| CTRI Number |
CTRI/2025/12/099577 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on chitosan and eggshell powder used as a restorative material in children |
|
Scientific Title of Study
|
Chitosan Based Eggshell Nanocomposite As A Posterior Tooth Restorative Material In Children – A Randomised Control 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 |
Dr Priyadharshini S |
| Designation |
Post Graduate Student |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
6B Paediatric and Preventive Dentistry
Chettinad Dental College and Research Institute
Kelambakkam
Chennai 603103
India
Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9597650230 |
| Fax |
|
| Email |
dhanushpriya525@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Daya Srinivasan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
6B Paediatric and Preventive Dentistry
Chettinad Dental College and Research Institute
Kelambakkam
Chennai 603103
Tamil Nadu
India
Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9884476385 |
| Fax |
|
| Email |
dayaswathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Daya Srinivasan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
6B Paediatric and Preventive Dentistry
Chettinad Dental College and Research Institute
Kelambakkam
Chennai 603103
Tamil Nadu
India
Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9884476385 |
| Fax |
|
| Email |
dayaswathi@gmail.com |
|
|
Source of Monetary or Material Support
|
| 6B Paediatric and Preventive Dentistry
Chettinad Dental College and Research Institute
Kelambakkam
Chennai 603103 |
|
|
Primary Sponsor
|
| Name |
Chettinad Dental College |
| Address |
Chettinad Dental College and Research Institute
Kelambakkam
Chennai 603103 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priyadharshini S |
Chettinad Dental College and Research Institute |
6B Paediatric and preventive dentistry
Chettinad Dental College and Research Institute
Kelambakkam
Chennai 603103
Tamil Nadu
India
Chennai
TAMIL NADU |
9597650230
dhanushpriya525@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Chettinad Dental College and Research Institute (IHEC-CDCRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1- Chitosan based eggshell nanocomposite |
Tooth restored with chitosan based eggshell nanocomposite as base and restored with GIC |
| Comparator Agent |
Group 2 - Dycal |
Tooth restored with Dycal as base and restored with GIC |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children requiring class I restoration on both right and left first permanent mandibular molar teeth with International Caries Detection and Assessment System. (ICDAS-II) score of 3.
2. Children and parents who are willing for the treatment and recall.
|
|
| ExclusionCriteria |
| Details |
1. Children requiring restoration on the first permanent mandibular molar teeth with ICDAS-II score other than 3.
2. Children requiring only one permanent first molar restoration where split mouth design is not possible.
3. Pain, swelling, and fistula associated with the first permanent molar teeth.
4. Children with Special Health care Needs.
5. Children with systemic health problems
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the restorative potential of chitosan based eggshell nanocomposite |
By assessing the marginal staining, retention, marginal adaptation, postoperative sensitivity and secondary caries of both groups |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2025 |
| 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
|
INTRODUCTION The prevalence of dental caries in India is 54.16% and is 57% among children of 3-18 years of age. Restoration of teeth involves removal of caries and placement of a bio-compatible material on the tooth. Eggshell contains natural source of calcium and microelements. Calcium and phosphate present in eggshell helps in demineralisation of carious lesion and remineralisation of incipient enamel lesions. Chitosan derived from crustacean source has antimicrobial, bone regeneration properties which is biocompatible. Chitosan has good bonding strength and effectively improves the durability of dental restorations. In this study, chitosan based eggshell nanocomposite is produced. MATERIALS AND METHOD Sample size calculated is 60. Based on split mouth technique, children requiring restoration on both the left and right first permanent mandibular molar are included in the study. All the children will receive the formulated chitosan-based egg shell nanocomposite material as base followed by GIC on one side and standard commercially available DYCAL followed by GIC as restorations on the other side. The type of restoration material to be placed onto the tooth will be decided by flip of a coin. The restorations will be evaluated by two blinded examiners at baseline (after 24 hours), 1 month, 3 months using the FDI criteria. Statistical analysis will be done to determine the effectiveness of the formulated chitosan-based egg shell nanocomposite material. |