| CTRI Number |
CTRI/2019/02/017853 [Registered on: 27/02/2019] Trial Registered Prospectively |
| Last Modified On: |
27/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effects of two medicaments (MTA and 3Mixtatin) for the treatment of carious primary molars by vital pulp therapy
(pulpotomy). |
|
Scientific Title of Study
|
Comparative evaluation of the treatment outcomes of pulpotomy in primary molars using MTA and 3Mixtatin: A randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anam Mushtaq |
| Designation |
Post Graduate Student |
| Affiliation |
ITS Dental college Hospital and research centre. |
| Address |
ITS Dental College Hospital & Research Centre 47 Knowledge
Park 3 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
09958257560 |
| Fax |
|
| Email |
anam_a5@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mousumi Goswami |
| Designation |
HOD Department of pediatric dentistry ITS dental college Hospital & Research Centre |
| Affiliation |
ITS Dental college , hospital and research centre, Greater Noida, UP |
| Address |
ITS Dental College Hospital & Research Centre 47 Knowledge
Park 3 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
08588854190 |
| Fax |
|
| Email |
mousumi87goswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMousumi Goswami |
| Designation |
HOD Department of pediatric dentistry ITS dental college Hospital & Research Centre |
| Affiliation |
I.T.S Dental College Hospital and research centre. |
| Address |
I.T.S Dental College Hospital & Research Centre 47 Knowledge
Park 3 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
08588854190 |
| Fax |
|
| Email |
mousumi87goswami@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self
ITS Dental college , hospital and research centre Greater Noida |
|
|
Primary Sponsor
|
| Name |
Dr Anam Mushtaq |
| Address |
ITS dental college hospital and research centre Greater Noida |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Anam Mushtaq |
ITS dental college hospital and research centre Greater Noida |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anam Mushtaq |
ITS Dental college hospital and research centre |
I.T.S Dental College Hospital & Research Centre 47, Knowledge
Park-3 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India
Gautam Buddha Nagar
UTTAR PRADESH |
9958257560
anam_a5@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3MIXTATIN |
A powdered combination of 100mg ciprofloxacin, 100mg metronidazole , 100mg cefixime and 2 mg Simvastatin will be mixed with normal saline and delivered to radicular pulp stumps. |
| Comparator Agent |
MTA (Mineral Trioxide Aggregate) |
MTA mixed in putty like consistency will be placed on radicular pulp stumps. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Clinically:
1. History of localized pain lasting for a short duration which subsides upon elimination of causative mechanical or thermal stimulus.
2.Carious lesions involving more than half the dentin thickness.
3. Recent History of spontaneous pain of momentary duration not exceeding 7 days.
4. Hemorrhage control achievable within 3-5 minutes during the procedure.
5. Restorable crown structure
Radiographically
1. Carious lesion approximating pulp.
2. Absence of any periradicular or furcal pathology.
3. No pathologic external or internal root resorption. |
|
| ExclusionCriteria |
| Details |
Clinically:
1. History of lingering, Spontaneous and Nocturnal pain which is continuous even after removal of the stimuli.
2. Sensitivity to Hot Stimulus.
3. Tenderness on percussion.
4. Pathologic tooth mobility.
5. Vestibular obliteration and swelling in relation to the tooth
6. Draining sinus tract in relation to the tooth.
7. Grossly carious teeth with unrestorable crown structure.
Radiographically
1. Widened PDL space.
2. More than 1/3rd physiologic root resorption
3. Presence of periradicularor Periapical radiolucency.
4. Pathologic external or internal resorption
5. Calcifications within pulp |
|
|
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 |
Maintaining radicular pulp vitality and assessing it clinically by
(a)Absence of spontaneous pain and/or sensitivity to percussion and palpation, fistula / swelling, pathological mobility.
(b) Radiographic success by
Absence of periodontal ligament space widening , radiolucency at the periapical region, internal root resorption or external root resorption. |
3 months, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maintenance of tooth function and asymptomatic state |
At the end of 1 year ( 12 months) |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2019 |
| Date of Study Completion (India) |
10/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study was conducted in the Department of Pediatric and Preventive Dentistry, ITS Dental College, Hospital & Research Centre. 50 teeth were indicated for pulpotomy in 52 children. After obtaining written consent from their parents /guardians, 75 the teeth were divided into two equal groups (N=25). MTA and 3Mixtatin were used in the two groups. In both the groups, pulpotomy was performed and Clinical and radiographic evaluation was done after three months, six months and at the end of one year. The overall success rates of 3Mixtatin and MTA were found to be similar and statistically insignificant over the period of 1 year follow up. At the end of the study, the following conclusion was drawn: ï‚· no significant difference in the overall success rates of pulpotomy procedure using MTA and 3Mixtatin over a follow-up period of one year when used for the management of deeply carious primary teeth with no clinical/radio-graphic signs or symptoms of irreversible pulp inflammation. ï‚· no statistically significant difference in clinical and radiographic success of MTA and 3Mixtatin at 3rd month, 6th month and at the end of one year. ï‚· PDL widening was the common radiographic failure in both the groups i.e MTA and 3mixtatin. ï‚· no clinically significant difference in the overall success rate between maxillary and mandibular primary molars.
|