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Prefabricated CAD/CAM PEEK Crowns For Primary Molars Restoration

2026년 5월 28일 업데이트: Arab International University

Evaluation of Minimally Prepared CAD/CAM Polyetheretherketone (PEEK) Crowns Efficacy in Restoring Primary Molars

This Split-mouth randomized clinical trial aims to evaluate CAD/CAM prefabricated Polyether ether ketone crowns for primary molars restoration after pulpotomy compared to Stainless steel crowns Over follow-up periods of 3, 6, and 12 months, the sample included 60 children aged 5-9 years who had bilateral mandibular second primary molars.

Each child received a pulpotomy treatment followed by the placement of a stainless steel crown on one side and a PEEK crown on the contralateral side, distributed randomly.

Clinical parameters were subsequently evaluated during the three follow-up periods, including the gingival index, plaque index, bleeding on probing index, restoration retention and integrity, marginal adaptation, color stability, and both parental and child satisfaction.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

Interest in the esthetic aspect of pediatric dental treatment has increased among both children and parents, as children's self-perception is strongly influenced by the appearance of their teeth from an early age. Most esthetic restorative options require extensive tooth preparation compared with stainless steel crowns (SSCs). However, only limited studies have investigated conservative esthetic alternatives for primary molars.

This randomized controlled clinical trial aimed to evaluate the clinical effectiveness of CAD-CAM prefabricated esthetic PEEK crowns compared with stainless steel crowns (SSCs) in restoring primary mandibular second molars after pulpotomy. Clinical performance was assessed according to restoration retention and integrity, gingival health, plaque accumulation, bleeding on probing, marginal adaptation, color stability, and child/parent satisfaction over follow-up periods of 3, 6, and 12 months.

The sample was randomly allocated using the website: randomization.com

A total crowns were randomly distributed into four groups (n=20 per group):

(A): Prefabricated CAD/CAM PEEK crowns with 0.2 mm thickness (B): Prefabricated CAD/CAM PEEK crowns with 0.4 mm thickness (C): CAD/CAM fabricated PEEK crowns prepared according to NuSmile recommendations (D): Stainless steel crowns (SSC). The study included healthy, cooperative children aged 5-9 years requiring pulpotomy treatment for mandibular second primary.

Clinical Procedure

Clinical and radiographic examinations are performed to confirm the indication for pulpotomy treatment, followed by completion of the study form. Local anesthesia and rubber dam isolation are carried out, and pulpotomy is performed according to the conventional technique described by Dean (2016). The tooth is then restored with glass ionomer cement.

After cement setting, conservative tooth preparation is performed using diamond burs with 1-2 mm occlusal reduction. For Groups I, II, and IV, proximal reduction is completed with minimal preparation. In Group III, tooth preparation follows NuSmile recommendations, including occlusal reduction, proximal opening, crown reduction, and a 1 mm subgingival finish line.

For Groups I, II, and IV, the appropriate crown size is selected, checked for marginal adaptation and proximal contacts, then cemented using Fuji I glass ionomer cement. Excess cement is removed using a dental explorer and dental floss.

For the CAD/CAM fabricated PEEK group, a silicone impression is taken and scanned digitally. Crowns are designed using Exocad software and fabricated with CAD-CAM technology. After polishing and internal surface conditioning with aluminum oxide particles, the crown is tried in, cemented with Fuji I glass ionomer cement, and excess cement is removed.

Clinical parameters are evaluated immediately after crown cementation for directly measurable baseline variables and during the three follow-up periods (after 3, 6, 12 months), including the gingival index, plaque index, bleeding on probing index, restoration retention and integrity, marginal adaptation, color stability, and both parental and child satisfaction.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 시리아
      • Damascus, 시리아
        • School of Dental Medicine

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

아니

설명

Inclusion Criteria:

  1. Healthy children aged 5-9 years.
  2. Children requiring pulpotomy of mandibular second primary molars.
  3. Cooperative children rated as positive or definitely positive on the Frankl behavior scale.
  4. No acute or chronic abscess at the anesthesia site.

Exclusion Criteria:

  1. Root resorption exceeding the apical third.
  2. Non-restorable teeth.
  3. Presence of swelling, fistula, or acute or chronic pulpitis.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Prefabricated PEEK crowns of 0.2 mm thickness
Minimally prepared teeth restored with prefabricated PEEK crowns of 0.2 mm wall thickness.
절차: Prefabricated CAD/CAM PEEK with 0.2 mm thickness
The pulpotomized molar assigned to experimental group will be received A Polyether ether ketone prefabricated crown with 0.2mm thickness on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group.
실험적: Prefabricated PEEK crowns of 0.4 mm wall thickness
Minimally prepared teeth restored with prefabricated PEEK crowns of 0.4 mm wall thickness.
절차: Prefabricated CAD/CAM PEEK with 0.4 mm thickness
The pulpotomized molar assigned to experimental group will be received A Polyether ether ketone prefabricated crown with 0.4mm thickness on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group.
실험적: CAD/CAM-fabricated PEEK crowns
Teeth receiving comprehensive preparation and restored with CAD/CAM-fabricated PEEK crowns following the NuSmile preparation protocol.
절차: CAD/CAM-fabricated PEEK Crowns
The pulpotomized molar assigned to experimental group will be received A CAD/CAM fabricated Polyether ether ketone crown on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group.
활성 비교기: Stainless steel crowns
Minimally prepared teeth restored with prefabricated stainless steel crowns, as the positive control group.
절차: Satinless steel crowns
The pulpotomized molar assigned to control group will be received a Stainless steel crown as control group on one side of mandibular arch, and the other side will be received one of the arm 1, 2, or 3

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Gingival Index
기간: Baseline, 3 months, 6 months, and 12 months postoperatively

0 = No gingival inflammation.

  1. = Mild inflammation with slight changes in color and texture affecting part of the marginal gingiva or papilla.
  2. = Mild inflammation with changes in color and texture involving the entire marginal gingiva or papilla.
  3. = Moderate gingival inflammation with obvious redness, surface glazing, edema, and/or enlargement of the marginal gingiva or papilla.
  4. = Severe gingival inflammation with marked redness, edema and/or enlargement of the marginal gingiva or papilla, spontaneous bleeding, and ulceration.
Baseline, 3 months, 6 months, and 12 months postoperatively
Plaque Index
기간: Baseline, 3 months, 6 months, and 12 months postoperatively

0 = No plaque accumulation around the gingival margin.

  1. = Slight plaque accumulation detected only by passing a probe.
  2. = Moderate plaque accumulation visible to the naked eye.
  3. = Heavy plaque accumulation on the crown surface, gingiva, and interdental areas.
Baseline, 3 months, 6 months, and 12 months postoperatively
Bleeding on Probing
기간: Baseline, 3 months, 6 months, and 12 months postoperatively

Bleeding on probing is assessed using a Williams periodontal probe inserted into the gingival sulcus around each crowned tooth. Four sites (mesial, distal, buccal, and lingual) are examined, and bleeding is evaluated 10 seconds after probing as follows:

(-) No bleeding. (+) Bleeding present.
Baseline, 3 months, 6 months, and 12 months postoperatively
Wong-Baker Faces Scale
기간: Baseline, 3 months, 6 months, 12 months postoperatively

A Wong-Baker Faces Scale consisting of six expressive faces is used, ranging from "no hurts" to "hurts worst," to facilitate the child's selection of the appropriate face. The scale ranges from 0 to 10.

The child is given a questionnaire displaying the faces immediately after crown placement and is asked to choose the face that best represents their feeling at that moment. The child indicates the selected face by pointing to it, and the response is recorded in the study form.
Baseline, 3 months, 6 months, 12 months postoperatively

2차 결과 측정

결과 측정
측정값 설명
기간
Color Stability
기간: 3 months, 6 months, 12 months postoperatively

Color stability is assessed using a shade guide as a reference standard. The crown color is compared with the shade guide at each follow-up visit (3, 6, and 12 months) according to the following criteria:

0 = No color change.

  1. = Slight change from the original color.
  2. = Unacceptable color change.
3 months, 6 months, 12 months postoperatively
Restoration retention and integrity
기간: 3 months, 6 months, 12 months postoperatively

The clinical condition of the crown is evaluated during follow-up visits according to the following criteria:

0 = No visible fracture.

  1. = Minor crown fracture that is repairable.
  2. = Major crown fracture that can still be repaired.
  3. = Crown loss and exclusion from the study sample.
3 months, 6 months, 12 months postoperatively
Marginal Adaptation
기간: 3 months, 6 months, 12 months postoperatively

Marginal adaptation discrepancies were evaluated clinically using a sharp explorer and direct visual examination under dental operating light According to the modified United States Public Health Service (USPHS) criteria; (A): An Alpha grade represented a clinically ideal restoration with excellent marginal adaptation, no detectable gap on exploratory examination.

(B): A Bravo grade indicated a clinically acceptable restoration with a slight marginal discrepancy detectable by an explorer, but without dentin exposure.

(C): A Charlie grade was assigned to restorations that were clinically unacceptable due to a definite marginal gap, with exposed dentin.

(D): A Delta grade denotes the worst clinical condition, characterized by gross marginal failure, loss of retention, or other major defects, for which complete replacement of the restoration is required.
3 months, 6 months, 12 months postoperatively
Patient/Parent Satisfaction
기간: 3 months, 6 months, 12 months postoperatively

The child and one parent are asked about their satisfaction with the crowns regarding esthetics and function, and the responses are recorded in the patient form. Evaluation is performed as follows:

  1. = Completely satisfied with both esthetic and functional outcomes.
  2. = Satisfied with esthetic and functional outcomes with a minor remark.
  3. = Minor criticism without negative clinical effects or esthetic defects.
  4. = Desire for improvement in esthetic and functional aspects.
  5. = Completely dissatisfied.
3 months, 6 months, 12 months postoperatively

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Arab International University

협력자

Damascus University

수사관

  • 수석 연구원: Bushra Munzer Shamma, MSc, DDS., Damascus University
  • 연구 의자: Mohannad Laflouf, PhD, MSc, DDS., Damascus University
  • 연구 책임자: Saleh Al Kurdi, PhD, MSc, DDS., Arab International University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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 4월 2일

기본 완료 (실제)

2025년 12월 10일

연구 완료 (추정된)

2026년 8월 26일

연구 등록 날짜

최초 제출

2026년 5월 22일

QC 기준을 충족하는 최초 제출

2026년 5월 28일

처음 게시됨 (실제)

2026년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 28일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 106/SRC/Sep.23.2024

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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