Clinical trial NCT06690229: Evaluation of Different Cementation Materials Used in Prefabricated Pediatric Zirconia Crowns
Official title: Evaluation of Different Cementation Materials Used in Prefabricated Pediatric Zirconia Crowns
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caries,Dental
Keywords: Early childhood caries
Zirconia crown
Cementation
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in clinical performance.
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Change in periodontal health (Plaque)
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Wear of opposing natural teeth
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Measuring of parental satisfaction
timeFrame: 1 week, 3 months, 6 months, 12 months
measure: Change in periodontal health (Gingiva)
timeFrame: 1 week, 3 months, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydin Adnan Menderes University
state: Efeler
Study officials:
affiliation: gorkemulu@yahoo.com
name: Kadriye Görkem Ulu Güzel, Assoc. Prof.
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.