| CTRI Number |
CTRI/2022/11/047601 [Registered on: 24/11/2022] Trial Registered Prospectively |
| Last Modified On: |
22/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of bacterial colony count reduction of commercially available apple cider vinegar and liquorice for cleaning of root canals in patients |
|
Scientific Title of Study
|
Comparitive evaluation of antimicrobial efficacy of commercially available apple cider vinegar and liquorice in primary endodontic infections :
AN IN VIVO STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monika Tandan |
| Designation |
Professor |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and Endodontics
Sudha Rustagi College of Dental Sciences & Research
sudha rustagi college of dental sciences and research
Faridabad
HARYANA
121002
India |
| Phone |
|
| Fax |
|
| Email |
drmonikaarora@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Tandan |
| Designation |
Professor |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
Department of conservative Dentistry and Endodontics
Sudha Rustagi College of Dental Sciences and Research
sudha rustagi college of dental sciences and research
Faridabad
HARYANA
121002
India |
| Phone |
|
| Fax |
|
| Email |
drmonikaarora@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Tandan |
| Designation |
Professor |
| Affiliation |
Sudha Rustagi College of Dental Sciences and Research |
| Address |
Department of Conservative Dentistry and ENdodontics
Sudha Rustagi College of Dental Sciences & Research
sudha rustagi college of dental sciences and research
Faridabad
HARYANA
121002
India |
| Phone |
|
| Fax |
|
| Email |
drmonikaarora@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sudha Rustagi College of Dental Sciences and Research Sector 89 Kheri More Faridabad Haryana 121002 |
|
|
Primary Sponsor
|
| Name |
Samrin Aliya |
| Address |
Sudha Rustagi College of Dental Sciences & Research |
| 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 |
| Samrin Aliya |
Sudha Rustagi College of Dental Sciences & Research |
Room No 7, Department of Conservative Dentistry and Endodontics, Sector 89, Kheri More, Faridabad, Haryana 121002
Faridabad
HARYANA |
8743970327
samrinaliya003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients with non-contributory medical history and single rooted permanent teeth with necrotic pulp |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Apple Cider Vinegar |
5ml of 100% apple cider vinegar used as irrigant in the root canal for 1 minute |
| Intervention |
Liquorice |
5ml of 100% liquorice used as irrigant in the root canal for 1 minute |
| Comparator Agent |
Sodium Hypochlorite |
5ml of 2.5% sodium hypochlorite used as irrigant in the root canal for 1 minute |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with non-contributory medical history, permanent teeth with necrotic, infected pulp and without periapical lesion as diagnosed clinically and radiographically, with adequate coronal structure for proper isolation, temporization, and restoration will be included |
|
| ExclusionCriteria |
| Details |
Patients with systemic conditions, pregnant patients, acute periapical abscess, retreatment cases, patients on antibiotic therapy within three months, teeth with calcified canals, presence of intraoral or extraoral sinus, immature apex, internal and external resorption and periodontal pockets >5mm will be excluded. |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy of apple cider vinegar and liquorice with that of sodium hypochlorite against primary endodontic infections by estimating reduction of bacterial counts |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison in reduction of bacterial counts at two stages-before biomechanical preparation(s1) and after biomechanical preparation(s2) of each sample |
45 minutes |
| to evaluate the efficacy of Apple Cider Vinegar and Liquorice in primary endodontic infections |
6 months |
|
|
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)
|
30/11/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After following inclusion and exclusion criteria, patients would be divided among three groups and bacterial counts will be estimated before and after biomechanical preparation of root canals. The obtained colony counts will be compared to check efficacy of Apple Cider Vinegar and Liquorice against primary endodontic infections. |