이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Effect of Collagen Membrane on Ridge Preservation

2026년 6월 2일 업데이트: Debora Dias

Effect of Collagen Membrane on Ridge Preservation for Delayed Implant Placement in Sites With Absent Buccal Bone Wall: A Randomized Controlled Trial

This study will evaluate whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves ridge preservation after tooth extraction. Ridge preservation is a procedure used to maintain the shape and volume of the jawbone following tooth removal, which is important for future dental implant placement.

Participants will be randomly assigned to receive either ABCC alone or ABCC combined with a collagen membrane. Healing outcomes will be assessed after approximately 4 months using three-dimensional cone beam computed tomography (CBCT) scans.

The primary outcome is the change in horizontal ridge dimension (width). Secondary outcomes include vertical and contour changes in ridge dimensions, changes in soft tissue contour assessed with digital scans, postoperative healing and complications (such as wound dehiscence, swelling, or infection), and patient-reported outcomes, including pain and satisfaction. In a subset of participants, bone healing will also be evaluated using laboratory and imaging analyses of bone samples obtained at the time of implant placement. The study will additionally assess whether the treatment allows implant placement in the ideal position without the need for further bone grafting.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This study is a clinical trial that evaluates two different approaches to preserve the jawbone after tooth extraction in areas where part of the bone is already missing. Preserving the bone is important to support future dental implants.

Participants will be randomly assigned (like flipping a coin) to receive one of two treatments: a bone graft material alone, or the same bone graft combined with a protective collagen membrane placed over it.

Tooth extraction and follow-up care will be performed in the same manner for all participants. After approximately 4 months of healing, participants will return for dental implant placement.

During the healing period and at the time of implant placement, the research team will evaluate how well the bone and gums have healed. This will include three-dimensional CBCT scans, digital intraoral scans, and clinical measurements. In some participants, a small sample of bone will be collected at the time of implant placement to study bone healing.

The study will compare how effectively each treatment maintains the shape and volume of the jawbone, the quality of soft tissue healing, the risk of complications, patient-reported outcomes (PROs), including comfort and satisfaction, and whether additional procedures are required prior to implant placement.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

  • 이름: Carla Sanchez, MS
  • 전화번호: 4126241179
  • 이메일: cab28@pitt.edu

연구 연락처 백업

연구 장소

  • 미국
    • Pennsylvania
      • Pittsburgh, Pennsylvania, 미국, 15213
        • 모병
        • University of Pittsburgh School of Dental Medicine, Department of Periodontics and Preventive Dentistry
        • 연락하다:
        • 수석 연구원:
          • Debora R Dias, DDS, PhD
        • 연락하다:

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Adults aged 18-80
  • Indicated for extraction of a single-rooted maxillary tooth
  • ≥ 50% buccal bone dehiscence confirmed by CBCT reconstructions
  • Presence of both adjacent teeth
  • No interproximal bone loss
  • ASA I-II health status
  • Ability to comply with required procedures, including attending required number of clinic visits

Exclusion Criteria:

  • Patients diagnosed with periodontitis adjacent to the area to be treated
  • History of allergic reactions to local anesthetics or bone graft material (self-reported);
  • Current heavy smokers (≥ 10 cigarettes/day) or those who quit smoking recently (self-reported; last 6 months);
  • Diagnosis of diabetes mellitus, liver or kidney failure (self-reported);
  • Presence of active infectious diseases of any kind;
  • History of chemotherapy or radiation therapy to the head or neck within the past 5 years (self-reported);
  • Severe hematologic disorders (risk for hemorrhage)(self-reported);
  • Assumption of corticosteroids, IV bisphosphonates or immunosuppressive drugs;
  • Any history of alcohol or drug abuse (self-reported);
  • Pregnancy or plans to become pregnant within 4 months of study enrollment (self-reported);

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: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Control group (bone graft only)
Control group (bone graft only): The socket will be grafted with ABCC alone. The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress polytetrafluoroethylene sutures (PTFE) without attempting primary closure.
절차: Minimally Invasive tooth extraction
Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture. Granulation tissue will be carefully removed without flap elevation.
장치: Alveolar ridge preservation with ABCC
The extraction socket will be grafted with ABCC (SigmaGraft®).
실험적: Test group (bone graft + collagen membrane)
Test group (bone graft + collagen membrane): A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate the resorbable collagen membrane (InterCollagen® Guide, SigmaGraft). The socket will then be grafted with ABCC. The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress PTFE sutures without attempting primary closure.
절차: Minimally Invasive tooth extraction
Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture. Granulation tissue will be carefully removed without flap elevation.
장치: Alveolar ridge preservation with ABCC
The extraction socket will be grafted with ABCC (SigmaGraft®).
장치: Resorbable collagen membrane (InterCollagen® Guide)
A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate a resorbable collagen membrane (InterCollagen® Guide; SigmaGraft®). The membrane will be positioned in the buccal tunnel to replace the missing buccal bone wall and provide graft containment.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Horizontal dimensional changes (%)
기간: Baseline and 4 months
Change in horizontal ridge width at 3 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months

2차 결과 측정

결과 측정
측정값 설명
기간
Horizontal dimensional changes (%)
기간: Baseline and 4 months
Change in horizontal ridge width at 1 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months
Horizontal dimensional changes (%)
기간: Baseline and 4 months
Change in horizontal ridge width at 5 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months
Vertical dimensional changes (%)
기간: Baseline and 4 months
Change in vertical ridge height at the midbuccal aspect, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months
Vertical dimensional changes (%)
기간: Baseline and 4 months
Change in vertical ridge height at the mid palatal aspect, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months
Volumetric dimensional changes (%)
기간: Baseline and 4 months
Change in the volume of the alveolar process (mm3), measured on CBCT scans in comparison to baseline and expressed in percentage change.
Baseline and 4 months
Mid-buccal soft tissue contour change (mm)
기간: Baseline and 4 months
Linear measurement (mm) of mid-buccal soft tissue profile change assessed by superimposition of stereolithography (STL) datasets. Adjacent teeth are used as reference for alignment. A positive value indicates soft tissue gain; a negative value indicates recession.
Baseline and 4 months
Mid-buccal soft tissue volume change (%)
기간: Baseline and 4 months
Volumetric change (mm³) in mid-buccal soft tissue contour calculated by superimposition of STL datasets and expressed in percentage. Color-coded deviation maps will illustrate areas of soft tissue collapse or gain.
Baseline and 4 months
Interproximal papilla height change (mm)
기간: Baseline and 4 months
Linear measurement (mm) of interproximal papilla height change assessed by superimposition of STL datasets in comparison to baseline. A positive value indicates papilla gain; a negative value indicates papilla loss.
Baseline and 4 months
Wound healing (Wound Healing Index)
기간: 1 week, 2 weeks, 1 month, 4 months
Wound healing quality assessed using the Wound Healing Index (WHI), a 3-point ordinal scale where 1 = uneventful healing (complete soft tissue coverage, no complications), 2 = normal healing with minor complications, and 3 = poor healing (dehiscence, exposure, or infection requiring intervention). Lower scores indicate better healing.
1 week, 2 weeks, 1 month, 4 months
Incidence of postoperative complications (Percentage)
기간: 1 week, 2 weeks, 1 month, 4 months
Proportion of participants experiencing at least one postoperative complication (edema, erythema, suppuration, graft exposure, or wound dehiscence) at any follow-up visit. Complications will be recorded by a blinded clinical examiner at each scheduled visit.
1 week, 2 weeks, 1 month, 4 months
Postoperative pain
기간: Day 1, Day 3, 1 week
Numeric scale (0-10) for pain after the extraction and ridge preservation procedure.
Day 1, Day 3, 1 week
Oral health-related quality of life (OHIP-14)
기간: Baseline, 2 weeks, 4 months
Oral health-related quality of life assessed using the Oral Health Impact Profile - 14 (OHIP-14), a validated 14-item questionnaire.
Baseline, 2 weeks, 4 months
Feasibility of prosthetically ideal implant placement without additional augmentation
기간: 4 months
Ability to place the implant in a prosthetically ideal three-dimensional position at reentry without the need for additional hard-tissue augmentation.
4 months
Histological Outcomes
기간: 4 months
In a subset of patients, a bone core biopsy will be obtained. Percent area of new bone, residual graft, and marrow spaces assessed by histomorphometric analysis of bone core biopsies obtained at the time of implant placement.
4 months
Patient satisfaction (VAS)
기간: 4 months
Visual analogue scale (0-100) of patient satisfaction with the appearance of the soft tissues
4 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Debora Dias

협력자

SigmaGraft Inc.

수사관

  • 수석 연구원: Debora R Dias, DDS, PhD, University of Pittsburgh, Department of Periodontics and Preventive Dentistry

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)

2026년 5월 26일

기본 완료 (추정된)

2027년 10월 31일

연구 완료 (추정된)

2027년 10월 31일

연구 등록 날짜

최초 제출

2026년 4월 10일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 2일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • STUDY25080006

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared outside the primary research group due to concerns regarding participant privacy and confidentiality, as approved by the University of Pittsburgh Institutional Review Board.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

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. .

치조골 손실에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Bosnia & Herzegovina

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다