| CTRI Number |
CTRI/2022/02/040315 [Registered on: 15/02/2022] Trial Registered Prospectively |
| Last Modified On: |
11/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of pain following ozonated chlorhexidine and octinidine irrigation in endodontic retreatment. |
|
Scientific Title of Study
|
Evaluation of efficacy of ozonated and non-ozonated 2% Chlorhexidine gluconate and 0.1% Octinidine hydrochloride with and without hypochlorite application in single visit endodontic retreatment: A 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 |
Nidhi Sinha |
| Designation |
Professor |
| Affiliation |
PACIFIC DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of conservative dentistry and endodontics
Pacific dental college and hospital Airport road Debari
Udaipur
RAJASTHAN
313024
India
Department of conservative dentistry and endodontics
Pacific dental college and hospital Airport road Debari
Udaipur
RAJASTHAN
313024
India
Udaipur
RAJASTHAN
842001
India |
| Phone |
08619423478 |
| Fax |
|
| Email |
dr.nidhi.sinha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Sinha |
| Designation |
Professor |
| Affiliation |
PACIFIC DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of conservative dentistry and endodontics
Pacific dental college and hospital Airport road Debari
Udaipur
RAJASTHAN
313024
India
Department of conservative dentistry and endodontics
Pacific dental college and hospital Airport road Debari
Udaipur
RAJASTHAN
313024
India
Udaipur
RAJASTHAN
842001
India |
| Phone |
08619423478 |
| Fax |
|
| Email |
dr.nidhi.sinha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Sinha |
| Designation |
Professor |
| Affiliation |
PACIFIC DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of conservative dentistry and endodontics
Pacific dental college and hospital Airport road Debari
Udaipur
RAJASTHAN
313024
India
Department of conservative dentistry and endodontics
Pacific dental college and hospital Airport road Debari
Udaipur
RAJASTHAN
313024
India
Udaipur
RAJASTHAN
842001
India |
| Phone |
08619423478 |
| Fax |
|
| Email |
dr.nidhi.sinha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific dental college and hospital Airport road Debari
Udaipur Rajasthan
RAJASTHAN
313024
India |
|
|
Primary Sponsor
|
| Name |
Pacific dental college and hospital |
| Address |
Pacific dental college and hospital
Debari
Udaipur |
| 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 NIDHI SINHA |
PACIFIC DENTAL COLEGE AND HOSPITAL |
Department of conservative dentistry and endodontics
Pacific dental college and hospital Airport road Debari
Udaipur
RAJASTHAN
313024
India
Udaipur
RAJASTHAN |
08619423478
dr.nidhi.sinha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PACIFIC DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ozonated 2% Chlorhexidine with sodium hypochlorite |
Ozonated 2% Chlorhexidine with sodium hypochlorite applied for 3-5 minutes |
| Comparator Agent |
0.1% Octinidine with sodium hypochlorite |
0.1% Octinidine with sodium hypochlorite applied for 3-5 minutes |
| Comparator Agent |
0.1% Ozonated octinidine with sodium hypochlorite |
0.1% Ozonated octinidine with sodium hypochlorite applied for 3-5 minutes |
| Comparator Agent |
0.1% Ozonated octinidine without sodium hypochlorite |
0.1% Ozonated octinidine without sodium hypochlorite applied for 3-5 minutes |
| Comparator Agent |
2% Ozonated chlorhexidine with sodium hypochlorite |
2% Ozonated chlorhexidine with sodium hypochlorite applied for 3-5 minutes |
| Comparator Agent |
2% Ozonated chlorhexidine without sodium hypochlorite |
2% Ozonated chlorhexidine without sodium hypochlorite applied for 3-5 minutes |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with single rooted, root-filled tooth with persistent apical periodontitis / symptomatic teeth with or without lesion requiring endodontic retreatment with radiographic/clinical evidence of previous endodontic treatment and periradicular disease were included in the study were recruited. Other inclusion criteria were endodontic treatment done > 3 years back, sufficient coronal tooth structure for adequate isolation with rubber dam, gutta-percha material within 4–7 mm of the radiographic apex and no direct exposure of root canal filling material to oral cavity. |
|
| ExclusionCriteria |
| Details |
Medically compromised patients, patients allergic to the local anesthetic agent/ irrigants/ ozone and patients with recent myocardial infarction, acute alcohol intoxication, active bleeding, uncontrolled hyperthyroidism, thrombocytopenia, glucose 6 phosphatase deficiency (contraindications of ozone therapy) were excluded. Patients under 18 years of age, with swelling and/or acute apical abscess; analgesic/ antibiotic/ corticosteroid / anti-inflammatory taken within the past 7 days before treatment, and multiple teeth (to eliminate the possibility of pain referral), periodontal pocket deeper than 4 mm, intraradicular posts were excluded. |
|
|
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 |
| Pain after secondary endodontic treatment |
At baseline, after 6, 12, 24, 48 hours, and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain after secondary endodontic treatment |
At baseline, after 6, 12, 24, 48 hours, and 7 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/02/2022 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim: To compare the effect of different irrigation regimes on post endodontic pain in patients undergoing single-visit endodontic retreatment, with 2% Chlorhexidine and 0.1% Octinidine with and without ozone and hypochlorite. Materials and Methods: Adult patients requiring retreatment were selected. Following local anesthesia and isolation, access cavities were modified. Standard retreatment protocol was followed and patients were randomly assigned into groups - Group 1 - 2% Chlorhexidine with sodium hypochlorite (CHX) (Control group) Group 2 - 2% Ozonated chlorhexidine without sodium hypochlorite (OCHX). Group 3 - 2% Ozonated chlorhexidine with sodium hypochlorite (OCHXH). Group 4 - 0.1% Octinidine with sodium hypochlorite (OCT). Group 5 - 0.1% Ozonated octinidine without sodium hypochlorite (OOCT). Group 6 - 0.1% Ozonated octinidine with sodium hypochlorite (OOCTH). Each group was irrigated with 15 ml of ozonated/non - ozonated irrigant (CHX/ OCT) for 3-5 minutes with ultrasonic agitation. Obturation and core built-up were completed at the same appointment. The level of discomfort at baseline, after 6, 12, 24, 48 hours, and 7 days were recorded on the Visual Analogue Scale. Pain levels were recorded, tabulated, and subjected to statistical analysis using a two-way analysis of variance followed by post hoc Bonferroni test. |