Evaluation of Different Cementation Materials Used in Prefabricated Pediatric Zirconia Crowns

Aydin Adnan Menderes University

Status: Active, not recruiting

Conditions: Caries,Dental

Treatments: Drug: resin modified glass ionomer cement; Drug: self-adhesive resin cement; Drug: glass ionomer cement

Study type: Interventional

Funder types: Other

Identifiers

NCT06690229

2023/037

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 3 to 4 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

glass ionomer cement

Experimental group

Description:

Prefabricated zirconia crowns cemented with glass ionomer cement (Ketac Cem (3M ESPE, USA)) on primary maxillary incisors will be clinically evaluated at 1-week, 3-month, 6-month, and 12-month follow-ups in terms of periodontal health, plaque accumulation, wear of opposing teeth, parental satisfaction, color match, retention, marginal integrity, and contact harmony

Treatment:

Drug: glass ionomer cement

dual-cure self-adhesive resin cement

Experimental group

Description:

Prefabricated zirconia crowns will be cemented with dual-cure self-adhesive resin cement (RelyX U200 (3M ESPE, St. Paul, USA)) on primary maxillary incisors and will be evaluated during follow-up sessions.

Treatment:

Drug: self-adhesive resin cement

resin modified glass ionomer cement

Experimental group

Description:

Prefabricated zirconia crowns will be cemented with resin modified glass ionomer cement (FujiCEM Evolve (GC, Tokyo, Japan)) on primary maxillary incisors and will be evaluated during follow-up sessions.

Treatment:

Drug: resin modified glass ionomer cement