| CTRI Number |
CTRI/2022/01/039767 [Registered on: 27/01/2022] Trial Registered Prospectively |
| Last Modified On: |
28/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Postoperative pain evaluation using 2shape files in two different motions after single visit root canal treatment. |
|
Scientific Title of Study
|
Comparative evaluation of postoperative pain after single-visit endodontics using 2shape files in rotary and adaptive motion- A double-blinded 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 |
Sayisree Yarlagadda |
| Designation |
Post graduate |
| Affiliation |
Meenakshi Ammal Dental College |
| Address |
Department of Conservative Dentistry and Endodontics, Meenakshi Ammal Dental College and Hospital, Janaki nagar, Alapakkam main road, Maduravoyal, Chennai.
Chennai
TAMIL NADU
600095
India |
| Phone |
9008411996 |
| Fax |
|
| Email |
sayisreeyarlagadda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandini Suresh |
| Designation |
Professor |
| Affiliation |
Meenakshi Ammal Dental College and Hospital, Chennai. |
| Address |
Department of Conservative Dentistry and Endodontics, Meenakshi Ammal Dental College and Hospital, Janaki nagar, Alapakkam main road, Maduravoyal, Chennai.
Chennai
TAMIL NADU
600095
India |
| Phone |
9884292850 |
| Fax |
|
| Email |
nandini_80@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandini Suresh |
| Designation |
Professor |
| Affiliation |
Meenakshi Ammal Dental College |
| Address |
Department of Conservative Dentistry and Endodontics, Meenakshi Ammal Dental College and Hospital, Janaki nagar, Alapakkam main road, Maduravoyal, Chennai.
Chennai
TAMIL NADU
600095
India |
| Phone |
9884292850 |
| Fax |
|
| Email |
nandini_80@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Sayisree Yarlagadda |
| Address |
Department of Conservative Dentistry and Endodontics, Meenakshi Ammal Dental College and Hospital, Janaki nagar, Alapakkam main road, Maduravoyal, Chennai. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sayisree Yarlagadda |
Meenakshi Ammal Dental College and Hospital (Department of Conservative Dentistry and Endodontics) |
Janaki nagar, Alapakkam main road, Maduravoyal, Chennai- 600095
Chennai
TAMIL NADU |
9008411996
sayisreeyarlagadda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Meenakshi Academy of Higher Education and Research, Chennai, Tamil Nadu, India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2Shape files in Adaptive motion |
The canals will be instrumented using 2Shape file in adaptive motion in the sequence of TS1 (#25 .04) and TS2 (#25 .06) |
| Comparator Agent |
2Shape files in Rotary motion |
The canals will be instrumented using 2Shape file in rotary motion in the sequence of TS1 (#25 .04) and TS2 (#25 .06) in three waves with upward circumferential filing movement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients with permanent maxillary and mandibular molars diagnosed with symptomatic irreversible pulpitis and apical periodontitis, teeth with moderate sharp spontaneous pain or pain stimulated with hot or cold with lingering response even after removal of the stimulus, teeth with tenderness to percussion and no periapical lesions will be included. |
|
| ExclusionCriteria |
| Details |
Teeth with crown/root fractures, acute or chronic apical abscess, pulp necrosis, compromised periodontium and open apices, patients who cannot interpret the VAS, medically compromised patients, pregnant and lactating women, history of allergy to local anesthetic solutions, or any drugs, on long-term medications that influenced pain threshold, analgesics, steroids and /or antibiotics in the recent past 24 hours, teeth with necrotic pulp after access cavity preparation will be excluded. |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence and intensity of post-operative pain following single-visit root canal treatment with regards to usage of 2Shape file in both rotary and adaptive motion. |
6h, 12h, 24h, 48h, 72h using a VAS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Influence of gender, age, and type of tooth on postoperative pain. |
6h, 12h, 24h, 48h, 72h |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/02/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present clinical trial aims to assess the postoperative pain following the single-visit endodontic treatment using 2shape files in two different motion systems. i.e., rotary and twisted adaptive motion. The primary outcome is to measure the incidence and intensity of pain at 6h,12h,24h,48h, and 72h postoperatively. The secondary outcomes are gender, age and type of tooth on postoperative pain. |