| CTRI Number |
CTRI/2021/04/033217 [Registered on: 28/04/2021] Trial Registered Prospectively |
| Last Modified On: |
27/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
THE EFFECT OF MAINTAINING APICAL PATENCY ON POST OPERATIVE PAIN |
|
Scientific Title of Study
|
To assess effect of maintaining apical patency on post operative pain in posterior teeth: A Prospective Randomised 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 |
POOJA YADAV |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
BHARATI VIDYAPEETH DENTAL COLLEGE |
| Address |
Room no 302, 3rd floor Department of conservative dentistry and
endodontics Bharati vidyapeeth dental college Navi mumbai
Raigarh
Mumbai
MAHARASHTRA
410210
India |
| Phone |
07275943338 |
| Fax |
|
| Email |
poojarocks0806@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHISH JAIN |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
BHARATI VIDYAPEETH DENTAL COLLEGE |
| Address |
room no 302, 3rd floor department of conservative dentistry and
endodontics bharati vidyapeeth dental college navi mumbai
Raigarh
Mumbai
MAHARASHTRA
410210
India |
| Phone |
09653695620 |
| Fax |
|
| Email |
drakjain5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
POOJA YADAV |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
BHARATI VIDYAPEETH DENTAL COLLEGE |
| Address |
room no 302, 3rd floor department of conservative dentistry and endodontics bharati vidyapeeth dental college navi mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
07275943338 |
| Fax |
|
| Email |
poojarocks0806@gmail.com |
|
|
Source of Monetary or Material Support
|
| room no 302, 3rd floor bharati vidyapeeth dental college cbd belapur navi mumbai |
|
|
Primary Sponsor
|
| Name |
Pooja yadav |
| Address |
DEPT OF CONSERVATIVE DENTISTRY& ENDODONTICS,BHARATI VIDYAPEETH DENTAL SECTOR 7 BELAPUR, NAVI MUMBAI |
| 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 |
| Pooja yadav |
BHARATI VIDYAPEETH DENTAL COLLEGE |
ROOM NO 302 3RD
FLOOR DEPT OF
CONSERVATIVE AND
ENDODONTICS
BHARATI
VIDYAPEETH DENTAL
COLLEGE SECTOR 7
BELAPUR NAVI
MUMBAI
Mumbai
MAHARASHTRA |
8726162936
poojarocks0806@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Symptomatic Apical Periodontitis |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
APICAL PATENCY GROUP |
APICAL PATENCY IS MAINTAINED USING 10 NO K FILE DURING BIOMECHANICAL PREPARATION |
| Comparator Agent |
NON APICAL PATENCY GROUP |
APICAL PATENCY IS NOT MAINTAINED DURING BIOMECHANICAL PREPARATION IN THIS GROUP |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients age 21 years and above of either gender.
2)Healthy co-operative adults were taken in the study who were willing to participate. Only patients requiring endodontic treatment with vital maxillary or mandibular posterior teeth with irreversible pulpitis were included.
|
|
| ExclusionCriteria |
| Details |
1)Patients with non-vital pulp.
2)Presence of complications during treatment (impossibility to achieve apical
patency in any canal, calcified canals).
3)Medically compromised mentally challenged adults.
4)Pregnancy or breast feeding.
5)Cases of grossly decayed teeth where rubber dam isolation was difficult.
6)Re treatment cases.
7)Use of anti-inflammatory analgesics and psychotropic drugs over 3 months.
8)Patients with restricted mouth opening.
9)Patients who have taken medication for pre-operative pain.
10)Failure to obtain patients consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of post-operative pain in posterior vital teeth with irreversible pulpitis maintaining apical patency |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the intensity of post-operative pain with and without
maintaining apical patency in posterior vital teeth with irreversible
pulpitis. |
7 days |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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 1 |
|
Date of First Enrollment (India)
|
04/05/2021 |
| 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="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Background: The concept of instrumentation beyond the apical foramen i.e. maintaining apical patency(AP) by a small flexible file to prevent blockage is a controversial issue in endodontics. However, maintaining patency might endow postoperative pain, thus the matter of dilemma is to maintain apical patency or not. Aim: Aim of the study is to evaluate pain the association between apical patency and post-operative pain in posterior vital teeth with irreversible pulpitis. The primary objective of the study was to evaluate the incidence and compare intensity of post-operative pain with and without maintaining apical patency in posterior vital teeth with irreversible pulpitis. Materials and Methods: One hundred twelve patients were included in the study. Patients were randomly divided into: Group A (n = 56) contained apical patency maintaining group and Group B (n = 56) contained those treated without maintaining apical patency. Incidence of post-operative pain of patient was recorded on 1st day (24hrs), 2nd day (48hrs), and 7th day using Visual Analog Scale (VAS). Results: There was no statistically significant difference between the pain scores in both the groups on Day 1, Day 2 and Day 7. Pain intensity is maximum in Day 1 and least in Day 7.
Conclusion: Maintenance of apical patency during biomechanical preparation had no significant influence on post-operative pain in posterior teeth with vital pulps in irreversible pulpitis cases. |