| CTRI Number |
CTRI/2023/09/057968 [Registered on: 22/09/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The influence of different concentration of sodium hypochlorite on the reading of two different apex locator - A clinical study |
|
Scientific Title of Study
|
A Comparative Evaluation of the Influence of Different Concentrations of Sodium Hypochlorite on the accuracy of two different apex locators. – A Randomized Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geetanjali Jain |
| Designation |
Student |
| Affiliation |
KM DENTAL COLLEGE and HOSPITAL |
| Address |
303 D block Taksh AURA NEAR Land T KNOWLWDGE CITY.
ROOM NO. 8 DEPARTMENT OF CONSERVATIVE DENTISTRY and ENDODONTICS KM Shah dental college and hospital piparia road waghodia gujarat 391760
Vadodara
GUJARAT
390019
India |
| Phone |
7415293089 |
| Fax |
|
| Email |
tarangeetanjali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Singh Rao |
| Designation |
Professor |
| Affiliation |
KM Shah Dental college and hospital |
| Address |
Room NO.8 Department of Conservative Dentistry and Endodontics,
Sumandeep Vidyapeeth, Pipariya Road, Waghodia,
Vadodara:391760
Vadodara
GUJARAT
391760
India |
| Phone |
0 |
| Fax |
|
| Email |
drajayinendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Singh Rao |
| Designation |
Professor |
| Affiliation |
KM Shah Dental college and hospital |
| Address |
KM Shah dental college and hospital piparia road waghodia gujarat 391760
Vadodara
GUJARAT
391760
India |
| Phone |
0 |
| Fax |
|
| Email |
drajayinendo@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| KM SHAH DENTAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Dr Geetanjali Jain |
| Address |
Room NO.8 Department of Conservative Dentistry and Endodontics,
Sumandeep Vidyapeeth, Pipariya Road, Waghodia,
Vadodara:391760 |
| Type of Sponsor |
Other [Dr Geetanjali Jain] |
|
|
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 Geetanjali Jain |
km shah dental college and hospital piparia road waghodiya |
Department of conservative and endodontics room no 8
Vadodara
GUJARAT |
7415293089
tarangeetanjali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sumandeepvidyapeethinstitutionalethicscommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Root ZX mini by J Morita Tokyo Japan and AirPex by Orikam |
) under the influence of 0.9% saline, 3% & 5.25%(cerkamed) Sodium Hypochlorite in single Rooted teeth with symptomatic irreversible pulpitis. |
| Comparator Agent |
sodium hypochlorite |
difference in the Accuracy of Two Apex Locators i.e., Root ZX mini (J Morita Tokyo Japan) & AirPex (Orikam) under the influence of 0.9% saline, 3% & 5.25%(cerkamed) Sodium Hypochlorite in single Rooted teeth with symptomatic irreversible pulpitis. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between age group of 18-60 years (ASA classification 1&2) with maxillary or mandibular single canal, single Rooted teeth diagnosed with Symptomatic Irreversible Pulpitis with normal periapical tissues will be included in the study.
2.Teeth with radiographic findings revealing radiolucency in enamel, dentin involving pulp with no periapical changes will be included.
3.A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients with severe or chronic apical periodontitis will be excluded.
2.Teeth with periapical abscess, granuloma, cyst will be excluded.
3.Medically compromised patients will be excluded.
4.Teeth with open apex will be excluded.
5.Teeth with Root resorption will be excluded.
6.Teeth with complex Root canal anatomy will be excluded.
7.Pregnant and lactating women will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will help us to know which Electronic apex locater is performing better in the presence of different concentration of sodium hypochlorite & help the practitioner to know the merits & demerits of these electronic apex locator |
All samples are taken at baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
07/11/2023 |
| 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="1"
Months="0"
Days="0" |
|
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
|
The study is used to compare the influence of different concentration of sodium hypochlorite which is most commonly used irrigation solution . 2 concentrations are used 5.25% and 3 % which will be filled inside the root canal and electronic apex locators are used to measure the length . The apex locators has 2 sides one is attached to the paitents lip and the other is attached to the file which is inserted into the root canal . after the apex loactor gives its reading , it is rechecked with dental x-ray machine and the readings are noted . if there is any discrepancy it is recorded . |