| CTRI Number |
CTRI/2025/03/082712 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different root canal filling materials in primary teeth |
|
Scientific Title of Study
|
Clinical and radiographic evaluation of calcium hydroxide and iodoform and zinc oxide with neem oil as obturating material in primary teeth An in vivo 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 |
Yashashri Pramod Nehete |
| Designation |
Post graduate student |
| Affiliation |
Surendra Dental College and Research Institute |
| Address |
Department of pediatric and preventive dentistry, room number 06, Surendra Dental College And Research Institute, his highness gardens, powerhouse road, Sriganganagar, Rajasthan
Ganganagar
RAJASTHAN
335001
India |
| Phone |
8999602237 |
| Fax |
|
| Email |
yashashrinehete@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suruchi Juneja Sukhija |
| Designation |
Professor and Hod |
| Affiliation |
Surendra Dental College and Research Institute |
| Address |
Department of pediatric and preventive dentistry, Surendra Dental College And Research Institute, his highness gardens, powerhouse road, Sriganganagar, Rajasthan
Ganganagar
RAJASTHAN
335001
India |
| Phone |
9829365880 |
| Fax |
|
| Email |
drsuruchijuneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yashashri Pramod Nehete |
| Designation |
Post graduate student |
| Affiliation |
Surendra Dental College and Research Institute |
| Address |
Department of paediatric and preventive dentistry, room number 06, Surendra Dental College And Research Institute, his highness gardens, powerhouse road, Sriganganagar, Rajasthan
Ganganagar
RAJASTHAN
335001
India |
| Phone |
8999602237 |
| Fax |
|
| Email |
yashashrinehete@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatric and preventive dentistry, Surendra Dental College And Research Institute, HH gardens, Powerhouse Road, Sriganganagar, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Yashashri pramod Nehete |
| Address |
Department of pediatric and preventive dentistry, Room no. 06, Surendra Dental College And Research Institute, HH gardens, Powerhouse Road, Sriganganagar, Rajasthan 335001 |
| 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 Yashashri Pramod Nehete |
Surendra Dental College And Research Institute |
Department of pediatric and preventive dentistry, room no.06, his highness gardens, powerhouse road, Sriganganagar, Rajasthan
Ganganagar
RAJASTHAN |
8999602237
yashashrinehete@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Surendra Dental College And Research Institute |
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 |
| Comparator Agent |
Calcium hydroxide with Iodoform |
Commonly used material is Calcium hydroxide with Iodoform paste which will be used as comparator for obturation after cleaning and shaping of the root canal |
| Intervention |
zinc oxide with neem oil |
New innovative material i.e zinc oxide and neem oil paste will be used as intervention for obturation after cleaning and shaping of the root canal |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Healthy patients between age group of 4-8 years,
Patients willing to take part in study,
Patients exhibiting Frankl’s behavior rating scale score of 3 and 4 [positive (+) and definitely positive (++)],
At least two-thirds of remaining root length,
Sufficient coronal structure remaining Primary teeth with chronic irreversible pulpitis,
Clinical presence of severe pain with redness besides the infected molar,
Radiolucent areas in furcation or periapical region.
|
|
| ExclusionCriteria |
| Details |
Medically compromised patient,
Any clinical sign of tooth mobility (grade 2 or 3) as per Miller’s criteria,
If the root resorption of teeth is more than 1/3rd
Child with special heath care needs,
Tooth that cannot be restored clinically,
Tooth with pulpal floor perforation,
Presence of frank dentoalveolar abscess or extra‑oral swelling (presence of purulence in the canals).
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The clinical success rate regarding postoperative pain, tenderness on percussion, gingival inflammation, sinus tract, swelling, mobility, antibacterial efficacy and resorption. |
1, 3, 6, 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The radiographic success rate regarding postoperative pain, tenderness on percussion, gingival inflammation, sinus tract, swelling, mobility, antibacterial efficacy and resorption. |
1, 3, 6, 9 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
21/03/2025 |
| 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="2"
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
|
Clinical and radiographic evaluation of calcium hydroxide with iodoform and zinc oxide with neem oil as obturating materials in primary teeth - an in vivo study Obturation materials play important role in the success of endodontic treatment for primary teeth. The most commonly used material for primary root canal fillings is zinc oxide eugenol (ZOE). It has some disadvantages such as irritability, delayed periapical tissue repair and high toxicity and tendency to retain even after deciduous tooth exfoliation which may lead to problems such anterior crossbite, palatal eruption, or ectopic eruption of succedaneous teeth as well as risk of bone and cementum necrosis. The second most commonly utilized root canal filling material is calcium hydroxide with iodoform paste. It has excellent radiopacity and antibacterial properties. However, the presence of iodoform in calcium hydroxide can induce irritation in periapical tissues, potentially causing cemental necrosis and in some cases, a hollow tube effect. Considering the drawbacks of zinc oxide eugenol and calcium hydroxide and iodoform, these materials are not regarded as ideal for root canal fillings. This study aims to explore and develop an optimal obturation material with help of Phyto-dentistry, an emerging field in dentistry which involves the use of medicinal plants and their derivatives for the direct or indirect treatment of diseases. Neem, is well known due to its medicinal properties, including antibacterial, antifungal, antiviral, antioxidant, anti-ulcer, and anti-inflammatory effects. It also possesses immunomodulatory, antihyperglycemic, antimalarial properties. Therefore, a mixture of zinc oxide and neem oil has recently introduced as a potential obturating material. Therefore, this study is to evaluate the clinical and radiographic success rate of zinc oxide with neem oil in comparison to calcium hydroxide - iodoform paste in terms of post-operative pain, tenderness on percussion, swelling, gingival inflammation, mobility, antibacterial efficacy, and resorption over 1, 3, 6, 9 months follow-up. |