| CTRI Number |
CTRI/2023/03/050662 [Registered on: 14/03/2023] Trial Registered Prospectively |
| Last Modified On: |
13/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
assessment of cement filling inside the teeth |
|
Scientific Title of Study
|
Radiographic assessment of obturation in primary molars with zincoxide power with nigella sativa and eugenol oil - an invivo 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 C Bhavana |
| Designation |
Post Graduate |
| Affiliation |
AMEs Dental College and hosiptal |
| Address |
department of pedodontics, Room 4, AMEs Dental College
Near Govt Polytechnic college
Bijengera road
Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
9059221708 |
| Fax |
|
| Email |
bhavanachandrabanda73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrutha SP |
| Designation |
Professor |
| Affiliation |
AMEs Dental college and hosiptal |
| Address |
department of pedodontics,
room no 4, AME,s Dental College
Near Govt Polytechnic college
Bijengera road
Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
9483329406 |
| Fax |
|
| Email |
shruthavinit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghavendra havale |
| Designation |
Professor and head |
| Affiliation |
AMEs Dental College and Hosiptal |
| Address |
department of pedodontics,
room no 4, AME,s Dental College
Near Govt Polytechnic college
Bijengera road
Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
9448407300 |
| Fax |
|
| Email |
raghavendrahavale@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| out patients of the department,
department of pedodontics and preventive dentistry room no 4,
AME s dental college and hosiptal
raichur-584103 |
|
|
Primary Sponsor
|
| Name |
Dr C Bhavana |
| Address |
A M Es Dental College and Hospital Bijanegera Road Near
government polytechnic college Raichur |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shrutha SP |
A M Es Dental College and Hospital Bijanegera Road Near
government polytechnic college Raichur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C Bhavana |
Department of Pedodontics and Preventive Dentistry Room NO: 04, A M Es Dental College and Hospital |
Out Patient
Department,
Department of
Pedodontics and
Preventive Dentistry,
Room no. 04, A M Es
Dental College and
Hospital Bijanegera
Road Near government
polytechnic college
Raichur.
Raichur
KARNATAKA
Raichur
KARNATAKA |
9059221708
bhavanachandrabanda73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical committee of AMEs Dental College reg no AME/DC/669/22-23 |
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 |
zinc oxide eugenol cement |
zinc oxide powder and eugenol mixture as filling material in the root canal powder liquid ratio is 1:1 and will be there in root canal till exfoliating of primary teeth |
| Comparator Agent |
zinc oxide with nigella sativa |
zinc oxide powder with nigella sativa oil mixture as root canal filling in primary molars its used in power liquid ratio of 1:1 and will be there in tooth till the exfoliating stage |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age group selected between 3-9 years.
2. Children with good systemic health
3. Children with Frankl’s behaviour rating 3&4.
4. Mandibular primary molars with pulpal pathosis involving the radicular pulp.
5. History of spontaneous pain generally occurring at night time.
6. Presence of Extra oral or Intra oral swelling or sinus tract opening.
7. Primary molars with Grade I mobility due to peri radicular infection.
8. On radiographic examination any periodontal wideing or evidence of minimum bone degeneration. |
|
| ExclusionCriteria |
| Details |
1. Children with special health care needs
2. Primary Mandibular molars which can not be restorable.
3. Tooth exhibiting greater than grade I mobility.
4. Presence of extensive external/internal resorption.
5. Having remaining of root length less than 2/3rd.
6. Pathological bone resorption |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| radiological assessment of obturation according to coll and sardians criteria |
immediately after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical symptoms like pain swelling and sinus formation will be assessed |
1 week from the day of treatment completion |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2023 |
| 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="0"
Months="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Radiographic quality assessment of zinc oxide powder with nigella sativa seed oil and eugenol as an obturating material in primary mandibular molar in children of age between 3-9 years. Pulp pathosis and periapical radiolucency are randomly selected and made into 2 groups. Each group contains 30 samples. Group 1 is zinc oxide and eugenol and Group 2 is zinc oxide with nigella sativa seed oil. Standardized pulpectomy procedure will be performed. The quality of obturating material will be assessed by radiographic method using modified Coll and Sadrian’s criteria |