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ENROLLING BY INVITATION
NCT07640074
NA

Clinical Performance of Novel Coconut Based Restorative Material.

Sponsor: Pakistan Institute of Medical Sciences

View on ClinicalTrials.gov

Summary

A triple-blind, parallel group, randomized trial with an allocation ratio of 1:1. Participants randomly allocated into two groups A and B. In group A, nano-reinforced glass ionomer restoration will be utilized while in group B, glass ionomer restoration without nanoparticles was used. Parameters of clinical performance measured will be: A. Surface structure B. Anatomical shape C. marginal adhesion. Clinical performance of Restorations will be assessed with4-level Ryge's scale at baseline, after 1, 3 and 6 months. The numerical Ryge's scale will be used for comparison of quality of restoration in subsequent control clinical examinations and tracking its changes over time. Parameters will be evaluated on standardized scale 0-3. Restorations that will be rated 0 (very good - ideal condition) and 1 (satisfying - requiring minor corrections) will be considered clinically acceptable. Restorations with rating 2 (need for deferred replacement of the restoration) or 3 (unacceptable - restoration needs to be replaced immediately) will be considered clinically unacceptable.

Official title: Clinical Performance of Novel Coconut Based Restorative Material in the Primary Dentition.

Key Details

Gender

All

Age Range

5 Years - 9 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-06-01

Completion Date

2026-12-01

Last Updated

2026-06-10

Healthy Volunteers

Yes

Interventions

DRUG

Nano-reinforced glass ionomer

Group A (glass ionomer restoration reinforced with coconut derived- titania nanoparticles)

DRUG

glass ionomer without nanoparicles

Group B ( glass ionomer restoration without nanoparticles)

Locations (1)

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, Pakistan