Skip to content

Discolouration of baby teeth and filling material due to Pediatric Medications

A Comparative Analysis of Staining Susceptibility: An In Vitro Study of Primary Teeth and Restorative Materials Exposed to Pediatric Medications - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/104966
Enrollment
165
Registered
2026-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K080- Exfoliation of teeth due to systemic causes

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Sardar Patel Postgraduate Institute of Dental and Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Baseline

Secondary

MeasureTime frame
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 Timepoint: 7th Day

Countries

India

Contacts

Public ContactDr Gunjan Yadav

Sardar Patel Post Graduate Institute of Dental and Medical Sciences

drgunjany@gmail.com9454109142

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026