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临床试验/NCT07640074
NCT07640074Enrolling By Invitation不适用

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

Pakistan Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Triple (Participant, Care Provider, Outcomes Assessor) In this triple-blind trial, participants, care provider and outcome assessor were unaware of the study groups.

入排标准

年龄范围
5 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Afsheen Mansoor

Associate Professor

Pakistan Institute of Medical Sciences

研究点 (1)

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