Periodontal Biocompatibility of Pediatric Crowns
Comparative Evaluation of Periodontal Biocompatibility of Pediatric Crowns Using Clinical Parameters and GCF Biomarkers
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Rize、土耳其(türkiye)
- Sema Aydinoglu
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Children who were aged between 6 and 9 years
- Children had a score of 3 or 4 on the Frankl Behavioral Scale
- Children had an indication for full coronal restoration in the primary second molars in all the three quadrants
- Presence of extensive or chronic carious lesions involving the pulp with radiographic scores ranging between 2 and 3
- Presence of localized hypoplastic defects
- Normal or non-resorbed interproximal bone levels, defined radiographically as a distance of no more than 2 mm between the interdental bone crest and the cementoenamel junction
- Those where the root resorption level was blunt or the apex was rounded, and those where 1/4 of the root has been resorbed
Exclusion Criteria:
- Children had any systemic disease
- History of allergy to local anesthetic agents, nickel, or resin-based restorative materials
- Extremely poor oral hygiene
- Periodontal disease
- Malocclusion
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Group 1
Teeth diagnosed with an indication for full coronal restoration and treated with stainless steel crown.
|
Clinical periodontal assessments were carried out for all participants at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) follow-up visits. The clinical periodontal status was assessed with the probing pocket depth (PPD), bleeding on probing (BOP), plaque index (PI), and gingival index (GI). For each patient, GCF measurements and sample collection were performed at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) visits. MMP-8 and IL-1β analyses were performed on GCF samples by the enzyme-linked immunosorbent assay (ELISA). |
|
Group 2
Teeth diagnosed with an indication for full coronal restoration and treated with prefabricated zirconia crown.
|
Clinical periodontal assessments were carried out for all participants at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) follow-up visits. The clinical periodontal status was assessed with the probing pocket depth (PPD), bleeding on probing (BOP), plaque index (PI), and gingival index (GI). For each patient, GCF measurements and sample collection were performed at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) visits. MMP-8 and IL-1β analyses were performed on GCF samples by the enzyme-linked immunosorbent assay (ELISA). |
|
Group 3
Teeth diagnosed with an indication for full coronal restoration and treated with fiber glass crown.
|
Clinical periodontal assessments were carried out for all participants at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) follow-up visits. The clinical periodontal status was assessed with the probing pocket depth (PPD), bleeding on probing (BOP), plaque index (PI), and gingival index (GI). For each patient, GCF measurements and sample collection were performed at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) visits. MMP-8 and IL-1β analyses were performed on GCF samples by the enzyme-linked immunosorbent assay (ELISA). |
|
Group 4
Healthy primary molars (control group)
|
Clinical periodontal assessments were carried out for all participants at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) follow-up visits. The clinical periodontal status was assessed with the probing pocket depth (PPD), bleeding on probing (BOP), plaque index (PI), and gingival index (GI). For each patient, GCF measurements and sample collection were performed at baseline (T0), as well as during the third-month (T1) and sixth-month (T2) visits. MMP-8 and IL-1β analyses were performed on GCF samples by the enzyme-linked immunosorbent assay (ELISA). |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
assessment of probing pocket depth (PPD)
大体时间:From beginning to the end of treatment at 6 months
|
probing pocket depth (PPD) was measured the distance between the gingival margin and the deepest point of the sulcus.
PPD was evaluated from six surfaces (mesiobuccal, midbuccal, distobuccal, mesiolingual/mesiopalatal, midlingual/midpalatal, and distolingual/distopalatal) of the teeth.
The measurements were done utilizing a Williams periodontal probe.
|
From beginning to the end of treatment at 6 months
|
|
assessment of matrix metalloproteinase-8 (MMP-8) level in gingival crevicular fluid (GCF)
大体时间:in the sixth month (after sample collection was complete)
|
MMP-8 was performed on GCF samples by the enzyme-linked immunosorbent assay (ELISA) in the Medical Biochemistry Research and Application Laboratory of the Recep Tayyip Erdogan University Faculty of Medicine.
Twenty-four hours before the assay procedure, the eppendorf tubes were removed from the deep freezer and allowed to thaw progressively at -20 °C followed by +4 °C.
Prior to analysis, both the samples and assay reagents were equilibrated to room temperature (18-25 °C).
Each GCF specimen was analyzed individually without combining the samples.
The results were expressed in ng/mL (MMP-8).
|
in the sixth month (after sample collection was complete)
|
|
Assessment of bleeding on probing (BOP)
大体时间:From beginning to the end of treatment at 6 months
|
Bleeding on probing (BOP) scores were obtained from four surfaces (mesial, distal, buccal, and palatal/lingual) of the primary second molars.
The measurements were done utilizing a Williams periodontal probe.
|
From beginning to the end of treatment at 6 months
|
|
Assessment of plaque index (PI)
大体时间:From beginning to the end of treatment at 6 months
|
Plaque index (PI) scores were obtained from four surfaces (mesial, distal, buccal, and palatal/lingual) of the primary second molars.
The measurements were done utilizing a Williams periodontal probe.
|
From beginning to the end of treatment at 6 months
|
|
Assessment of Gingival index (GI)
大体时间:From beginning to the end of treatment at 6 months
|
Gingival index (GI) scores were obtained from four surfaces (mesial, distal, buccal, and palatal/lingual) of the primary second molars.
The measurements were done utilizing a Williams periodontal probe.
|
From beginning to the end of treatment at 6 months
|
|
Assessment of interleukin-1 beta (IL-1β) level in gingival crevicular fluid (GCF)
大体时间:in the sixth month (after sample collection was complete)
|
In GCF samples taken from patients, IL-1β level was determined by enzyme-linked immunosorbent assay (ELISA) according to the manufacturer's instructions at the Medical Biochemistry Research and Application Laboratory of Recep Tayyip Erdoğan University Faculty of Medicine.
Twenty-four hours before the assay procedure, the eppendorf tubes were removed from the deep freezer and allowed to thaw progressively at -20 °C followed by +4 °C.
Prior to analysis, both the samples and assay reagents were equilibrated to room temperature (18-25 °C).
Each GCF specimen was analyzed individually without combining the samples.
The results were expressed in pg/mL (IL-1β).
|
in the sixth month (after sample collection was complete)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.