Dentistry CDER AIIMS NEW DELHI
New Delhi
DELHI |
9855501651
drmorankarrahul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics commitee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calcium Hydroxide medicament |
Regenerative endodontic procedure using Calcium hydroxide medicament for 4 weeks |
| Comparator Agent |
Triple antibiotic paste as an medicament |
Regenerative Endodontic Procedure using Triple antibiotic paste as an medicament for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Participant’s age should be 14 years or less
2. Immature non-vital permanent teeth as a result of trauma or dental caries
3. Teeth should be in nollas stage 7, 8 or 9 of tooth development
4. Consent for participation and willingness for the treatment.
|
|
| ExclusionCriteria |
| Details |
1. Denied consent or not willing for participation
2. Presence of any systemic/hematological disorder that can affects outcome of the procedure
3. Patient is allergic to calcium hydroxide or triple antibiotic paste
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical success of revascularization procedure in immature non-vital permanent teeth using the calcium hydroxide and triple antibiotic paste as an intracanal medicament |
3, 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the radiographic success of revascularization procedure in immature non-vital permanent teeth using the calcium hydroxide and triple antibiotic paste as an intracanal medicament
2. To evaluate and compare the pulp vitality outcomes of revascularization using calcium hydroxide and triple antibiotic paste as an intracanal medicament
|
6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
05/07/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/07/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [captainrahul88@gmail.com].
- For how long will this data be available start date provided 05-07-2022 and end date provided 21-04-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Revascularization is a regenerative treatment
modality which has been advocated for management immature non-vital permanent
teeth. It can lead to root development, thickening of dentinal walls and
reestablishment of vitality. Root canal disinfection is a pre-requisite for any
regenerative endodontic procedure for which intracanal medicaments have been
found very crucial role. Thus, this research is planned to assess the outcomes of
revascularization in immature non-vital permanent teeth using the calcium
hydroxide and triple antibiotic paste as an intracanal medicament. The Aim was to evaluate the
outcomes of revascularization in immature non-vital permanent teeth using the
calcium hydroxide and triple antibiotic paste as an intracanal medicament- The
objective was to clinically and radiographically
evaluate the outcomes of revascularization in immature non-vital
permanent teeth using the calcium hydroxide and triple antibiotic paste as an
intracanal medicament. This study will be carried out in the Division of Pedodontics and
Preventive Dentistry, CDER, AIIMS, New Delhi. The Study duration was 2 years
and sample size was T]total 20 teeth (10 in each group). The treatment plan and
prognosis would be explained to the parents and a written informed consent will
be obtained. In the first visit, after access cavity will be prepared. Canals
would be irrigated followed by placement of intracanal medicament. Random
allocation would be done using computer-generated sealed envelope technique into
two groups 1. Calcium hydroxide 2. Triple antibiotic paste. For the second
visit, the patient will be recalled after 2 weeks to evaluate the clinical
signs and symptoms. Intracanal medicament would be removed followed by
induction of bleeding into the root canal to allow the clot formation to occur
followed placement of MTA over the blood clot and final restoration. For
follow-up clinical evaluation- patient will be assessed for clinical signs and
symptoms at 3,6 and 12 months. Radiographic evaluation- Patient will be
assessed for increase in root length and root width and resolution of
preoperative radiolucency at 3, 6 and 12 months. Vitality assessment-Vitality
testing will be done at 3, 6 and 12 months postoperatively.
|