| CTRI Number |
CTRI/2018/07/014785 [Registered on: 10/07/2018] Trial Registered Retrospectively |
| Last Modified On: |
09/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect of new medicament to save the primary teeth. |
|
Scientific Title of Study
|
An evaluation of nano-hydroxyapatite as a pulpotomy
medicament in primary teeth.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monika Grewal |
| Designation |
Junior Resident |
| Affiliation |
Faculty of Dental Sciences,KGMU |
| Address |
Department of Paediatric and Preventive Dentistry,
King George’s Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7054473661 |
| Fax |
|
| Email |
monikagrewal16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Singh |
| Designation |
Associate Professor |
| Affiliation |
Faculty of Dental Sciences,KGMU |
| Address |
Department of Paediatric and Preventive Dentistry,
King George’s Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9450849528 |
| Fax |
|
| Email |
rajkids2000@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Grewal |
| Designation |
Junior Resident |
| Affiliation |
Faculty of Dental Sciences,KGMU |
| Address |
Department of Paediatric and Preventive Dentistry,
King George’s Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7054473661 |
| Fax |
|
| Email |
monikagrewal16@gmail.com |
|
|
Source of Monetary or Material Support
|
| self
Dr Monika Grewal
Junior resident |
|
|
Primary Sponsor
|
| Name |
Dr Monika Grewal |
| Address |
Department of Paediatric and Preventive Dentistry
King Georges Medical University Lucknow |
| Type of Sponsor |
Other [] |
|
|
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 Monika Grewal |
King George’s Medical University, Lucknow |
Outpatient Department of Paediatric and Preventive Dentistry,KGMU
Lucknow
UTTAR PRADESH |
7054473661
monikagrewal16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Ethics Committee,KGMU,lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Healthy patients with deep carious primary molars., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mineral Trioxide Aggregate |
MTA ANGELUS white, Brasil
reparative cement.
setting time 15 minutes |
| Intervention |
Nano hydroxyapaptite
Calicum hydroxide with 3% Nano-hydroxyapatite
Mineral Trioxide Aggregate
|
Calcium hydroxide, Azure laborateries
Hydroxylapatite nanoparticles,Nanobeach
white nanopowder, 40nm |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
symptom-free deep carious mandibular primary molar tooth with vital pulp,
sufï¬cient tooth structure for restoration with a stainless steel crown,
no history of spontaneous pain,
no clinical evidence of extensive pulp degeneration or periapical pathology,including tenderness to percussion, tooth mobility, abscess, ï¬stula, or swelling of the gingiva,
no radiographic evidence of periapical pathosis or inter-radicular bone loss,internal resorption, pulp calcification, ankylosis, or pathologic external root resorption.
Physiologic root resorption, while included in the criteria, could not be more than one-third of the root length.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria included the presence of any systemic pathology
any history of allergic reaction to latex, local anesthetics or to the constituents of the tested pulp dressing agents.
Clinical or radiographic sign or symptoms of pulp degeneration(i.e. spontaneous pain, excessive bleeding from the root canal,inter-radicular and/or periapical bone destruction)
|
|
|
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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
No clinical sign of pulp degeneration
No radiographic sign of root and bone resorption |
Timepoints of measuring primary outcome is 3 months, 6 months, 9 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The restoration performance (partially or completely lost fillings, secondary caries at the margin, perforated or lost Stainless Steel crowns, severe Gingival inflammation) |
Timepoints of measuring secondary outcome is 3 months,6 months, 9 months. |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
17/12/2014 |
| 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="8"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Despite modern advances in the prevention of
dental caries and increased understanding of the importance of maintaining the
natural primary dentition, many teeth are still lost prematurely. Pulpotomy has remained an acceptable and mainstay treatment in
preserving the vitality of the primary tooth and prolonging its life till the
permanent successor erupts. The present study is a randomized, double blind, parallel group, active controlled trial to
evaluate and compare the
efficacy, both clinically and radiographically, of our new medicament Nano-hydroxyapatite and calcium hydroxide with 3% Nano-hydroxyapatite with the standard material MTA for pulpotomy.
|