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Clinical Trials/CTRI/2024/08/072626
CTRI/2024/08/072626
Not yet recruiting
Not Applicable

In vivo – evaluation of a novel bioactive restorative resin in proximal restorations of primary molars- A comparative study

KHADER SHERIFF1 site in 1 country258 target enrollmentStarted: August 28, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
KHADER SHERIFF
Enrollment
258
Locations
1
Primary Endpoint
To check the different restoration used in proximal areas of primary tooth

Overview

Brief Summary

Restorative therapy is a part of comprehensive dental care for management ofdental caries that depends on several factors such as caries-risk assessment,

longevity and durability of the dental materials, type of restoration necessitated,

patients’ cooperation towards treatment, and development status of the

primary/permanent dentition, anticipated compliances, and other environmental

influences.

Conventional restorative procedures of extensively damaged or destroyed

carious teeth is a challenging task as removal of the tooth was the principal

mode of treatment for the primary tooth particularly at the anterior region in the

past followed by replacement with an artificial prosthetic substitute until the

eruption of permanent tooth. This may result in psychological impact on the

child by affecting the confidence and normal personality development apart

from esthetical compromise, abnormal habits and speech difficulties.

Restorative materials used in pediatric dentistry should possess specific characteristics such as biocompatibility, durability, aesthetics, and ease of use, to ensure successful outcomes. This study aims to explore a new restorative material that meets these requirements and can potentially enhance the quality of pediatric dental care.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Investigator Blinded

Eligibility Criteria

Ages
4.00 Year(s) to 9.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Apparently healthy and cooperative.
  • Children in the age range of 4 to 9 years.
  • Children with clinically detectable proximal carious lesions.
  • (ICDAS II Scores 3,4,5).

Exclusion Criteria

  • Primary teeth with deep carious lesions / pain Children who are on iron supplements or any other medication that can cause discolouration of the teeth & restoration.
  • Children with special health care needs / uncooperative children / lack of compliance.
  • Children with the evidence of parafunctional habits.

Outcomes

Primary Outcomes

To check the different restoration used in proximal areas of primary tooth

Time Frame: 3 months interval

Secondary Outcomes

  • To check the different restoration used in proximal areas of primary tooth(3 month period)

Investigators

Sponsor
KHADER SHERIFF
Sponsor Class
Private hospital/clinic
Responsible Party
Principal Investigator
Principal Investigator

Dr ARUN E

Madha Dental College

Study Sites (1)

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