Long-Term Bone Dimensional Changes Following Flapless Immediate Implant Placement
2026년 9월 4일 업데이트: International Dental Contiuing Education
Long-Term Bone Dimensional Changes Following Flapless Immediate Implant Placement With or Without Bone Grafting: A 5 Years Follow up of a Randomized Clinical Trial
Nowadays, achieving long-term hard tissue stability is the definitive goal of a successful immediate implant placement and has become the optimal challenge for clinicians over the past few decades.
It is wellestablished that the dimensional changes and remodeling of the alveolar ridge represent a physiologic sequela of tooth extraction and is inevitable especially the labial bone wall.
This creates an unfavorable labio-palatal discrepancy and produces the "fixture-socket gap" around the coronal portion of the implant, known as the labial gap especially in sockets with thin bone.Although this gap has the potential to repair spontaneously in some cases, still previous studies reported that this gap cannot be completely filled without using a regenerative material.
It has been claimed that buccal/labial gap augmentation contributes to the final esthetic success of the dental implant, where the regenerative material acts as a scaffold to maintain the blood clot, promote bone formation, compensate for the postextraction socket remodeling and maintain the buccal bone thickness and thereby preventing the buccal contour collapse.
Nevertheless, this would add an additional cost and prolong the surgical procedure.
Meanwhile, there is a controversy in the existing literature regarding the actual benefit of using bone grafts in the buccal gap.
Previous systematic reviews concluded that there is not sufficient evidence to prove that immediate implant placement with grafting the labial gap, would comprise an additional benefit in preventing alveolar ridge reduction and contour collapse.
Furthermore, previous controlled clinical trials reported that evidence for this additional treatment is still unclear.
연구 개요
상세 설명
Patients who completed the initial trial and received a single immediate implant in a fresh extraction socket would be invited for reassessment at 5 years after implant placement.
The intervention group would comprise patients treated with flapless immediate implant placement combined with grafting of the peri-implant gap using the same bone-substitute material and protocol applied in the original study, while the control group would comprise patients treated with flapless immediate implant placement without bone grafting.
The primary outcome would be the change in peri-implant marginal bone level and three-dimensional alveolar ridge dimensions, assessed by standardized periapical radiographs and, where ethically and clinically justified, limited-field cone-beam computed tomography, compared with baseline and the earlier follow-up measurements.
Secondary outcomes would include implant survival and success, peri-implant probing depth, bleeding on probing, plaque accumulation, mucosal recession, width of keratinized mucosa, facial soft-tissue profile, biological complications, prosthetic complications, patient satisfaction, and esthetic outcomes.
Assessments should be performed by calibrated, blinded examiners using standardized imaging and clinical protocols.
The study would analyze all eligible participants according to their original randomized allocation, report reasons for loss to follow-up, and compare the long-term dimensional stability and clinical performance of grafted versus nongrafted sites.
The principal hypothesis would be that bone grafting may reduce long-term horizontal ridge resorption and improve preservation of the facial contour without adversely affecting implant survival or peri-implant health over the 5-year observation period.
연구 유형
중재적
등록 (추정된)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Cairo, 이집트
- International Dental Continuing Education (IDCE) Research Institute
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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
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Adult (>20 years) with nonrestorable maxillary teeth in the esthetic zone, thick gingival phenotype, intact but thin labial plate of bone extending 7 mm (≤1 mm) and intact palatal bone extending at least 6 mm apically, sufficient apical bone to attain implant primary stability (a minimum of 35 N cm insertion torque) and labio-palatal socket dimension measured from the CBCT axial cut at mid-crestal part ≥5 mm.
Exclusion Criteria:
- Smokers, pregnant women, patients with systemic disease, patients with parafunctional habits such as bruxism or clenching, infected socket, periapical pathosis and history of radiotherapy or chemotherapy within the past 2 years.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: IIP + Bone graft + CHA
For patients assigned to receive a graft, demineralized bovine bone graft (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland) was placed in the gap labial to the implant to the level of the implant platform.
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A tapered screw-vent bone level implant (Zimmer implant TSV, IN, USA) was inserted into the extraction socket in a flapless manner, engaging 3-4 mm of the sound intact apical and palatal bone to achieve primary stability using the motor and manual torque wrench which was set to be at least 35 N cm to allow nonfunctional immediate loading.
The implant platform was located 1.5 mm subcrestal or equicrestal to the labial bone and the implant diameter was selected to leave a labial gap of at least 1.5 mm.
Following implant placement, randomization sequence with allocation to either graft or no graft group was revealed.
For patients assigned to receive a graft, demineralized bovine bone graft (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland) was placed in the gap labial to the implant to the level of the implant platform.
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실험적: IIP + CHA only
A tapered screw-vent bone level implant (Zimmer implant TSV, IN, USA) was inserted into the extraction socket in a flapless manner, engaging mm of the sound intact apical and palatal bone to achieve primary stability using the motor and manual torque wrench which was set to be at least 35 N cm to allow nonfunctional immediate loading.
The implant platform was located 1.5 mm subcrestal or equicrestal to the labial bone and the implant diameter was selected to leave a labial gap of at least 1.5 mm.
Following implant placement, patients received an immediate anatomical customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the shape of the socket at the marginal gingiva (Filtek™ Supreme Ultra Flowable Restorative, 3M Corporate Headquarters, MN, USA).
It was then screwed to the implant
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A tapered screw-vent bone level implant (Zimmer implant TSV, IN, USA) was inserted into the extraction socket in a flapless manner, engaging 3-4 mm of the sound intact apical and palatal bone to achieve primary stability using the motor and manual torque wrench which was set to be at least 35 N cm to allow nonfunctional immediate loading.
The implant platform was located 1.5 mm subcrestal or equicrestal to the labial bone and the implant diameter was selected to leave a labial gap of at least 1.5 mm.
Following implant placement, randomization sequence with allocation to either graft or no graft group was revealed.
For patients assigned to receive no graft an immediate anatomical customized healing abutment fabricated by adding flowable composite to the temporary cylindrical abutment mimicking the mimicking the shape of the socket at the marginal gingiva was screwed to the implant
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Labial bone formed labial to the implant
기간: 5 years follow up
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Measure using the CBCT, the amount of bone formed labial to the implant
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5 years follow up
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여기에서 이 연구와 관련된 사람과 조직을 찾을 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 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2026년 11월 1일
연구 완료 (추정된)
2026년 12월 1일
연구 등록 날짜
최초 제출
2026년 9월 4일
QC 기준을 충족하는 최초 제출
2026년 9월 4일
처음 게시됨 (실제)
2026년 9월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 4일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IDCE-4292026
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
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