Clinical Performance of Novel Coconut Based Restorative Material.
Enrolling by invitation · Not applicable
Conditions studied: Carious Lesion, Restoration
In brief
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.
Key facts
- Study ID
- NCT07640074
- Run by
- Pakistan Institute of Medical Sciences
- People needed
- 60
- Starts
- 2026-06-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-10
Who can join
Age: 5 and older, up to 9. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- The inclusion criteria shall consider patients from Pediatric Department of hospital between 5 and 9 years of age having either sex with primary teeth requiring restorations of Class I cavities followed by parent or guardian informed consent.
You may not qualify if…
- The exclusion criteria will include teeth with pathology, pulp exposure, uncooperative patients where treatment could not be performed, and patients with inadequate oral hygiene.
Where it is running
- Shaheed Zulfiqar Ali Bhutto Medical University — Islamabad, Pakistan
Full record on ClinicalTrials.gov
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