| CTRI Number |
CTRI/2023/04/051817 [Registered on: 20/04/2023] Trial Registered Prospectively |
| Last Modified On: |
19/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
clinical and radiographical success of root canal treatment using injectable MTA as a root canal sealer for permanent teeth in pediatric patients. |
|
Scientific Title of Study
|
clinical efficacy of root canal treatment using single cone technique with injectable MTA as a root canal sealer- An in vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarnalatha A |
| Designation |
post graduate student |
| Affiliation |
karpaga vinayaga institute of dental sciences |
| Address |
Department of Pedodontics and preventive dentistry,room no 8( 4th floor), Division of dental hospital,ROAD, CHINNA KOLAMBAKKAM, PALAYANOOR (PO), CHENGALPATTU (DT) 603 308 MADHURANTHAGAM(TK)
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
8940929916 |
| Fax |
|
| Email |
dr.swarnalatha.bds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swarnalatha A |
| Designation |
post graduate student |
| Affiliation |
karpaga vinayaga institute of dental sciences |
| Address |
Department of Pedodontics and preventive dentistry,room no 8( 4th floor), Division of dental hospital,ROAD, CHINNA KOLAMBAKKAM, PALAYANOOR (PO), CHENGALPATTU (DT) 603 308 MADHURANTHAGAM(TK),
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
8940929916 |
| Fax |
|
| Email |
dr.swarnalatha.bds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vignesh guptha |
| Designation |
Reader |
| Affiliation |
karpaga vinayaga institute of dental sciences |
| Address |
Department of Pedodontics and preventive dentistry,room no 8( 4th floor), Division of dental hospital,ROAD, CHINNA KOLAMBAKKAM, PALAYANOOR (PO), CHENGALPATTU (DT) 603 308 MADHURANTHAGAM(TK),
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9840485769 |
| Fax |
|
| Email |
vigneshguptha88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga vinayaga institute of dental sciences and hospital |
|
|
Primary Sponsor
|
| Name |
DR.A.SWARNALATHA |
| Address |
Old no 80 new no 585, mkn road,alandur,chennai |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Swarnalatha |
karpaga vinayaga institute of dental sciences |
Department of
Pedodontics and
preventive
dentistry,room no 8( 4th
floor), Division of dental
hospital,ROAD,
CHINNA
KOLAMBAKKAM,
PALAYANOOR (PO),
CHENGALPATTU (DT)
603 308 MADHURANT
HAGAM(TK),
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
8825826290
dr.swarnalatha.bds@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC - KIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AH Plus |
currently used Resin based Endodontic Sealer which is placed permanently within root canals of teeth
duration : sealer is placed permanently in patients teeth |
| Comparator Agent |
ENDOSEAL MTA |
Bio ceramic sealer based on pozzolan cement placed permanently within tooth
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Tender on percussion
Severe pain (nocturnal pain)
Discoloured non vital tooth
Decay involving pulp
Age between 8 – 13 years
|
|
| ExclusionCriteria |
| Details |
Decay with furcation involvement
Mobility
Unrestorable crown
Children with special health care needs
Patients who refused to participate
Retreatment of root canals
Patients who initiated root canal treatment in other clinics.
Radiographically - Pulpal calcification
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Periapical Healing after root canal
treatment(Radiographic evaluation) |
At 1 month and 3 months followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post obturation pain (post treatment pain)
|
4, 24 and 72 hours and after 7 days
follow up |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
29/04/2023 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: For the longevity of the root canal-treated permanent teeth, essential steps are cleaning, shaping, and providing three-dimensional obturation of the root canal system. Obturation should be an antibacterial, fluid-impervious seal essential for the success of root canal treatment. using MTA for obturation provides less inflammatory and non inflammatory changes seen in invitro studies. Based on this our study was performed considering the apex of young permanent teeth and wide canal, along with very few in-vivo studies on injectable premixed MTA as a root canal sealer. Aims: Evaluation of Post obturation pain after 4, 24 & 72 hours using Visual Analogue Scale (VAS) and tactile examination after seven days. Radiographic success evaluation based on a periapical index (PAI Score) after one month and three months. Settings and Design: Methods and Material: Root canal treatment was performed in human young permanent teeth using injectable premixed MTA as a sealer with gutta-percha as an obturating material within the age group of 8 to 13 years. Measurement of postoperative Pain and periapical index score (PAI) will be evaluated.
|