- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07576439
Influence of Keratinized Tissue Width and Attached Gingiva Width on Root Coverage in Patients With Recession Defects: A Prospective Clinical Study
To evaluate the association between the width of keratinized tissue and attached gingiva with root coverage outcomes in RT1 gingival recession defects of maxillary and mandibular anterior teeth treated with subepithelial connective tissue graft (CTG) using a minimally invasive technique : modified vestibular incision subperiosteal tunnel access(m-VISTA).
OBJECTIVES
PRIMARY OBJECTIVES
- To analyze relation and association at 3 and 6 months outcomes in terms of CRC, mRC and gingival margin position with baseline parameters including width of keratinized tissue and width of attached gingiva, after providing mucogingival plastic surgery in the form of m-VISTA+CTG for the treatment of RT1recession defects.
- To evaluate 3 and 6 months outcomes (percentage of root coverage, width of keratinized tissue and width of attached gingiva), after providing mucogingival plastic surgery in the form of m-VISTA+CTG for the treatment of RT1recession defects.
- To access the long-term stability of gingival margin achieved from 3 months to 6 months.
SECONDARY OBJECTIVES
- To access recession depth (RD), recession width (RW), probing pocket depth (PPD), mid buccal clinical attachment loss (bCAL), change in gingival thickness (GT) at baseline, at 3 months and 6 months.
- To access patient related outcomes measures (PROM) in pain and hypersensitivity in teeth with gingival recession undergoing recession coverage.
연구 개요
상태
정황
상세 설명
Recent longitudinal evidence suggests that soft tissue thickness may play a more decisive role in long-term stability than keratinized tissue width (KTW) alone. The baseline keratinized tissue width necessary to achieve stable outcomes remain lacking as the scarcity of cases presenting with minimal or no keratinized tissue width limited the exploration of its influence on achieving complete root coverage in scenarios characterized by extremely reduced or absent keratinized tissue width.
Furthermore, attached gingiva width (AGW) has been insufficiently studied despite its proposed biological relevance in providing functional connective tissue attachment to the underlying hard tissues. In recent randomized controlled trial attached gingiva width was considered along with root coverage percentage as a primary outcome in evaluating collagen matrix (CM) versus connective tissue graft with modified coronally advanced tunnel technique in isolated RT1 cases. A recent study in which anatomical factors affecting root coverage among mandibular incisors were studied and presented limitations such as restricted inclusion of sites, presenting type of recession defects and limited cases with minimal or absent keratinized tissue, thereby limiting its ability to define its absolute indication or minimum requirement for successful root coverage. Collectively, these limitations were particularly related to inclusion of mandibular sites. On perusal of literature revealed there is no prospective study in which baseline keratinized tissue width and attached gingiva width as prognostic factors for root coverage were studied.
Therefore, the aim of this prospective clinical study is to determine if anatomical factors such as keratinized tissue width and attached gingiva width influence recession defects coverage of RT1 recession treated with minimally invasive surgical technique along with connective tissue graft.
Details of Methodology
- Study design and setting The present clinical trial will be conducted in the department of Periodontics, Post Graduate Institute of Dental Sciences, Rohtak, Haryana.
- Study period- up to 24 months
- Study subjects The sample size was calculated using G*Power software to achieve 80% statistical power for detecting a significant correlation of r = 0.5 using a linear regression model based on the previously conducted prospective study. The analysis indicated that 26 patients were required. To compensate for an anticipated 10% dropout rate, the sample size was increased, resulting in a final required sample size of 30 participants.
e. Method of recruitment The study will recruit systematically healthy patients exhibiting Millers class Ⅰ and Ⅱ or RT1 recession defects in maxillary and mandibular anterior teeth from the periodontology outpatient department.
f. Intervention Scaling and root planing Following selection, all the patients will be subjected to phase I therapy, which included full mouth scaling and root planing using ultrasonic scalers and hand instrumentation.
Surgical procedure Connective Tissue Graft Harvesting (Single Incision Technique) After local anesthesia, a single horizontal incision was made 2 mm from the gingival margin of maxillary premolars using a #15 blade (90° to bone). A partial thickness dissection was performed through the same incision to create an undermined area of required size. The connective tissue graft was then outlined with mesial, distal, and medial incisions, separated, and removed using a periosteal elevator. The donor site was closed with horizontal suspension sutures.
m-VISTA Technique : After local anesthesia and root planing, a small vestibular incision was made near the MGJ using a 15C blade. A full-thickness subperiosteal tunnel was created and extended beneath adjacent papillae. An SCTG was inserted through the incision, positioned under the recession area, and the gingivo-papillary complex was coronally advanced and secured with monofilament sutures.
Post operative care Suitable antibiotics and analgesics will be prescribed for 5 days. Chlorhexidine (0.12%) mouthwash for a week. The Coronally attached bonded sutures will be removed after 3 weeks.
Follow up All patients will be recalled for recording of all the clinical parameters at 3and 6 months.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Shikha Tewari, MDS
- 전화번호: +919416514600
- 이메일: drshikhatewari@yahoo.com
연구 연락처 백업
- 이름: Tewari
- 이메일: richatirkey16@gmail.com
연구 장소
-
-
Haryana
-
Rohtak, Haryana, 인도, 124001
- 모병
- Post Graduate Institute of Dental Sciences
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연락하다:
- Shikha Tewari, MDS
- 전화번호: +919416514600
- 이메일: drshikhatewari@yahoo.com
-
연락하다:
- Richa Tirkey, BDS
- 전화번호: +918210892921
- 이메일: richatirkey16@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients with Millers class Ⅰ and II / RT1 isolated recession defects in labial maxillary and mandibular anterior teeth region.
- Recession depth ≥2mm
- Systemically healthy individuals.
- Age >18 years old.
- Full mouth bleeding and plaque score ≤20%
- Patients who agreed to participate in the study and signed an informed consent form.
Exclusion Criteria:
- Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
- Patient with active periodontal disease
- Smokers and tobacco users
- Mal-aligned tooth with recession.
- Patients who had already undergone root coverage procedure on the selected site.
- Pregnant and lactating females
- Involved tooth with trauma from occlusion.
- Involved tooth with prosthesis.
- Endodontically involved/ RCT treated tooth
- Tooth with cervical abrasion / undetectable CEJ/ carious
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: treatment of RT1 gingival recession defects using m-VISTA with connective tissue graft
|
the aim of this prospective clinical study is to determine if anatomical factors such as keratinized tissue width and attached gingiva width influence recession defects coverage of RT1 recession treated with minimally invasive surgical technique along with connective tissue graft. Keratinized tissue width and attached gingiva width are considered important for maintaining gingival health and long-term stability after root coverage. However, there is limited and unclear evidence on how much keratinized or attached gingiva is actually needed for successful root coverage. Most previous studies have focused on soft tissue thickness rather than these parameters. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
root coverage
기간: 6 months
|
root coverage will be calculated in percentage
|
6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Richa Tirkey, PGIDS Rohtak
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Dr. Richa Tirkey Periodontics
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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