Clinical Performance of Novel Coconut Based Restorative Material.

NCT07640074 | Enrolling By Invitation DMC

• 1 other identifier: SOD/ERD/2025/100
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carious Lesion; Restoration

Keywords

Glass ionomer cement; Titania nanoparticles; Primary teeth

Outcome Measures

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

  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)

  6 months

Study Arms (2)

Group A (Nano-reinforced glass ionomer)

EXPERIMENTAL

glass ionomer restoration reinforced with coconut derived- titania nanoparticles

Drug: Nano-reinforced glass ionomer

Experimental: Group B (Conventional glass ionomer)

EXPERIMENTAL

glass ionomer restoration without nanoparticles

Drug: glass ionomer without nanoparicles

Interventions

Nano-reinforced glass ionomer DRUG

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

Group A (Nano-reinforced glass ionomer)

glass ionomer without nanoparicles DRUG

Group B ( glass ionomer restoration without nanoparticles)

Experimental: Group B (Conventional glass ionomer)

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, Pakistan

Location

Related Publications (1)

• Padilla-Ocampo CA, Medecigo-Costeira D, Pioquinto-Mendoza JR, Navarrete-Hernandez JJ, Mendoza-Rodriguez M, Marquez-Corona ML, Villalobos-Rodelo JJ, Casanova-Rosado JF, Medina-Solis CE, Maupome G. Short-Term Assessment of Cention N vs. Glass Ionomer Cement (Fuji IX) as a Definitive Restoration in the Primary Dentition of Mexican Children: A Pilot Study. Cureus. 2025 May 9;17(5):e83784. doi: 10.7759/cureus.83784. eCollection 2025 May.

  PMID: 40491641 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

glass ionomer

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Care Provider, Outcomes Assessor) In this triple-blind trial, participants, care provider and outcome assessor were unaware of the study groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)