Adnan Menderes University
Aydin, Aydın, 09100, Turkey (Türkiye)
Location status: Recruiting
Location contact
Kadriye Görkem Ulu Güzel
CONTACT
Şerifenur Yetiş
CONTACT
NCT Number: NCT06685640
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.
Interested in participating?
Request Info4 year–5 year
All sexes
Interventional
Not applicable
Aydin, Aydın, 09100, Turkey (Türkiye)
Location status: Recruiting
Kadriye Görkem Ulu Güzel
CONTACT
Şerifenur Yetiş
CONTACT
MATERIALS AND METHODS/RESEARCH TECHNIQUES:
Material:
In the study, two different prefabricated crowns will be applied to the right and left primary mandibular second molars after pulpotomy using a split-mouth design. One will be a prefabricated zirconia crown and the other will be a prefabricated stainless steel crown. The sample size was calculated by G*Power analysis program as 12 teeth, 6 teeth in each group. Since this sample size would reduce the validity and reliability of future statistical tests, it was decided to conduct the study with a total of 20 samples, 10 in each group, taking into account possible data loss and the power of the study. Teeth will be randomly divided into two groups according to crown type.
The study will be terminated when the last visit of the last patient providing the sample is completed and the data is finalized.
Method:
In general, in the evaluation of success:
Plaque Index and Gingival Index in pediatric prefabricated stainless steel and zirconia crowns applied to asymptomatic primary mandibular second molars after pulpotomy will be evaluated at baseline and at the 1-month, 3-month, 6-month, and 12-month follow-ups. Tooth Wear Index, Modified United States Public Health Service (USPHS) Criteria, and parental satisfaction will also be assessed at the 1-month, 3-month, 6-month and 12-month follow-ups. Intraoral photographs will be taken immediately after treatment and at each follow-up appointment.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Full coverage restoration after pulpal treatment in multi-surface deep caries of primary mandibular second molars requiring pulpotomy
Full coverage restoration after pulpal treatment in multi-surface deep caries of primary mandibular second molars requiring pulpotomy
Time frame: baseline, 1 months, 3 months, 6 months, 12 months
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)
Time frame: baseline, 1 months, 3 months, 6 months, 12 months
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.
Time frame: 1 months, 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 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.
Time frame: 1 months, 3 months, 6 months, 12 months
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.
Time frame: 1 months, 3 months, 6 months, 12 months
Parental satisfaction will be evaluated on a five-point Likert scale, which responders specify their level of satisfaction.
Contact information is provided by the study sponsor or research team.
Aydin Adnan Menderes University
Other
Evaluation of Clinical Success and Parental Satisfaction of Prefabricated Stainless Steel Crowns and Zirconia Crowns Applied to Primary Molar Teeth
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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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