Evaluation of Different Cementation Materials Used in Prefabricated Pediatric Zirconia Crowns

NCT06690229 | Active Not Recruiting DMC

• 1 other identifier: 2023/037
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caries,Dental

Keywords

Early childhood caries; Zirconia crown; Cementation

Outcome Measures

Primary Outcomes (5)

• 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.

  1 week, 3 months, 6 months, 12 months

• Change in periodontal health (Plaque)

  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. 1. A thin layer of plaque is observed along the gingival margin; this thin layer can be detected with a probe. 2. A moderate layer of plaque is observed along the gingival margin, visible to the eye. 3. A substantial amount of plaque is observed at the gingival margin, with interdental areas visibly filled with plaque.

  1 week, 3 months, 6 months, 12 months

• Wear of opposing natural teeth

  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.

  1 week, 3 months, 6 months, 12 months

• Measuring of parental satisfaction

  Parental satisfaction will be evaluated on a five-point Likert scale, which responders specify their level of satisfaction. 1. Very dissatisfied 2. Dissatisfied 3. Undecided 4. Satisfied 5. Very satisfied

  1 week, 3 months, 6 months, 12 months

• Change in periodontal health (Gingiva)

  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. 1. Mild inflammation with slight color change and edema; no bleeding. 2. Visible, moderate inflammation with a tendency to bleed when a periodontal probe is gently passed along the soft tissue wall of the gingival sulcus. 3. Severe inflammation with marked redness, edema, and spontaneous bleeding.

  1 week, 3 months, 6 months, 12 months

Study Arms (3)

glass ionomer cement

EXPERIMENTAL

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

Drug: glass ionomer cement

dual-cure self-adhesive resin cement

EXPERIMENTAL

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.

Drug: self-adhesive resin cement

resin modified glass ionomer cement

EXPERIMENTAL

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.

Drug: resin modified glass ionomer cement

Interventions

glass ionomer cement DRUG

A cement used for crown cementation

Also known as: Ketac Cem (3M ESPE, USA)

glass ionomer cement

self-adhesive resin cement DRUG

A cement used for crown cementation

Also known as: RelyX U200 (3M ESPE, St. Paul, USA)

dual-cure self-adhesive resin cement

resin modified glass ionomer cement DRUG

A cement used for crown cementation

Also known as: FujiCEM Evolve (GC, Tokyo, Japan)

resin modified glass ionomer cement

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydin Adnan Menderes University

Aydin, Efeler, 09100, Turkey (Türkiye)

Location

Related Publications (8)

• Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.

  PMID: 6935165 BACKGROUND

• Smith BG, Knight JK. An index for measuring the wear of teeth. Br Dent J. 1984 Jun 23;156(12):435-8. doi: 10.1038/sj.bdj.4805394. No abstract available.

  PMID: 6590081 BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• Cohn C. Zirconia-Prefabricated Crowns for Pediatric Patients With Primary Dentition: Technique and Cementation for Esthetic Outcomes. Compend Contin Educ Dent. 2016 Sep;37(8):554-8.

  PMID: 27608199 BACKGROUND

• Srinivasan SR, Mathew MG, Jayaraman J. Comparison of Three Luting Cements for Prefabricated Zirconia Crowns in Primary Molar Teeth: a 36-month Randomized Clinical Trial. Pediatr Dent. 2023 Mar 15;45(2):117-124.

  PMID: 37106541 BACKGROUND

• Alrashdi M, Ardoin J, Liu JA. Zirconia crowns for children: A systematic review. Int J Paediatr Dent. 2022 Jan;32(1):66-81. doi: 10.1111/ipd.12793. Epub 2021 Apr 25.

  PMID: 33772904 BACKGROUND

• Alzanbaqi SD, Alogaiel RM, Alasmari MA, Al Essa AM, Khogeer LN, Alanazi BS, Hawsah ES, Shaikh AM, Ibrahim MS. Zirconia Crowns for Primary Teeth: A Systematic Review and Meta-Analyses. Int J Environ Res Public Health. 2022 Feb 28;19(5):2838. doi: 10.3390/ijerph19052838.

  PMID: 35270531 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Glass Ionomer Cements; Ketac-cem; RelyX U200

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Kadriye Görkem Ulu Güzel, Assoc. Prof.

  gorkemulu@yahoo.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 15, 2024
• Study Start: June 5, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)