| CTRI Number |
CTRI/2024/07/071412 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The effect of Root Canal Treatment to reduce the pain on nearby and opposite healthy teeth on same arch-A clinical study |
|
Scientific Title of Study
|
The effect of Root Canal Treatment on the resolution of mechanical allodynia in healthy adjacent and contralateral teeth: A prospective clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sufina mohammad sirajudheen |
| Designation |
junior resident |
| Affiliation |
All India Institute of Medical Science and Research,New Delhi |
| Address |
Third floor,CDER,Ansari nagar,AIIMS -New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9567123442 |
| Fax |
|
| Email |
sufinams@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar |
| Designation |
additional proffessor |
| Affiliation |
All India Institute of Medical Science and Research,New Delhi |
| Address |
Room no: 308,Third floor,CDER,Ansari nagar,AIIMS -New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9540055001 |
| Fax |
|
| Email |
kumarvijay29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sufina mohammad sirajudheen |
| Designation |
junior resident |
| Affiliation |
All India Institute of Medical Science and Research,New Delhi |
| Address |
Third floor,CDER,Ansari nagar,AIIMS -New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9567123442 |
| Fax |
|
| Email |
sufinams@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI,INDIA,110029 |
|
|
Primary Sponsor
|
| Name |
CENTRE FOR DENTAL EDUCATION AND RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
CENTRE FOR DENTAL EDUCATION AND RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI-110029 |
| 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 |
| sufina mohammad sirajudheen |
All india institute of medical science |
Room 315,Third floor,Division of Conservative Dentistry, CDER,Ansari Nagar,AIIMS New Delhi-110029
New Delhi
DELHI |
9567123442
sufinams@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES ANSARI NAGAR, NEW DELHI 110029 |
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 |
NON-SURGICAL ENDODONTIC THERAPY |
After clinical and radiographic assessment, the patient will be requested to rinse the oral cavity with 10 ml. of 0.2% chlorhexidine di-gluconate. The tooth will be anesthetised with 2% Lidocaine with 1:80,000 epinephrine and isolated with a rubber dam. Access opening will be done with high-speed bur under water coolant. Pulp chamber will be flushed with distilled water. The working length will be determined with electronic apex locater operated as per manufacturer’s recommendations .The canal is minimally instrumented (glide path)up to the working length with ISO 0.02 taper #06-20K and the preparation of the canal will be carried out with the use of ProTaper® Gold Rotary Files .Entire instrumentation will be supplemented with copious irrigation of canal with 5.25%NAOCL.The canal will be irrigated with 17% EDTA for 1min and the final flush will be done with distilled water. The canal will be dried with sterile adsorbent paper point and to be obturated using AH plus and Calamus Dual Thermoplasticized Gutta-Percha.The access cavity will be sealed with a tooth coloured resin restorative material. Post obturation IOPA is to be taken and Final restoration with composite resin restoration will be done to complete the procedure on same visit as per standard restorative protocol at division of Conservative Dentistry ,Total intervention duration will be 30 minutes and Follow up for 6months will be done. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 Mandibular 1 and 2nd molar with severe pulpitis.
2 IOPA Periapical index score ≤2
3 The presence of an adjacent (mesial and distal) and contralateral teeth with vital pulp.
4 VAS score ≥45mm for diseased tooth and VAS score ≥5mmfor healthy adjacent and contralateral.
|
|
| ExclusionCriteria |
| Details |
1 Test teeth forming part of a fixed partial prosthesis
2 Persistent use of medication (e.g., analgesics, steroids, or antidepressants>7days that might alter the pain thresholds.
3 Teeth with immature roots, Current orthodontic treatment, Teeth with subgingival caries, cracks, cusp fractures, poor periodontal health.
4 Patient with non-odontogenic tooth pain
5 Presence of Acute /chronic apical abscess.
6 Patients with systemic conditions which could compromise the healing
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate percussion sensitivity and mechanicla allodynia |
24 hours,7days,1month,3month and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3. To compare the pre and postoperative intensity of mechanical allodynia in
D. Tooth with severe pulpitis
E. Healthy adjacent teeth
F. Healthy contralateral tooth
|
24 hours, 7 days, 1 month, 3 months and 6 months follow-ups
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
After clinical and radiographic assessment, the patient will be requested to rinse the oral cavity with 10 ml. of 0.2% chlorhexidine di-gluconate. The tooth will be anesthetised with 2% Lidocaine with 1:80,000 epinephrine and isolated with a rubber dam. Access opening will be done with high-speed bur under water coolant. Pulp chamber will be flushed with distilled water. The working length will be determined with electronic apex locater operated as per manufacturer’s recommendations .The canal is minimally instrumented (glide path)up to the working length with ISO 0.02 taper #06-20K and the preparation of the canal will be carried out with the use of ProTaper® Gold Rotary Files .Entire instrumentation will be supplemented with copious irrigation of canal with 5.25%NAOCL.The canal will be irrigated with 17% EDTA for 1min and the final flush will be done with distilled water. The canal will be dried with sterile adsorbent paper point and to be obturated using AH plus and Calamus Dual Thermoplasticized Gutta-Percha.The access cavity will be sealed with a tooth coloured resin restorative material. Post obturation IOPA is to be taken and Final restoration with composite resin restoration will be done to complete the procedure on same visit as per standard restorative protocol at division of Conservative Dentistry and Endodontics. |