Comparison of Clinical Success of Stainless Steel Crowns and Zirconia Crowns in Primary Molars

NCT06685640 | Recruiting DMC

• 1 other identifier: AADÜDHF 2023/36
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation and understanding of clinical success, parental satisfaction and effects on periodontal tissues are the main expected benefits of prefabricated zirconia crowns and prefabricated stainless steel crowns. For a long time, stainless steel crowns have been the restorative material of choice for children's primary and permanent posterior teeth. Today, prefabricated zirconia crowns are more popular than other options because they meet aesthetic expectations and have high mechanical strength. The aim of this study is to evaluate and compare the periodontal health, plaque accumulation, opposing tooth wear, parental satisfaction, and clinical performance (color match, retention, marginal integrity, marginal discoloration, anatomic form, secondary caries, surface roughness, surface gloss and postoperative sensitivity) of pediatric prefabricated stainless steel and zirconia crowns applied after pulpotomy to asymptomatic, multifaceted, deep carious primary mandibular second molars.

Conditions

Dental Caries; Pulpotomy

Keywords

primary molars; stainless steel crowns; zirconia

Outcome Measures

Primary Outcomes (4)

• Change in periodontal health (Gingiva)

  Gingival evaluation of the patients will be made according to the Loe and Silness Gingival Index. According to this index system: 0 : Normal (absence of inflammation) 1. : Mild gingivitis (slight change in color, slight edema; no bleeding on probing) 2. : Moderate gingivitis (redness, edema, and glazing; bleeding on probing) 3. : Severe gingivitis (marked redness and edema; ulceration; tendency to spontaneous bleeding)

  baseline, 1 months, 3 months, 6 months, 12 months

• Change in periodontal health (Plaque)

  Plaque evaluation of the patients will be performed according to Silness and Loe Plaque Index. After the teeth isolated with cotton before the evaluation are air dried, the amount of plaque in the area near the gingival margin of each tooth will be examined by inspection and examination probe. According to this index system:: 0: No plaque. 1. A thin layer of plaque is visible along the gingival margin. This thin layer can be detected with the examination probe. 2. A moderate layer of plaque is visible along the gingival margin. This plaque can be visually detected. 3. Heavy plaque accumulation is detected at the gingival margin and in the interdental area.

  baseline, 1 months, 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 Smith and Knight Tooth Wear Index criteria are as follows: 0 Points (Buccal/lingual/occlusal/incisal): No loss of enamel surface characteristics (Cervical): No contour loss. Score 1 (Buccal/lingual/occlusal/incisal): Loss of enamel surface features (cervical): Minimal contour loss. Score 2 (Buccal/lingual/occlusal): Dentin opening with enamel loss of less than 1/3 of the surface (incisal): Dentin exposure with enamel loss (cervical): Less than 1 mm defect. Score 3 (Buccal/lingual/occlusal): More than 1/3 of the dentin surface exposed with enamel loss (incisal): Enamel loss and significant dentin loss (cervical): 1-2 mm defect. Score 4 (Buccal/lingual/occlusal): Complete loss of enamel or exposure of pulp/secondary dentin (incisal): Opening of pulp or secondary dentin (cervical): Defect larger than 2 mm or pulp/secondary dentin dehiscence.

  1 months, 3 months, 6 months, 12 months

• Change in clinical performance

  Modified United States Public Health Service (USPHS) criteria will be used to evaluate color match, retention, marginal integrity, marginal discoloration, anatomic form, secondary caries, surface roughness, surface gloss and postoperative sensitivity. Restorations are evaluated and scored alphabetically. When evaluated in terms of any criterion; A: ideal restorations, B: restorations that are not ideal but within acceptable limits, C: restorations that are clinically unacceptable and need to be replaced, D: restorations that are already mobile or damage tissues receive a score of D. During clinical examination and recording, phonetically similar nomenclature is used to avoid misunderstanding of the score in terms of the letter pronounced by the physician: 'A'lfa, 'B'ravo, 'C'harlie, 'D'elta.

  1 months, 3 months, 6 months, 12 months

Secondary Outcomes (1)

• Measuring of parental satisfaction

  1 months, 3 months, 6 months, 12 months

Study Arms (2)

prefabricated stainless steel crowns (Group A)

EXPERIMENTAL

Groups that received prefabricated stainless steel crowns

Other: prefabricated stainless steel crowns

Prefabricated zirconia crowns (Group B)

EXPERIMENTAL

Groups that received prefabricated zirconia crowns

Other: prefabricated zirconia crowns

Interventions

prefabricated stainless steel crowns OTHER

Full coverage restoration after pulpal treatment in multi-surface deep caries of primary mandibular second molars requiring pulpotomy

prefabricated stainless steel crowns (Group A)

prefabricated zirconia crowns OTHER

Full coverage restoration after pulpal treatment in multi-surface deep caries of primary mandibular second molars requiring pulpotomy

Prefabricated zirconia crowns (Group B)

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age range of children from 4 to 5 years.
• Systemically healthy.
• Children who are positive and extremely positive according to the Frankl behavior scale.
• Asymptomatic primary mandibular second molars with multi-surface deep caries requiring pulpotomy treatment.
• No history of spontaneous pain.
• Primary mandibular second molars where bleeding at the pulpotomy site can be controlled within 3 to 5 minutes.
• Having opposing teeth in occlusal contact.
• Patients without any periodontal-related attachment loss.
• Patients without abscesses or fistulas on primary second molars.
• Children who verbally and in writing agree to participate in the study and are willing to attend regular follow-up appointments will be included.

You may not qualify if:

• Having a systemic disease.
• Periapical infection, abscess, or mobility in primary second molars.
• Those with active periodontal disease.
• Malocclusion or missing opposing tooth.
• Primary second molars with pathological internal or external resorption.
• Physiological root resorption exceeding 1/3 of the root.
• Children with bruxism or unilateral chewing habits will not be included in the study.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University

Aydin, Aydın, 09100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Kadriye Görkem Ulu Güzel, Doç. Prof.

  Adnan Menderes Üniversitesi

  STUDY DIRECTOR

Central Study Contacts

Kadriye Görkem Ulu Güzel, Doç. Prof

CONTACT

505-764-6372; gorkem.ulu@adu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)