Periodontal Biocompatibility of Pediatric Crowns
Comparative Evaluation of Periodontal Biocompatibility of Pediatric Crowns Using Clinical Parameters and GCF Biomarkers
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Rize、トルコ（Türkiye）
- Sema Aydinoglu
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
assessment of probing pocket depth (PPD)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。