Evaluation of Clinical Success and Parental Satisfaction of Prefabricated Stainless Steel Crowns and Zirconia Crowns Applied to Primary Molar Teeth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Change in periodontal health (Gingiva)
Study Overview
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 4 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in periodontal health (Gingiva)
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) 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)
Change in periodontal health (Plaque)
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. 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.
Wear of opposing natural teeth
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.
Change in clinical performance
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.
Change in periodontal health (Gingiva)
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) 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)
Change in periodontal health (Plaque)
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. 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.
Wear of opposing natural teeth
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.
Change in clinical performance
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.
Secondary Outcomes
- Measuring of parental satisfaction(1 months, 3 months, 6 months, 12 months)
Investigators
Kadriye Görkem Ulu Güzel
Associate Professor
Aydin Adnan Menderes University