| CTRI Number |
CTRI/2026/02/104966 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
01/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
In vitro |
| Study Design |
Other |
|
Public Title of Study
|
Discolouration of baby teeth and filling material due to Pediatric Medications |
|
Scientific Title of Study
|
A Comparative Analysis of Staining Susceptibility: An In Vitro Study of Primary Teeth and Restorative Materials Exposed to Pediatric Medications |
| 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 Ananya Srivastav |
| Designation |
Post Graduate Student |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Room number 5 Third floor
Department of Pediatric and Preventive Dentistry
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Utrathiya, Lucknow
Chaudhary Vihar
Utrathiya
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
8948943341 |
| Fax |
|
| Email |
ananyasrivastav1810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunjan Yadav |
| Designation |
Professor |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Room number 5 Third floor
Department of Pediatric and Preventive Dentistry
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Utrathiya, Lucknow
Chaudhary Vihar
Utrathiya
Lucknow
UTTAR PRADESH
226029
India |
| Phone |
9454109142 |
| Fax |
|
| Email |
drgunjany@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gunjan Yadav |
| Designation |
Professor |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
Room number 5 Third floor
Department of Pediatric and Preventive Dentistry
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Utrathiya, Lucknow
Chaudhary Vihar
Utrathiya
UTTAR PRADESH
226029
India |
| Phone |
9454109142 |
| Fax |
|
| Email |
drgunjany@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sardar Patel Postgraduate Institute of Dental and Medical Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, Floor number 3, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Chaudhary Vihar,
Utrathiya, Lucknow- 226025 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Ananya Srivastav |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
Department of Pediatric and Preventive Dentistry, Floor number 3, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Chaudhary Vihar, Utrathiya, Lucknow - 226025
Lucknow
UTTAR PRADESH |
8948943341
ananyasrivastav1810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICALCOMMITTEE SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND Register U MEDCIAL SCIENCES LUCKNOW |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K080||Exfoliation of teeth due to systemic causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Non-carious extracted or exfoliated primary teeth (molars or incisors) obtained ethically from patients undergoing planned dental extractions for reasons unrelated to pathology
Teeth free from visible defects, including cracks, chips or previous restorations, to avoid variability in results caused by pre existing conditions.
Properly stored primary teeth in artificial saliva to maintain structural and colour integrity before experimental procedures.
Specimens stored at a controlled temperature (37 degree Celsius) in artificial saliva for polymerization and to simulate oral conditions.
|
|
| ExclusionCriteria |
| Details |
Teeth showing visible decay, fractures or discoloration as these factors may influence baseline colour and final outcomes.
Teeth with preexisting restorations or surface coatings, which could interfere with the experimental procedure.
Specimens exhibiting evidence of erosion, abrasion, or developmental defects such as enamel hypoplasia.
Specimens with air bubbles, incomplete polymerization or surface irregularities that could affect colour stability and measurement accuracy.
Disc specimens damaged during fabrication or storage.
Teeth improperly stored, leading to dehydration or contamination which could compromise the integrity of the enamel surface and baseline measurements.
Teeth exposed to substances or conditions outside the protocol such as accidental exposure to staining agents before experimentation.
Samples deviating significantly from standardized dimensions or preparation protocols, including inconsistent restorative material disc thickness or tooth window sizes.
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcomes:
1. Assessment of the effects of antibiotic, iron supplement, multivitamin and cough syrup on the colour stability of primary teeth.
2. Evaluation of the colour stability of Cention N, a tooth-coloured restorative material, when exposed to antibiotic, iron supplement, multivitamin and cough syrup.
3. Evaluation of the colour stability of LC GIC, a tooth-coloured restorative material, when exposed to antibiotic, iron supplement, multivitamin and cough syrup. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes:
1. Comparison of the degree of discolouration in primary teeth influenced by antibiotic, iron supplement, multivitamin, cough syrup and artificial saliva.
2. Comparison of the degree of discolouration of Cention N influenced by antibiotic, iron supplement, multivitamin cough syrup and artificial saliva.
3. Comparison of the degree of discolouration of LC GIC influenced by antibiotic, iron supplement, multivitamin cough syrup and artificial saliva
|
7th Day |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
11/03/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
1. Background of StudyThe pursuit of optimal aesthetics in Pediatric Dentistry has become increasingly significant, as both children and their parents place a high value on the appearance of dental restorations. [1] A healthy, natural-looking smile not only contributes to a child’s self-esteem and social acceptance but also plays a crucial role in psychological and physiological development. [2,3] The staining of the primary teeth is regarded as a common concern of parents since it can decrease social communications and the self-esteem of the children due to the dark, unaesthetic appearance of the teeth.[4] Consequently, restorative materials used in Pediatric Dentistry must not only restore function but also maintain their aesthetic appearance over time. Commonly used aesthetic restorative materials in Pediatric Dentistry include Composite resins, GICs, and Compomers.[5,6] Recent advancements have introduced materials like Giomers, Alkasites, and Bioactive restoratives, which offer enhanced aesthetic and mechanical properties suitable for both deciduous and permanent teeth.[7,8] These materials aim to fulfil the increasing aesthetic demands while providing functional rehabilitation. However, a persistent challenge remains: the colour stability of these materials over the lifespan of the restoration. Discolouration of restorative materials is influenced by intrinsic factors, such as the resin matrix composition, filler particle size, and degree of polymerization and extrinsic factors, including exposure to dietary substances, medications and oral hygiene practices.[9,10] In pediatric patients, liquid medications, particularly antibiotics, iron supplements, multivitamins and cough syrup, are of notable concern due to their potential to cause discolouration of restorativematerials and teeth.[11,12] Therefore, it is necessary to assess and analyse the discolouration of various restorative materials and primary teeth caused by commonly prescribed pediatric medications. |