Comparison of Clinical Success of Stainless Steel Crowns and Zirconia Crowns in Primary Molars
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-5
SponsorAydin Adnan Menderes University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Having a systemic disease.
Periapical infection, abscess, or mobility in primary second molars.
Those with active periodontal disease.
Malocclusion or missing opposing tooth.
Trial design
Design model
Crossover
Treatments tested in this trial
prefabricated stainless steel crowns
Other interventionFull coverage restoration after pulpal treatment in multi-surface deep caries of primary mandibular second molars requiring pulpotomy
prefabricated zirconia crowns
Other interventionFull coverage restoration after pulpal treatment in multi-surface deep caries of primary mandibular second molars requiring pulpotomy
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: prefabricated stainless steel crowns (Group A)Experimental treatment 1 intervention
Group B: Prefabricated zirconia crowns (Group B)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
baseline, 1 months, 3 months, 6 months, 12 months2
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.
Time frame
baseline, 1 months, 3 months, 6 months, 12 months3
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.
Time frame
1 months, 3 months, 6 months, 12 months4
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.
Time frame
1 months, 3 months, 6 months, 12 monthsSecondary outcomes
1
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. neutrally satisfied 4. satisfied 5. very satisfied.
Time frame
1 months, 3 months, 6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov