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Periodontal Biocompatibility of Pediatric Crowns

2026년 5월 20일 업데이트: Sema Aydınoglu, Recep Tayyip Erdogan University Training and Research Hospital

Comparative Evaluation of Periodontal Biocompatibility of Pediatric Crowns Using Clinical Parameters and GCF Biomarkers

Different full-coverage crown materials are widely used in pediatric dentistry for the restoration of primary teeth with extensive substance loss. Since these restorations remain in close contact with gingival tissues for prolonged periods, they may influence periodontal health depending on their surface characteristics, marginal adaptation, and biological properties. The aim of this study was to evaluate the effects of stainless steel crowns (SSC), prefabricated zirconia crowns (PZC), and fiber-glass crowns (FGC) on periodontal health in children using both clinical periodontal parameters and gingival crevicular fluid (GCF) biomarkers, including IL-1β and MMP-8, within a split-mouth study design.

연구 개요

연구 유형

관찰

등록 (실제)

21

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

샘플링 방법

확률 샘플

연구 인구

children who applied for the dental treatment to the Faculty of Dentistry in Rize

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
assessment of probing pocket depth (PPD)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 6월 30일

기본 완료 (실제)

2025년 12월 30일

연구 완료 (실제)

2026년 4월 20일

연구 등록 날짜

최초 제출

2026년 5월 14일

QC 기준을 충족하는 최초 제출

2026년 5월 20일

처음 게시됨 (실제)

2026년 5월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 20일

마지막으로 확인됨

2026년 5월 1일

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