CTRI Number |
CTRI/2021/03/032107 [Registered on: 18/03/2021] Trial Registered Prospectively |
Last Modified On: |
16/03/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Evaluation of ozone therapy in endodontic treatment of teeth with pulpal diseases |
Scientific Title of Study
|
Evaluation of ozone therapy in endodontic treatment of teeth with necrotic pulp and apical periodontitis: A randomised clinical trial |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Nidhi Sinha |
Designation |
Professor |
Affiliation |
Pacific dental college and hospital |
Address |
Department of conservative dentistry and endodontics
Pacific dental college and hospital
Udaipur Rajasthan Pacific dental college and hospital
Airport road Debari
Udaipur RAJASTHAN 313024 India |
Phone |
8619423478 |
Fax |
|
Email |
dr.nidhi.sinha@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Geeta Asthana |
Designation |
Professor and guide |
Affiliation |
Government dental college and hospital Ahmadabad |
Address |
Department of conservative dentistry and endodontics
Government dental college and hospital
Civil hospital road
Asarwa road Ahmedabad
Gujarat Department of conservative dentistry and endodontics
Government dental college and hospital
Civil hospital road
Asarwa road Ahmedabad
Gujarat Ahmadabad GUJARAT 380016 India |
Phone |
9824440656 |
Fax |
|
Email |
geetasthana@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nidhi Sinha |
Designation |
Professor |
Affiliation |
PACIFIC DENTAL COLLEGE AND HOSPITAL |
Address |
Department of conservative dentistry and endodontics
Pacific dental college and hospital
Udaipur Rajasthan Pacific dental college and hospital
Airport road Debari
Udaipur Udaipur RAJASTHAN 313024 India |
Phone |
8619423478 |
Fax |
|
Email |
dr.nidhi.sinha@gmail.com |
|
Source of Monetary or Material Support
|
Pacific dental college and hospital |
|
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
DEBARI
UDAIPUR Udaipur RAJASTHAN |
8619423478
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: K041||Necrosis of pulp, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Ozone activation in single rooted teeth during endodontic treatment |
Ozone irrigation prepared by Dentozone ozonator by ADC India activated by manual agitation |
Comparator Agent |
Ozone activation in single rooted teeth during endodontic treatment |
Ozone irrigation prepared by Dentozone ozonator by ADC India activated by pro agitator tips system (PATS) |
Comparator Agent |
Ozone activation in single rooted teeth during endodontic treatment |
Ozone irrigation prepared by Dentozone Ozonator by ADC India activated by ultra-sonic agitation |
Intervention |
Use of ozone as irrigant in single rooted teeth during endodontic treatment |
Ozone irrigation prepared by Dentozone ozonator by ADC India used without activation |
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.Patients will be selected at random, irrespective of age, sex, caste, religion, etiology and socioeconomic status .
2.Patients with good general health.
3.Patients readily available for follow up.
4.Patient willing to give consent for the study.
5.Patient’s teeth with necrotic pulps and apical periodontitis.
(Primary/ Secondary endodontic treatment).
6.Presence of sufficient coronal tooth structure for rubber dam isolation.
7.Teeth with sound periodontal apparatus will be included in the study.
|
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ExclusionCriteria |
Details |
1.Patients with any systemic diseases, immune-compromised patients.
2.Patients allergic to ozone, recent myocardial infarction, acute alcohol intoxication, active bleeding, uncontrolled hyperthyroidism, thrombocytopenia, Glucose 6 phosphatase deficiency (Contraindications of ozone therapy).
3.Patients on analgesics or antibiotics five days prior to the clinical procedure.
4.Patients unwilling for follow up visits
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Pain assessment following Ozone irrigation in endodontic treatment of single rooted teeth |
0 hours,6 hours, 12 hours, 24 hours , 48 hours, and 7 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Pain assessment following Ozone irrigation in endodontic treatment of single rooted teeth |
0 hours,6 hours, 12 hours, 24 hours , 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)
|
21/03/2021 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NOT YET PUBLISHED |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.nidhi.sinha@gmail.com].
- For how long will this data be available start date provided 21-03-2021 and end date provided 21-03-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Need for the study:
The success of endodontic
treatment is highly related to the elimination or reduction of
post-endodontic pain, many clinical studies have reported varying degrees of
pain, ranging from 25 to 40%. Postoperative
pains in patient undergoing root canal treatment is an undesirable
complication in dental practice for both patient and dentist. The agent that
triggers these events may have different origins, such as physic, chemical or
microbiological; however, the latter seems to be the main cause of
postoperative pain. The intensity of the inflammatory reaction
can be influenced by several factors such as the degree of existing
pathological changes in the periapical region, presence of certain bacterial
species in the root canal.
Current literature on number of visits for root canal treatment
provides conflicting opinions and recommendations. However, single-visit root
canal treatment has become a common practice and offers several advantages,
including decreased number of operative procedures, less time consuming, more
economical for busy patients and no risk of inter-appointment leakage through
temporary restorations. The disadvantages of single visit procedures are also
obvious as it eliminates some of the controls available in the multiple visit
procedures, such as culturing to check the effectiveness of the biomechanical
preparation. But with meticulously instrumentation and
irrigation in a
single-visit root canal treatment a better disinfection and pain management
can be achieved.
In endodontics, root
canal irrigation is an integral part of preparation, which plays an important
role in disinfection and removal of the debridement. The ideal irrigant
should be strongly antimicrobial, able to dissolve the necrotic tissues, the
remaining organic tissues, and be non-toxic to the periapical tissues if
extruded through the apex. Not only irrigation solution but also the
irrigation technique plays a crucial role in successful endodontic treatment.
Therefore, newer irrigation solutions and techniques have to be tested to achieve
this goal.
One such new generation of the disinfectant
agents is ozone; a powerful oxidizing agent used to eliminate bacteria in
root canals. Recent investigations of aqueous ozone have indicated that it is
a powerful antimicrobial agent against oral pathogens and even resistant
microorganisms too. One of the crucial properties of aqueous ozone is its non
toxicity to oral cells in vitro than all other known antiseptics. However,
the most important disadvantage of aqueous ozone is its unstable
concentration in a long time. Consequently, aqueous ozone should be used as
soon as possible after obtaining the ozone generator.
Irrigant exchange can be further improved in
a number of ways, including pressure alteration, sonics, and ultrasonics. The simplest is manual dynamic agitation technique in which the obturating
gutta-percha cone is pumped up and down in the canal. The literature is scarce on studies that
evaluate whether efficacy of Ozone can be optimized by the use of the
ultrasonic, pro-agitator tip system (PATS) or manual dynamic agitation.
Hence, the present study will aim to
evaluate and compare the post-treatment pain after single-visit endodontics
with three different Ozone application techniques (manual and ultrasonic and
pro agitator tip system (PATS).
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