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NCT Number: NCT06690229

Evaluation of Different Cementation Materials Used in Prefabricated Pediatric Zirconia Crowns

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.

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Key information

Conditions

Caries,Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aydin Adnan Menderes University

Aydin, Efeler, 09100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

glass ionomer cement

Drug

A cement used for crown cementation

Other names: Ketac Cem (3M ESPE, USA)

self-adhesive resin cement

Drug

A cement used for crown cementation

Other names: RelyX U200 (3M ESPE, St. Paul, USA)

resin modified glass ionomer cement

Drug

A cement used for crown cementation

Other names: FujiCEM Evolve (GC, Tokyo, Japan)

Primary outcomes

  1. Change in clinical performance.

    Time frame: 1 week, 3 months, 6 months, 12 months

    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.

  2. Change in periodontal health (Plaque)

    Time frame: 1 week, 3 months, 6 months, 12 months

    Periodontal health will be assessed using the Plaque index (PI).

    Each of the four surfaces of a tooth will be assigned an index score from 0 to 3 based on the amount of plaque observed:

    0: No plaque is present.

    • A thin layer of plaque is observed along the gingival margin; this thin layer can be detected with a probe.
    • A moderate layer of plaque is observed along the gingival margin, visible to the eye.
    • A substantial amount of plaque is observed at the gingival margin, with interdental areas visibly filled with plaque.

  3. Wear of opposing natural teeth

    Time frame: 1 week, 3 months, 6 months, 12 months

    The Smith and Knight Tooth Wear Index classification, which is used to grade tooth wear, will be applied.

    The incisal surfaces of all teeth will be examined.

    Score 0:

    (Buccal/Lingual/Occlusal/Incisal): No loss of enamel surface characteristics. (Cervical): No loss of contour.

    Score 1:

    (B/L/O/I): Loss of enamel surface characteristics. (C): Minimal loss of contour.

    Score 2:

    (B/L/O): Loss of enamel exposing dentine for less than one third of surface. (I): Loss of enamel just exposing dentine. (C): Defect less than 1 mm deep.

    Score 3:

    (B/L/O): Loss of enamel exposing dentine for more than one third of surface. (I): Loss of enamel and substantial loss of dentine (C): Defect less than 1-2 mm deep.

    Score 4:

    (B/L/O): Complete enamel loss-pulp exposure- secondary dentin exposure. (I): Pulp exposure or exposure of secondary dentine. (C): Defect more than 2 mm deep-pulp exposure- secondary dentine exposure.

  4. Measuring of parental satisfaction

    Time frame: 1 week, 3 months, 6 months, 12 months

    Parental satisfaction will be evaluated on a five-point Likert scale, which responders specify their level of satisfaction.

    • Very dissatisfied
    • Dissatisfied
    • Undecided
    • Satisfied
    • Very satisfied

  5. Change in periodontal health (Gingiva)

    Time frame: 1 week, 3 months, 6 months, 12 months

    Periodontal health will be assessed using the Gingival index (GI).

    The degree of inflammation and bleeding at each of the four surfaces of a tooth will be assessed using the following index system:

    0: No visible signs of inflammation.

    • Mild inflammation with slight color change and edema; no bleeding.
    • Visible, moderate inflammation with a tendency to bleed when a periodontal probe is gently passed along the soft tissue wall of the gingival sulcus.
    • Severe inflammation with marked redness, edema, and spontaneous bleeding.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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