| CTRI Number |
CTRI/2024/10/074776 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain after root canal treatment with different techniques. |
|
Scientific Title of Study
|
Evaluation of post-obturation pain after using different obturation techniques in patients undergoing root canal treatment- a randomized controlled trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavalipurapu Venkata Teja |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Saveetha Dental College
Poonamale high road
Chennai
Tamilnadu
Chennai TAMIL NADU 600077 India |
| Phone |
9751933999 |
| Fax |
|
| Email |
metejaendo@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kavalipurapu Venkata Teja |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Saveetha Dental College
Poonamale high road
Chennai
Tamilnadu
Chennai TAMIL NADU 600077 India |
| Phone |
9751933999 |
| Fax |
|
| Email |
metejaendo@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kavalipurapu Venkata Teja |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Saveetha Dental College
Poonamale high road
Chennai
Tamilnadu
Chennai TAMIL NADU 600077 India |
| Phone |
9751933999 |
| Fax |
|
| Email |
metejaendo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College & Hospitals, Chennai, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Kavalipurapu Venkata Teja |
| Address |
Saveetha Dental College & hospitals, Poonamalle high road, Vellapanchavadi, Chennai, TamilNadu, India Pin code: 600077 |
| 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 Kavalipurapu Venkata Teja |
Saveetha Dental College |
Chennai, TamilNadu, India Chennai TAMIL NADU |
9751933999
metejaendo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Symptomatic irreversible pulpitis |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cold lateral compaction |
the patients in this group underwent root canal obturation using lateral condensation. Here after root canal preparation, cleaning and drying, thr master cone was confirmed with x-ray. followed by sequential accessory cones placed and lateral compactions given using a spreader. finally, the gutta-percha was cut and the access cavity was sealed. |
| Intervention |
Continous wave compaction |
after the complete root canal shaping, cleaning and drying, the patients in this group underwent obturation after placing matched taper cone in canal, which is confirmed with an x-ray. After specific confirmation, the gutta-percha was warm vertically compacted and the rest of the canal was backfilled with thermoplastic gutta-percha. the orifice was then selaed with composite. |
| Intervention |
Modifed heat technique |
After the root canal shaping, cleaning and drying, the patients in this group underwent obturation using matched single cone. however, the temperature for shearing the gutta-percha and warm vertical condensations was set to 120-degree Celsius using a electric heated plugger. after warm vertical condensations, the orifice of access was sealed using composite. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants included were between the age group of 18 to 60, who requires endodontic therapy for molars and premolars that were diagnosed as symptomatic irreversible pulpitis. |
|
| ExclusionCriteria |
| Details |
Participants who were medically compromised, pregnant woman, antibiotic therapy, teeth with incomplete apex formation, calcified canals, periapical abscess, and sinus opening were excluded for the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain |
12 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="63" Sample Size from India="63"
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 3 |
|
Date of First Enrollment (India)
|
12/10/2024 |
| 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="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will adopt a prospective, single centered, randomized controlled clinical trial method to meet the objectives. Participants included will be between the age group of 18 to 60, who requires endodontic therapy for molars and premolars that were diagnosed as symptomatic/asymptomatic irreversible pulpitis with apical periodontitis. Participants who were medically compromised, pregnant woman, antibiotic therapy, teeth with incomplete apex formation, calcified canals, periapical abscess, and sinus opening will be excluded for the study. The study participants will be recruited from the pool of patients in the Department of Conservative Dentistry and Endodontics at Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, India. The sample size estimation was calculated using a priori by G-power (3.0.10). The minimum sample size of each group was calculated, following these input conditions. The total sample size obtained was 57 samples with 19 samples per group. In order to compensate the drop out, sample size was kept at 63 (21 samples per group). Block randomizationwill be done well in advance by a third person who was not related to the study using block of 9, of which number 2, 4, 5 assigned to Group I –Cold Lateral Compaction, number 1, 3, 7 to Group II – Modifed heat technique, and number 6, 8, 9 to Group III –Continuous Wave Compaction. SNOSE (sequentially numbered, opaque, sealed envelopes) method will be implemented for allocation concealment which conceals the sequence until interventions were assigned. A piece of paper containing randomized group number will be sealed in the dark coloured envelope containing respective serial number over it prepared by a third person. The group is mentioned clearly and sealed in the envelope. Patients will be assigned their study numbers as they sequentially entered the study. The envelope was opened once the intervention was assigned. Based on the group assigned in the paper, respective treatment was carried out. |