Evaluation of Different Cementation Materials Used in Prefabricated Pediatric Zirconia Crowns

N/AActive Not RecruitingNCT06690229

Aydin Adnan Menderes University36 enrolled

Overview

Today, with increasing aesthetic demands; the need for materials that are both durable and compatible with the appearance of natural teeth is increasing in paediatric dentistry. Prefabricated zirconium crowns have attracted significant interest in recent years because they meet aesthetic expectations and have offer mechanical strength. There are various traditional and contemporary cement options that can be used for cementation of crowns. The aim of this study is to clinically evaluate prefabricated zirconia crowns cemented to the primary maxillary incisors with three different adhesive cements in terms of periodantal health, plaque accumulation, opposing tooth wear, parental satisfaction, color harmony, retention, marginal integrity and contact compatibility, at the 1-week, 3-month, 6-month, 12-month follow-ups.

The sample size was calculated as 30 with the G\*Power analysis program. Considering the case losses, the sample size will be increased by 20% and a total of 36 teeth will be included. In the study, 3 different cements will be applied to each cement group, 12 teeth. In this study, 36 teeth will be included from patients aged 3-4 years who have two or more surface carious lesions on their maxillary incisors. After necessary caries removal and pulpectomy treatment, prefabricated zirconia crowns will be prepared and cemented under general anesthesia, using one of three randomly selected cements. 12 teeth will be cemented with FujiCEM Evolve (GC, Tokyo, Japan) 12 teeth with RelyX U200 (3M ESPE, St. Paul, USA) 12 teeth with Ketac Cem (3M ESPE, USA) Patients will be called for follow-up examinations one week after the completion of all dental treatments and at 3, 6, and 12 months. During these follow-ups, Gingival Index, Plaque Index, Tooth Wear Index, and Ryge (USPHS) Criteria will be evaluated on the teeth, and a parental satisfaction scale will be completed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex: ALLMin age: 3 YearsMax age: 4 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with consenting parents, * Patients with carious lesions on 2 or more faces of maxillary incisors or interface caries * Those whose related teeth have not undergone pulp treatment, * Patients without periodontal-related attachment loss, without tooth loss as a result of periodontal pathology, * Those requiring treatment with general anaesthesia * Score 1 and score 2 on the Frankl behaviour scale * Those without a history of allergy (such as local anaesthesia, medication, resin-based restorative materials), * Not requiring endocarditis prophylaxis, * No hypoplasia and hypomineralisation of teeth, * Patients whose permanent teeth are more than 1 year away from eruption * Patients with vital teeth and no complaints of percussion, palpation tenderness, nocturnal waking pain and no abscess and/or fistula * Teeth with a healthy lamina dura and periapical appearance * Teeth without mobility and pathological gingival pockets * Teeth with physiological root resorption not exceeding the apical 1/3 level, * No more than 2 mm alveolar bone loss in the interproximal region on the radiograph of the tooth, * No pathological internal or external root resorption, * It has a permanent tooth underneath and its position is normal, * Patients with a flush terminal closure relationship will be included in the study. Exclusion Criteria: * Teeth with periapical infection, abscess or mobility, * In cases where the depth of the gingival pocket exceeds 3 mm, * In the presence of pathological mobility, * In the presence of congenital developmental defects (amelogenesis imperfecta, dentinogenesis imperfecta), * In teeth in infraocclusion, * Patients with abnormal bite due to dental or skeletal orthodontic anomalies, * In the presence of pathological internal or external resorption, * In cases where radiographic bone loss of more than 2 mm in the interdental region is observed * Those with active periodontal disease, * Traumatised teeth, * In cases where the overjet is more than 2 mm, * Patients with deep bite * Cases where the opposite tooth is missing, * Patients with systemic diseases (diseases of the cardiovascular system, endocrine system, urinary system, central nervous system, mental disorders, etc.), * Dangerous medical conditions or harmful oral habits, * Children with bruxism or unilateral chewing habits will not be included in the study. Those who wish to withdraw from the study at any stage will be excluded from the study.

Outcomes

Primary Outcomes

Change in clinical performance.

Modified United States Public Health Service (USPHS) criteria will be used to evaluate retention, marginal integrity, secondary caries, color match, and crown fracture. Restorations are evaluated using an alphabetical grading scale. When assessing based on specific criteria: Alpha (A), represents ideal restorations, Bravo (B), denotes restorations that are not ideal but remain within acceptable limits, Charlie (C), refers to restorations that fall outside clinically acceptable boundaries and require replacement, Delta (D) is assigned to restorations that are either currently mobile or causing damage to surrounding tissues.