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Enrolling by Invitation

NCT Number: NCT07640074

Clinical Performance of Novel Coconut Based Restorative Material.

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.

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Key information

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, Pakistan

About this study

This triple-blind parallel group, randomized clinical trial will be conducted at the department of Operative Dentistry and Endodontics, School of Dentistry from June 1 2026, to November 1, 2026. Participants will be randomly distributed into two groups by Lottery method. A consecutive non-probability sampling technique will be used. Before initiating treatment, participants will be briefed about the intervention. In both groups, Isolate the tooth absolutely or relatively as needed. Excavate carious tissue from interproximal, cervical, or occlusal surfaces (for interproximal restorations, place a celluloid matrix band after cavity preparation). Apply 2.25% sodium hypochlorite (one minute application time). Rinse thoroughly for 10 seconds. Condition the cavity with GIC liquid conditioner. Prepare the material at a 1:1 powder-to-liquid ratio. Bulk-fill the cavity with the mixed GIC. Anatomically contour to restore tooth morphology. Verify and adjust occlusion. In group A, Nano-reinforced glass ionomer restorative material will be placed while in group B, glass ionomer restorative material without nanoparticles will be utilized. Parameters of clinical performance measured will be: A. Surface structure ( colour, smoothness, gloss, discolouration) B. Anatomical shape (restoration of anatomical shape, nodules and shear surface) C. marginal adhesion (presence of a marginal fissure, discolouration, cracks, damage to the edges of the filling, secondary caries). Clinical performance of Restorations will be assessed with4-level Ryge's scale at baseline, after 1, 3 and 6 months for clinical performance. The numerical Ryge's scale allows 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. Results will be analyzed statistically with the Cochran's Q test.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

The exclusion criteria will include teeth with pathology, pulp exposure, uncooperative patients where treatment could not be performed, and patients with inadequate oral hygiene.

Treatment and study plan

Nano-reinforced glass ionomer

Drug

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

glass ionomer without nanoparicles

Drug

Group B ( glass ionomer restoration without nanoparticles)

Primary outcomes

  1. Measure clinical behavior of restorations with the use of a 4-level Ryge's scale having 0-3 standardized scale. Parameters measured will be; 1. Surface structure 2-. Anatomical shape 3. marginal adhesion

    Time frame: 6 months

    Restorations will be assessed with4-level Ryge's scale at baseline, after 1, 3 and 6 months. The numerical Ryge's scale allows 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 were 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) were considered clinically unacceptable.Parameters measured will be:

    A. Surface structure ( colour, smoothness, gloss, discolouration) B. Anatomical shape (restoration of anatomical shape, nodules and shear surface) C. marginal adhesion (presence of a marginal fissure, discolouration, cracks, damage to the edges of the filling, secondary caries)

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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