| CTRI Number |
CTRI/2025/08/092209 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the effectiveness of herbal materials used for treating decayed tooth in 4-8 years old children : A clinical study |
|
Scientific Title of Study
|
Evaluating the Clinical and Radiographic success rate of Herbal Products Used with Zinc Oxide and Endoflas as an Obturating Material in Primary mandibular molars among 4-8 years children : A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PREETHI R |
| Designation |
POST GRADUATE |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur Kancheepuram TAMIL NADU 603319 India
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9342278442 |
| Fax |
|
| Email |
preethirajkumar22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vasanthakumari A |
| Designation |
Professor and head |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Room no:6, first floor,
Department of Pediatric
and Preventive
dentistry,
Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9443615196 |
| Fax |
|
| Email |
vkpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PREETHI R |
| Designation |
POST GRADUATE |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Room no:6, first floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and Hospital, Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9342278442 |
| Fax |
|
| Email |
preethirajkumar22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dental OPD in Adhiparasakthi Dental College and Hospital and Dental camps Room no:6, first
floor, Department of Pediatric and Preventive dentistry, Adhiparasakthi Dental College and
Hospital, Melamruvathur-603319, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| PREETHI R |
Adhiparasakthi dental college and hospital |
Room no:6, first floor, Department of Pediatric and Preventive
dentistry, Adhiparasakthi Dental College and Hospital,
Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India
Kancheepuram
TAMIL NADU |
9342278442
preethirajkumar22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board- Adhiparasakthi Dental College and Hospita |
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 |
Endoflas |
With commercially available Endoflas a homogenous thin mix (powder to liquid ratio - 2:1) was used to coat the root canal walls using reamers.
Following this, a thick mix of the material was pushed into each root canal with a suitable root canal hand plugger and/or cotton pellets.
|
| Intervention |
zinc oxide + neem extract and
zinc oxide + aloe vera as obturating material in pulpectomy |
ZnO powder (1 gm) with 0.4 mL of neem leaf extract was used for mixing to form a paste-like consistency for obturation.
The fresh pulp of aloe vera is mixed with zinc oxide powder on a glass slab in the mixing ratio of 1:2.after bio mechanical preparation these material will be obturated according to the randomization.
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children with age group between 4 and 8 years.
Primary mandibular molars with the presence of deep carious lesions which are indicated for pulpectomy
Radiographic evidence of deep carious lesion or lesion with radiographic pulp exposure
At least 2/3rd of root length present and having adequate bony coverage, presence, or absence of intra-radicular or periradicular radiolucency not involving permanent tooth bud.
|
|
| ExclusionCriteria |
| Details |
Medically compromised children
Presence of pathologic or physiologic mobility.
Non-restorable primary molars and radiographically obliteration of root canal
Presence of internal and external resorption.
Perforated pulpal floor, root resorption of more than a one-third of its length.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
All cause morbidity at 6 months. Success rate of
pulpectomy at 6 months (defined as absence of
clinical symptoms and radiographic signs of
pathology).
|
Baseline, 1 month, 3 months, 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All cause morbidity at 1, 3 months, 6 months. Incidence of post-operative pain, patient satisfaction using Likert scale. |
Baseline, 1 month, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="1"
Months="6"
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
|
A randomized controlled trial was conducted to evaluate the clinical and radiographic success rate of herbal products used with zinc oxide and Endoflas as obturating materials in primary mandibular molars of children aged 4 to 8 years. The study included 45 children divided into three groups: Group 1 (zinc oxide with neem extract), Group 2 (zinc oxide with aloe vera extract), and Group 3 (Endoflas), with 15 children in each group.
The inclusion criteria were primary mandibular molars with deep carious lesions requiring pulpectomy. For the neem group, mature neem leaves were collected, washed, and macerated with 70 percent ethanol. The extract was filtered, the alcohol removed via water bath, and the extract stored in an airtight container. Zinc oxide powder was mixed with neem extract in a 1 gram to 0.4 milliliter ratio to form a paste.
For the aloe vera group, fully extended aloe leaves were washed to remove aloine, disinfected with isopropyl alcohol, peeled, and the pulp collected. This pulp was mixed with zinc oxide powder in a 1 to 2 ratio.
For the Endoflas group, a homogenous mix was prepared. A thin layer was applied to root canal walls using reamers, followed by a thick mix inserted with a hand plugger or cotton pellet. Outcome assessment using Clinical and Radiographic Outcomes at 6-Month Follow-Up. |