| CTRI Number |
CTRI/2024/09/073957 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Passive Ultrasonic irrigation on postoperative pain in diabetic patients after Endodontics treatment |
|
Scientific Title of Study
|
Effect of Passive Ultrasonic Irrigation on Post operative pain in controlled diabetic patients after non surgical Endodontic treatment of teeth - A randomised 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 |
Monika Tandan |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College
SURAJKUND road
Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9999063631 |
| Fax |
|
| Email |
drmonikatandan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monika Tandan |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College
SURAJKUND road
Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9999063631 |
| Fax |
|
| Email |
drmonikatandan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika Tandan |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College
SURAJKUND road
Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9999063631 |
| Fax |
|
| Email |
drmonikatandan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College
Delhi Surajkund Road
Faridabad
Haryana 121004
India |
|
|
Primary Sponsor
|
| Name |
Monika Tandan |
| Address |
Manav Rachna Dental College
Surajkund Road
Faridabad |
| 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 |
| Dr Monika Tandan |
Manav Rachna Dental College |
QS 26
Q block
Department of Conservative Dentistry and Endodontics
Faridabad
Faridabad
HARYANA |
9999063631
drmonikatandan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional syringe irrigation |
27 gauge conventional syringe will be used in the control group for 30 sec once |
| Intervention |
Passive Ultrasonic irrigation |
Canals will be irrigated with 5ml of 5.25% NaOCl solution and passively activated with ultrasonic tip for 30 sec 2 mm short of the working length once
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who had not taken analgesics on anti-inflammatory drugs within the last 12 hours
Patients diagnosed with symptomatic irreversible pulpitis in maxillary and mandibular posterior teeth |
|
| ExclusionCriteria |
| Details |
Patients who had taken analgesics on anti-inflammatory drugs within the last 12 hours
Pregnant women and patients with immunocompromised health state
Patients having severe malocclusion associated with traumatic occlusion
Teeth with calcified canals
Teeth with periapical radiolucency
Teeth with root resorption
Teeth previously undergone root canal treatment
Teeth with vertical or horizontal root fracture
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of post operative pain |
Evaluation of post operative pain at 6, 24, 48, 72 hours and 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/09/2024 |
| Date of Study Completion (India) |
11/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
´The incidence of postoperative pain after endodontic treatment ranges from 1.9%-48%. This pain is often attributed to periapical inflammatory responses which typically subsided over time but occasionally persisting for several days. ´Two factors that affect the postoperative pain are: 1. During pulp necrosis, the bacterial toxins and immunological agents reach the peri radicular tissues leading to apical periodontitis (AP). 2. There are some systemic conditions that increases the susceptibility of the host to infection thereby increasing microorganisms in AP. ´It is important to consider these factors in order to ensure effective implementation of pain management strategies in the context of endodontic interventions. ´Animal and epidemiological studies have provided the data suggesting that several systemic conditions like diabetes, cardiovascular diseases, smoking, menopause, HIV and others can substantially influence the prognosis of endodontic treatment. ´Most common systemic factor affecting post-operative pain is Diabetes Mellitus affecting more than 9% of the population. ´Several etiologic factors are attributed to postoperative pain (PP) including a history of preoperative pain, periapical disease, and extrusion of debris and/or irrigation solution into the periapical tissue. ´Materials extruded into the periapical tissue have been suggested as a major source of pain after RCT. It has been stated that irrigation methodologies and devices have an effect on apical extrusion of debris and irrigants. ´Several studies have evaluated the healing outcomes and post operative pain in diabetic patients but so far no study has evaluated the effect of passive ultrasonic irrigation on post operative pain of diabetic patients after endodontic treatment of teeth with symptomatic apical periodontitis. |