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PBE를 이용한 구치부 간접 레진 복합 수복물의 임상적 평가

2026년 11월 3일 업데이트: Funda Ozturk Bozkurt, Istanbul Medipol University Hospital

Proximal Box Elevation 기법을 사용한 구치부 간접 레진 복합재(Nexco) 수복물의 임상적 성능 및 치주 상태 평가: 최대 3년의 전향적 통제 임상 시험

Evaluation of posterior indirect resin composite restorations with proximal box elevation technique.

Restoration of large posterior defects extending below the cemento-enamel junction (CEJ) with coverage of one or more cusps represent a very common clinical situation. When restoring deep cervical margins biological and technical operative problems may occur. In order to make clinical procedures less fault-prone 'Proximal Box Elevation' (PBE) is an option that refers to application of composite resin in the deepest parts of the proximal areas in order to reposition the cervical margin supragingivally prior to cavity preparation for an indirect restoration.

This project aims to evaluate the clinical performance and periodontal status of posterior indirect composite restorations with PBE. According to study design at least 60 patients will be recruited to project and 80 restorations will be evaluated. The project will be carried out at the School of Dentistry, Istanbul Medipol University,Turkey.

연구 개요

상세 설명

The rehabilitation of decayed or fractured posterior teeth using an indirect technique was introduced for large cavities with coverage of one or more cusps. Problems of biological nature and technical operative may be encountered when restoring large cavities extending below the cement-enamel junction(CEJ).

Biological problems refers to the possible violation of the 'biological width', a recommended distance of 3 mm or more between the restorative margins and the alveolar crest. The technical operative problems include difficulties in tooth preparation, impression making, adhesive cementation of the restoration, finishing and polishing in subgingival areas. In order to eliminate these difficulties Proximal Box Elevation' (PBE) was introduced that proposes application of composite resin in the deepest parts of the proximal areas in order to reposition the cervical margin supragingivally. Whether the PBE technique is the most optimal treatment option for the restoration of cavities extending below CEJ and how the proposed advantages and possible disadvantages could affect the clinical performance of the indirect restorations are the topics extensively discussed among clinicians.

According to results of in vitro studies, PBE was found to be effective in indirect resin composite bonding to deep proximal boxes in terms of marginal quality and adaptation (1).

In a retrospective clinical study, 79 indirect composite restorations were clinically examined following modified United States Public Health Service criteria. Survival rate was 91.1% and success rate was 84.8% after 5 years (2). Similarly, in another clinical study success rate of 71 indirect composite restorations was reported as 100% after 36 months (3). Nevertheless, not much scientific evidence on the influence of PBE technique on the longevity of the restorations and the periodontal health could be found in the currently available literature. Randomized controlled clinical trials with classification of baseline clinical situation and standardization of cavity preparations are necessary to evaluate the clinical performance of this technique.

This study will be carried out as a prospective study, with assessment of the restorations after three years. 80 indirect composite restorations in at least 60 patients will be included. Potential patients attending to Istanbul Medipol University Dental Clinics in Istanbul will be invited to the study. The patients meeting the inclusion criteria will be recruited. After giving their consent to take part in the study, baseline clinical situation will be classified based on technical operative and biological parameters (4).

The treatment procedure is:

Restorative process in all cases, will start with coronal relocation of the margins using flowable composite with maximum thickness 1 to 1.5 mm and followed by resin composite build-up. Defined principles of morphology driven preparation technique will be followed for standardization of cavity preparations. Impression making, fabrication of indirect restoration with SR Nexco and adhesive cementation will be completed according to manufacturer's instructions.

The control procedure is:

The restorations will be evaluated according to marginal adaptation, cavo surface marginal discoloration, approximal contact, fractures and caries associated with restorations. The periodontal status will be assessed with defined periodontal parameters. The controls will be conducted after two weeks, six months, 1year, 2 and 3 years.

연구 유형

중재적

등록 (실제)

80

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

      • Istanbul, 터키 (Türkiye), 34083
        • Istanbul Medipol University, Dental School

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

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Vital or endodontically treated posterior teeth with extensive substance loss
  2. Caries removal or restoration replacement (i.e. amalgam, composite, glass-ionomer)
  3. Large posterior defects with at least one or more cuspal coverage in molars
  4. Proximal defects extending below CEJ and at least one or more cavity margin/margins located beneath the gingival tissues
  5. Maximum 2 indirect restorations with SR Nexco material in each patient
  6. No obvious untreated caries in the rest of the dentition, dental health problems (regularly checked by a dentist)
  7. Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment)
  8. No untreated periodontal disease (only DPSI 1, 2)
  9. Subjects had to be over 18 years of age, be classified according to the American Society of Anesthesiologists (ASA) as ASA I or ASA II, present with moderate to good oral hygiene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility)
  10. Appropriate isolation after cavity preparations
  11. Subjects had to agree to keep the scheduled recall appointments for data collection and maintenance and plan to stay in the area for at least 3 years.

Exclusion Criteria:

  1. Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or 3 2. Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
  2. Poor endodontic prognosis
  3. Pulp exposure
  4. Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago
  5. Extremely hypersensitive tooth
  6. Excluding the teeth, without opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth
  7. Substance loss due to developmental anomalies (hypoplasia, amelogenesis imperfecta etc.)
  8. Subjects who presented severe wear facets and/or reported parafunctional activities such as clenching or nocturnal bruxism
  9. Subjects who are pregnant or breast feeding during the duration of the study
  10. Subjects who are known to be allergic to the ingredients of resin materials

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Indirect restorations with SR Nexco

Large posterior defects with at least one or more cuspal coverage in molars will be restored using the materials listed (SR Nexco). Procedures will be done using local anesthesia. The procedure, starts with removal of caries or defective restorations and coronal relocation of the the margins using flowable composite with maximum thickness 1 to 1.5 mm and followed by resin composite build-up. Defined principles of morphology driven preparation technique will be followed Impression making, fabrication of indirect restoration with SR Nexco and adhesive cementation will be completed according to manufacturer's instructions.

Restoration of tooth with extensive substance loss

다른 이름들:
  • 온레이 및 오버레이 복원

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
FDI (World Dental Federation) criteria for dental restorations assessment
기간: at 3 years

Two independent investigators are responsible for evaluations. The primary outcome will consist in the FDI (World Dental Federation) instruments for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010. This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually. The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.

at 3 years

2차 결과 측정

결과 측정
측정값 설명
기간
Plaque accumulation according to the Silness & Löe (1964) Plaque Index:
기간: at 3 years

The secondary outcome of the study relies on evaluation of periodontal status. Peridontal parameters will be scored between 0 and 3.

0= No plaque in the gingival area.

  1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
  2. Moderate accumulation of soft deposits within the gingival pocket, on the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
  3. Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
at 3 years
Gingival Inflammation according to the Silness & Löe (1964) Gingival Index.
기간: at 3 years

0= Normal gingival.

  1. Mild inflammation-slight change in colour, slight oedema. No bleeding on probing.
  2. Moderate inflammation-redness, oedema and glazing. Bleeding on probing.
  3. Severe inflammation-marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
at 3 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Mutlu Özcan, DDS,PhD, University of Zurich

간행물 및 유용한 링크

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

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)

2018년 9월 11일

기본 완료 (실제)

2022년 9월 14일

연구 완료 (실제)

2025년 5월 3일

연구 등록 날짜

최초 제출

2019년 1월 29일

QC 기준을 충족하는 최초 제출

2019년 2월 5일

처음 게시됨 (실제)

2019년 2월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 10840098-604.01.01-E.34133

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

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