Clinical Performance of Novel Coconut Based Restorative Material.

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Nano-reinforced glass ionomer
  Group A (glass ionomer restoration reinforced with coconut derived- titania nanoparticles)
• Препарат glass ionomer without nanoparicles
  Group B ( glass ionomer restoration without nanoparticles)

Первичные конечные точки

• 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 [Срок оценки: 6 months]

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Shaheed Zulfiqar Ali Bhutto Medical University — Islamabad

Публикации

• 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 PMID 40491641

Идентификаторы

NCT: NCT07640074 · SOD/ERD/2025/100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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