Apically Positioned Flap vs Rolled Flap for Soft Tissue Management During Implant Second-Stage Surgery
2026년 5월 12일 업데이트: Ohio State University
Peri-Implant Soft Tissue Management During Second-Stage Surgery With Two Different Flap Techniques: A Randomized Controlled Study
Patients are being asked to consider joining a research study that looks at two different ways dentists uncover dental implants during a small gum surgery. To join this study, Patients must have two dental implants that are ready to be uncovered. Both uncovering methods used in this research are normal, safe procedures that dentists already use every day. The purpose of this study is to learn which method helps the gums heal better, stay thicker, and look more natural over time.
If patients decide to participate, the dentist will use one method on one implant and the other method on the second implant so we can compare how each implant heals. The study lasts about one year and includes the uncovering surgery plus scheduled follow-up visits. At these visits, the dentist will gently measure your gums, take pictures, take routine dental X-rays, and use a small camera scanner to check how the gum tissue changes. Patients will also be asked to rate any pain or swelling after surgery.
Patients may have soreness, swelling, or minor bleeding-these are the same risks patients would have during normal implant care. Patients may or may not personally benefit, but the extra monitoring may help us track the healing closely, and patients' participation can help dentists improve care for future patients.
Patients can receive regular implant treatment without joining the study. The goal of this summary is to help you think about the pros and cons and decide what feels right for patients.
연구 개요
연구 유형
중재적
등록 (추정된)
16
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Olivia Bodnar, DDS
- 전화번호: 6142924641
- 이메일: bodnar.61@buckeyemail.osu.edu
연구 연락처 백업
- 이름: Guo-Liang Cheng, DDS, MS
- 전화번호: 6142924641
- 이메일: cheng.712@osu.edu
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:
- Patients between the ages of 18-80.
- Non-smokers or former smokers with at least a 5-year successful cessation history.
- Patients with normal systemic health (ASA-I) or well-controlled/stable systemic conditions (ASA-II), such as diabetes with HbA1c < 7.0%, no recent acute myocardial infarction or cerebrovascular accidents within 6 months, or any contraindication for periodontal or implant surgery.
- Patients who had, or plan to have, 2 non-adjacent implants of the same system placed under a two-stage implant protocol.
- The diameter discrepancy of the 2 target implants must be less than 1 mm.
Exclusion Criteria:
- Current smokers, or smokers who have quit <5 years prior to study entry.
- Pregnant or lactating women
- Patients with substance or alcohol abuse
- Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors
- Other systemic conditions or medication affecting wound healing.
- Poor plaque control with plaque score > 20%
- Active/untreated odontogenic and periodontal infections
- Implants placed, or planned to be placed, with one-stage implant protocol.
- The diameter discrepancy of the 2 target implants is equal to or greater than 1 mm (≥ 1 mm).
- Implants showing signs of early peri-implant bone loss or infection.
- Severe loss of keratinized tissue (> 50%) at the implant site
- Non-English speaking individuals for studies involving informed consent.
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: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Apically Positioned Flap (APF)
During implant second-stage surgery, a crestal incision with vertical releases is used to elevate a flap that is repositioned apically and buccally to increase the width of keratinized tissue around the implant, followed by placement of a healing abutment and suturing.
|
A flap design used during implant second-stage surgery in which a crestal incision with vertical releases is performed, and the flap is repositioned apically and buccally to increase the width of keratinized tissue around the implant.
|
|
실험적: Rolled Flap Technique (RFT)
During implant second-stage surgery, a full-thickness flap is elevated, and a pedicled connective tissue portion is de-epithelialized and rolled toward the buccal aspect to increase peri-implant soft tissue thickness, followed by placement of a healing abutment and suturing.
|
A flap design used during implant second-stage surgery in which a pedicled connective tissue portion of the flap is de-epithelialized and rolled toward the buccal aspect to increase peri-implant soft tissue thickness.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Keratinized Tissue Width
기간: Baseline (second-stage surgery) to 12 months after surgery
|
Keratinized tissue width will be measured clinically in millimeters at the mid-buccal aspect of the implant using a periodontal probe at prespecified follow-up visits.
|
Baseline (second-stage surgery) to 12 months after surgery
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|
Change in Peri-Implant Mucosal Thickness
기간: Baseline (second-stage surgery) to 12 months after surgery
|
Peri-implant mucosal thickness will be assessed by superimposing serial intraoral scan data to quantify changes in buccal soft tissue thickness at implant sites over time.
|
Baseline (second-stage surgery) to 12 months after surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pink Esthetic Score (PES)
기간: 3, 6, and 12 months after second-stage surgery
|
Peri-implant soft tissue esthetics will be evaluated using the Pink Esthetic Score based on standardized clinical photographs, assessing papilla, tissue contour, color, and texture.
|
3, 6, and 12 months after second-stage surgery
|
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Change in Peri-Implant Soft Tissue Volume
기간: Baseline to 3, 6, and 12 months after second-stage surgery
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Three-dimensional soft tissue volume changes will be quantified by superimposing serial intraoral scan data obtained at baseline and follow-up visits.
|
Baseline to 3, 6, and 12 months after second-stage surgery
|
|
Early Wound Healing Index
기간: 1 and 2 weeks after second-stage surgery
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Early wound healing will be assessed using a standardized healing index based on tissue color, bleeding, granulation tissue, and epithelialization.
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1 and 2 weeks after second-stage surgery
|
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Plaque Index (PI)
기간: 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
Oral hygiene status will be assessed using the plaque index based on clinical examination at peri-implant sites.
|
1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
|
Modified Sulcular Bleeding Index (mSBI)
기간: 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
Peri-implant soft tissue inflammation will be assessed using the modified sulcular bleeding index during clinical examination.
|
1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
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Postoperative Pain Score
기간: 1 and 2 weeks after second-stage surgery
|
Participant-reported pain will be measured using a visual analog scale (VAS, 0-100), where higher scores indicate greater pain intensity.
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1 and 2 weeks after second-stage surgery
|
|
Postoperative Swelling Score
기간: 1 and 2 weeks after second-stage surgery
|
Participant-reported swelling will be assessed using a visual analog scale (VAS, 0-100), where higher scores indicate greater perceived swelling.
|
1 and 2 weeks after second-stage surgery
|
|
Change in Peri-Implant Bone Level
기간: Baseline to 12 months after second-stage surgery
|
Peri-implant marginal bone levels will be assessed using standardized periapical radiographs and compared between baseline and follow-up.
|
Baseline to 12 months after second-stage surgery
|
공동 작업자 및 조사자
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 6월 30일
기본 완료 (추정된)
2028년 6월 30일
연구 완료 (추정된)
2028년 6월 30일
연구 등록 날짜
최초 제출
2026년 5월 12일
QC 기준을 충족하는 최초 제출
2026년 5월 12일
처음 게시됨 (실제)
2026년 5월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 12일
마지막으로 확인됨
2026년 5월 1일
추가 정보
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기타 연구 ID 번호
- STUDY20252723
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