| CTRI Number |
CTRI/2023/03/051008 [Registered on: 23/03/2023] Trial Registered Prospectively |
| Last Modified On: |
22/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of MTA apical filling and full obturation of canal on healing of large periapical pathology. |
|
Scientific Title of Study
|
Comparative evaluation of healing of periapical lesions after MTA apexification and MTA obturation following non surgical root canal treatment of immature maxillary anterior teeth: A randomised control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prabhleen Kaur Brar |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Room No 101
Unit of Conservative Dentistry
Oral Health Sciences Centre,
PGIMER, Chandigarh
Room No 101
Unit of Conservative Dentistry
Oral Health Sciences Centre,PGIMER Chandigarh
Panchkula
HARYANA
134109
India |
| Phone |
09878030178 |
| Fax |
|
| Email |
prabhleen_brar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhleen Kaur Brar |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Room No 101
Unit of Conservative Dentistry
Oral Health Sciences Centre,
PGIMER, Chandigarh
Room No 101
Unit of Conservative Dentistry
Oral Health Sciences Centre,PGIMER Chandigarh
Panchkula
HARYANA
134109
India |
| Phone |
09878030178 |
| Fax |
|
| Email |
prabhleen_brar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabhleen Kaur Brar |
| Designation |
Assistant Professor |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Room No 101
Unit of Conservative Dentistry
Oral Health Sciences Centre,
PGIMER, Chandigarh
Room No 101
Unit of Conservative Dentistry
Oral Health Sciences Centre,PGIMER Chandigarh
Panchkula
HARYANA
134109
India |
| Phone |
09878030178 |
| Fax |
|
| Email |
prabhleen_brar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
PGIMER
SECTOR 12 CHANDIGARH |
| Type of Sponsor |
Research institution and hospital |
|
|
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 PRABHLEEN KAUR BRAR |
Post Graduate Institute of Medical Education and Research CHANDIGARH |
Room No. 101,
UNIT OF CONSERVATIVE DENTISTRY, ORAL HEALTH SCIENCES CENTRE
PGIMER CHANDIGARH
Chandigarh
CHANDIGARH |
09878030178
prabhleen_brar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with anterior teeth with open apex and periapical lesion |
| Patients |
(1) ICD-10 Condition: K004||Disturbances in tooth formation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Obturation and Apexification |
control group without obturation will be coronally sealed.Follow up will be done at 3,6 and 12 months. |
| Intervention |
Obturation and apexification |
MTA obturation and MTA apexification in anterior teeth with open apex will be done in one sitting.Follow up will be done at 3,6 and 12 months. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Maxillary/Mandibular anterior teeth with lesion size score of 4 as per CBCT
periapical index scores will be selected.
-Age group will be from 15-30 years.
|
|
| ExclusionCriteria |
| Details |
-pregnant patients
-patients with a history of therapeutic radiation to head and neck.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CBCT analysis of time taken for periapical healing with MTA apexification and obturation technique in open apex teeth with large periapical lesion. |
CBCT analysis of time taken for periapical healing with MTA apexification and obturation technique in open apex teeth with large periapical lesion.follow up will be done at 3,6 and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Periapical healing with MTA apexification in open apex teeth with large periapical lesion.
• Periapical healing with MTA obturation in open apex teeth with large periapical lesion.
|
3,6 and 12 months |
|
|
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)
|
20/04/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The prospective, randomized, double blinded study will be carried out on 30 nonvital, immature permanent maxillary incisor teeth randomly selected from dental OPD. Sample size determination is based on a level type I error at 0.05 and b level type II error of 0.20. We assume a dropout rate of approximately 15% and would enroll at least 10 subjects in each group. Diagnosis will be made based on the presence of sinus tract, spontaneous pain and/or pain to percussion or palpation. Periapical radiographs will be taken to confirm the presence of open apex and a periapical lesion. Then CBCT analysis will be done to note the size of the lesion. An informed written consent will be obtained from each subject. Samples will be allotted into three groups – Group I – 10 teeth obturated with MTA Group II- 10 teeth in which apexification will be done with MTA and the remaining canal will be obturated with thermoplasticised gutta percha. Group III-10 teeth as control (cleaning and shaping will be done but will not be obturated) The remaining canal will be obturated using thermaplasticized guttapercha points in group II after radiographic confirmation of the apical barrier whereas in group I, obturation will be carried out with MTA on same day. The access cavity will be restored with the temporary restorative material (Cavit™ ESPE, Cergy Pontoise, France) and radiograph will be taken to confirm the extension/condensation of MTA apical plug and obturation. The clinical and radiographic evaluation will be carried out at a follow up period of 3, 6 and12 months and success rate will be determined based upon the time duration required for periapical healing. Follow up will be done after 12 months using CBCT to note the time taken for healing. |