Peri-Implant Soft Tissue Augmentation Using a Free Connective Tissue Graft With an Epithelial Collar
2026년 5월 29일 업데이트: I.M. Sechenov First Moscow State Medical University
Application of a Free Connective Tissue Graft With an Epithelial Collar for Peri-Implant Soft Tissue Augmentation in Patients With Soft Tissue Deficiency Around Dental Implants
A prospective randomized interventional clinical trial (RCT) with a parallel-group design is planned.
The study sample will include 32 patients randomly allocated into two groups according to the surgical intervention performed.
In the first group, a free connective tissue graft with an epithelial collar will be used.
In the second group, a free connective tissue graft without an epithelial collar will be used.
In the postoperative period, assessment of changes in the width of keratinized mucosa, soft tissue thickness, pain severity, postoperative swelling, and patient quality of life will be performed.
연구 개요
상태
모집하지 않고 적극적으로
정황
상세 설명
The aim of this study is to perform a comparative analysis of the effectiveness of free connective tissue grafts with and without an epithelial collar for peri-implant soft tissue augmentation. Examination and treatment of patients will be carried out at the Department of Oral Surgery of the E.V. Borovsky Institute of Dentistry, Sechenov University.
The study population will include patients with bounded or distal edentulous defects of the upper or lower jaw combined with soft tissue thickness deficiency around dental implants (<2 mm), requiring peri-implant soft tissue augmentation using a free connective tissue graft.
All patients will be randomly allocated into two groups according to the surgical intervention method. In the first group (n=16), a free connective tissue graft without an epithelial collar will be used, while in the second group (n=16), a free connective tissue graft with an epithelial collar will be used. The groups will be comparable in terms of age and sex characteristics.
Patient randomization will be performed intraoperatively as follows: after dental implant placement and preparation of the recipient site, an envelope containing the randomly assigned treatment method will be opened. Patients in both groups will undergo dental implant placement according to the standard surgical protocol combined with peri-implant soft tissue augmentation.
A mucosal incision will be performed followed by elevation of a mucoperiosteal flap, preparation of the implant bed, and placement of the dental implant. Subsequently, the recipient site will be prepared and a free connective tissue graft harvested from the maxillary tuberosity or palatal area. Depending on the allocated group, a graft with or without an epithelial collar will be used. The graft will be fixed to the mucoperiosteal flap, followed by tension-free wound closure, while the donor site will be closed primarily.
In the postoperative period, standard antibacterial and anti-inflammatory therapy combined with topical antiseptic agents will be prescribed.
연구 유형
중재적
등록 (실제)
32
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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Moscow, 러시아 제국
- I.M. Sechenov First Moscow State Medical University (Sechenov University)
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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
예
설명
- Written informed consent for participation in the study;
- Age between 18 and 45 years;
- Bounded edentulous defects of the upper or lower jaw involving 1-2 teeth combined with soft tissue thickness deficiency around dental implants (<2 mm);
- Teeth without periodontal pathology, with probing depth not exceeding 3 mm throughout the gingival sulcus;
- Satisfactory level of oral hygiene;
- Absence of systemic diseases in the stage of exacerbation or decompensation.
Non-inclusion criteria:
- Patients who previously underwent connective tissue graft harvesting from the same donor site;
- Patients with impacted third molars in the donor site area;
- Presence of concomitant diseases in the stage of exacerbation or decompensation;
- Patients with malignant neoplasms, as well as patients who underwent radiation therapy or chemotherapy within the previous 5 years;
- Patients with a smoking history of more than 10 years.
Exclusion Criteria:
- Patient refusal to continue participation in the study;
- Pregnant or breastfeeding women;
- Patients with coagulation disorders (hemophilia, von Willebrand disease, or anticoagulant therapy);
- Patients with diseases affecting soft tissue healing processes (insulin-dependent diabetes mellitus).
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: first group
Patients will receive a free connective tissue graft without an epithelial collar
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실험적: second group
Patients will receive a free connective tissue graft with epithelial collar
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in the Width of Keratinized Mucosa
기간: Day 90 compared to the 0th day (initial value)
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Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by digital scanning before surgery and on postoperative day 90.
Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.
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Day 90 compared to the 0th day (initial value)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in the Width of Keratinized Mucosa
기간: Day 180 compared to the 0th day (initial value)
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Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by laboratory scanning before surgery and on postoperative day 180.
Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.
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Day 180 compared to the 0th day (initial value)
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Assessment of Scar Formation According to the Modified Scar Index (MSI)
기간: Day 90 compared to the 0th day (initial value)
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Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation.
Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes.
The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation.
Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary.
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Day 90 compared to the 0th day (initial value)
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Assessment of Scar Formation According to the Modified Scar Index (MSI)
기간: Day 180 compared to the 0th day (initial value)
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Assessment of postoperative soft tissue scar quality around dental implants is performed using the Modified Scar Index (MSI) according to Mombelli et al., based on the evaluation of five parameters: scar color, scar contour, soft tissue deformity, scar tissue texture, and wound margin separation.
Each parameter is assessed using a 3-point scale, where: 0 = optimal tissue condition; 1 = moderate scar changes; 2 = pronounced scar changes.
The total MSI score ranges from 0 to 10, with lower scores indicating better clinical outcomes and minimal scar formation.
Clinical assessment is performed visually and by palpation, with additional evaluation using clinical photographs when necessary.
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Day 180 compared to the 0th day (initial value)
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Assessment of Pain Severity
기간: 4 hours compared to the 0th day (initial value)
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Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
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4 hours compared to the 0th day (initial value)
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Assessment of Pain Severity
기간: Day 1 compared to the 0th day (initial value)
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Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
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Day 1 compared to the 0th day (initial value)
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Assessment of Pain Severity
기간: Day 3 compared to the 0th day (initial value)
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Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
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Day 3 compared to the 0th day (initial value)
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Assessment of Pain Severity
기간: Day 5 compared to the 0th day (initial value)
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Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
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Day 5 compared to the 0th day (initial value)
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Assessment of Pain Severity
기간: Day 7 compared to the 0th day (initial value)
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Assessment of pain severity is performed postoperatively using patient questionnaires, where: 0 = no pain; 1-2 = mild pain; 2-3 = moderate pain; 4-5 = moderately severe pain; 6-7 = severe pain; 8-10 = unbearable pain.
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Day 7 compared to the 0th day (initial value)
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Assessment of Postoperative Swelling Severity
기간: Day 1 compared to the 0th day (initial value)
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Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
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Day 1 compared to the 0th day (initial value)
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Assessment of Postoperative Swelling Severity
기간: Day 3 compared to the 0th day (initial value)
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Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
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Day 3 compared to the 0th day (initial value)
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Assessment of Postoperative Swelling Severity
기간: Day 5 compared to the 0th day (initial value)
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Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
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Day 5 compared to the 0th day (initial value)
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Assessment of Postoperative Swelling Severity
기간: Day 7 compared to the 0th day (initial value)
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Assessment of collateral soft tissue swelling compared with adjacent tissues is performed using the following scale: 0 = no swelling; 1 = moderate swelling; 2 = severe swelling.
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Day 7 compared to the 0th day (initial value)
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Assessment of Bleeding
기간: Day 1 compared to the 0th day (initial value)
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Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
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Day 1 compared to the 0th day (initial value)
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Assessment of Bleeding
기간: Day 3 compared to the 0th day (initial value)
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Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
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Day 3 compared to the 0th day (initial value)
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Assessment of Bleeding
기간: Day 5 compared to the 0th day (initial value)
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Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
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Day 5 compared to the 0th day (initial value)
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Assessment of Bleeding
기간: Day 7 compared to the 0th day (initial value)
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Assessment of the presence of a blood taste in the mouth is performed using the following scale: 0 = no blood taste; 1 = intermittent blood taste; 2 = constant blood taste.
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Day 7 compared to the 0th day (initial value)
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Assessment of Analgesic Intake
기간: Day 1 compared to the 0th day (initial value)
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Assessment of the number of Nimesulide 100 mg tablets taken per day.
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Day 1 compared to the 0th day (initial value)
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Assessment of Analgesic Intake
기간: Day 3 compared to the 0th day (initial value)
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Assessment of the number of Nimesulide 100 mg tablets taken per day.
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Day 3 compared to the 0th day (initial value)
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Assessment of Analgesic Intake
기간: Day 5 compared to the 0th day (initial value)
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Assessment of the number of Nimesulide 100 mg tablets taken per day.
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Day 5 compared to the 0th day (initial value)
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Assessment of Analgesic Intake
기간: Day 7 compared to the 0th day (initial value)
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Assessment of the number of Nimesulide 100 mg tablets taken per day.
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Day 7 compared to the 0th day (initial value)
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Quality of Life Assessment According to OHIP-14
기간: Day 0 (initial value)
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Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
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Day 0 (initial value)
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Quality of Life Assessment According to OHIP-14
기간: Day 7 compared to the 0th day (initial value)
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Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
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Day 7 compared to the 0th day (initial value)
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Quality of Life Assessment According to OHIP-14
기간: Day 90-93 compared to the 0th day (initial value)
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Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
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Day 90-93 compared to the 0th day (initial value)
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Quality of Life Assessment According to OHIP-14
기간: Day 180-186 compared to the 0th day (initial value)
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Assessment of patient quality of life is performed using a questionnaire consisting of 10 questions.
The severity of each parameter should be rated from 0 to 4 points, where "0" = absence of the symptom and "4" = symptom is strongly pronounced.
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Day 180-186 compared to the 0th day (initial value)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Igor P Ashurko, I.M. Sechenov First Moscow State Medical University (Sechenov University)
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 6월 20일
기본 완료 (추정된)
2026년 6월 20일
연구 완료 (추정된)
2026년 8월 20일
연구 등록 날짜
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2026년 5월 29일
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처음 게시됨 (실제)
2026년 6월 4일
연구 기록 업데이트
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2026년 6월 4일
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2026년 5월 1일
추가 정보
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