| CTRI Number |
CTRI/2024/06/068819 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To assess the outcome of using calcium hydroxide with and without Zinc oxide nanoparticle root canal medicament as an intervention in diabetic and healthy participants with infected root canals. |
|
Scientific Title of Study
|
Antibacterial efficacy of combined zinc nanoparticles-calcium hydroxide root canal medication in healthy and diabetic patients with apical periodontitis - A case-control 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 |
shaima misbah shafiq |
| Designation |
post graduate student |
| Affiliation |
JSS Dental College And Hospital |
| Address |
JSS Dental College And Hospital, Department Of Conservative
Dentistry And Endodontics, Bannimantap, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
7349350099 |
| Fax |
|
| Email |
shaimarahman1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paras Mull J |
| Designation |
Reader |
| Affiliation |
JSS Dental College And Hospital |
| Address |
JSS Dental College And Hospital, Bannimatap, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9845854977 |
| Fax |
|
| Email |
dr.parasmullj@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paras Mull J |
| Designation |
Reader |
| Affiliation |
JSS Dental College And Hospital |
| Address |
JSS Dental College And Hospital, Bannimatap, Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9845854977 |
| Fax |
|
| Email |
dr.parasmullj@jssuni.edu.in |
|
|
Source of Monetary or Material Support
|
| JSS Dental College And Hospital, Bannimantap, Mysore-570015 |
|
|
Primary Sponsor
|
| Name |
Shaima Misbah Shafiq |
| Address |
JSS Dental College And Hospital, Bannimantap, Mysore-570015 |
| 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 Shaima Misbah Shafiq |
JSS Dental College And Hospital |
JSS Dental College
And Hospital, Room
Number 7, Department
Of Conservative
Dentistry And
Endodontics,
Bannimantap,
Mysore, 570015
Mysore
KARNATAKA |
7349350099
shaimarahman1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
calcium hydroxide |
Two groups of healthy and diabetic patients receive calcium hydroxide intracanal medicament |
| Intervention |
zinc oxide nanoparticles with calcium hydroxide |
Two groups of healthy and diabetic patients receive intracanal medicament of zinc oxide nanoparticles combined with calcium hydroxide |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with controlled type 2 diabetes (HbA1c level is 6.5% or below)having non-vital teeth with apical periodontitis
Radiographic evidence of apical periodontitis (PAI score: 2-5) |
|
| ExclusionCriteria |
| Details |
Systemic factors such as pregnancy, and other co-existing immunocompromised conditions that can impair healing.
Previously endodontically treated teeth
Teeth with gross carious lesions (unrestorable), root fractures, open apex, intraoral and extraoral swelling, and extraoral sinus opening.
Cases showing periodontal pockets deeper than 4 mm.Â
Patients on antibiotic medications within 3 previous months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analyze and quantify the antimicrobial effect of combined ZnO NP-Ca(OH)2 against common endodontic bacteria found in diabetic and healthy patients with pulp necrosis and/or apical periodontitis, by estimating the CFU of canal biofilm. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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 Yet Recruiting |
| 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
|
Population (P)- Diabetic and healthy patients between the ages of 18 and 60 years, with apical periodontitis
Intervention (I)- Placement of prepared intracanal medicament (combined ZnO NP-Ca (OH)2 paste)
Comparator (C)- Placement of standard intracanal medicament (Ca (OH)2 paste)
Outcomes (O)- Reduction in the CFU of endodontic bacteria by addition of ZnO NPs to Ca(OH)2 providing a novel medicament for enhanced root canal disinfection
|