| CTRI Number |
CTRI/2025/03/082876 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This is a study comparing the quality of obturation between endoflas and a novel obturating material in primary mandibular molars |
|
Scientific Title of Study
|
Comparative Evaluation of The Quality of
Obturation In Primary Molars Using A Novel Obturating Material Versus Endoflas In Primary Mandibular Molars |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhuvaneswari N |
| Designation |
Postgraduate student |
| Affiliation |
saveetha dental college |
| Address |
No.162,Saveetha dental college and hospital,poonamallee high road,
vellapanchavadi.
Chennai
TAMIL NADU
600077
India |
| Phone |
8220069215 |
| Fax |
|
| Email |
152311004.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G Lavanya |
| Designation |
Reader |
| Affiliation |
Saveetha dental college and hospital |
| Address |
NO.162,Saveetha dental college and hospital,
poonamallee high road,
vellapanchavadi.
Chennai
TAMIL NADU
600077
India |
| Phone |
9047605630 |
| Fax |
|
| Email |
glaavuu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G Lavanya |
| Designation |
Reader |
| Affiliation |
Saveetha dental college and hospital |
| Address |
NO.162,Saveetha dental college and hospital,
poonamallee high road,
vellapanchavadi.
Chennai
TAMIL NADU
600077
India |
| Phone |
9047605630 |
| Fax |
|
| Email |
glaavuu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospital
NO.162,Poonamallee high road,
vellapanchavadi,
Chennai-600077 |
|
|
Primary Sponsor
|
| Name |
BHUVANESWARI N |
| Address |
NO.162,Saveetha dental college and hospital,Poonamallee high road,
vellapanchavadi,
Chennai-600077 |
| 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 G Lavanya |
saveetha dental college and hospitals |
No.162, Saveetha dental college and hospitals ,
poonamallee high road,
vellapanchavadi,
Chennai
TAMIL NADU |
9047605630
glaavu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha dental college and hospitals institutional ethics committee |
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 |
novel obturating material with calcium hydroxide, zinc oxide and metronidazole |
Tooth will be obturated only for once and follow up for 1 month and resorption of the material will be assessed. |
| Comparator Agent |
obturating material- Endoflas |
Tooth will be obturated only for once and follow up for 1 month and resorption of the material will be assessed. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Primary mandibular molars with clinical parameters that includes spontaneous pain, a chronic apical abscess, abnormal mobility unrelated to physiological exfoliation, tenderness on percussion, the presence of a fistula or abscess, and a deep carious lesion with pulp exposure where haemostasis could not be achieved after coronal pulp extirpation. Radiographic evaluation of a lesion with evident pulp exposure within the crown or a deep carious lesion, furcation radiolucency, discontinuation and widening of lamina dura were included in the study. |
|
| ExclusionCriteria |
| Details |
The primary mandibular molar that showed radiographic evidence of root canal obliteration, internal resorption, and physiological root resorption exceeding one-third of the total root length were excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| quality of obturation |
baseline ,1st month ,3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of obturation clinical and radiographic success |
baseline ,1st month ,3rd month |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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 2 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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)
|
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
|
In this split mouth,randomized clinical trial, we aimed to assess the quality of obturation using endoflas versus novel obturating material in primary mandibular molars.The study will assess the clinical success and radiographic success of the both obturating material at the baseline,1st month,3rd month and 6th month.The result of this trial will provide insights in to the impact of the obturating materials in root resorption, Periapical or furcation radiolucency. This will also help paediatric dentists in aiming for a newer formulation of obturating material with increased benefits and overcoming the limitations of the current obturating materials. |