The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession.
2026년 8월 30일 업데이트: Mai Magdy Abu El Eneen, Cairo University
The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession: A Randomized Clinical Trial
The aim of this randomized clinical trial will be to assess the change in recession depth after using a vertically coronally advanced flap with sub-epithelial connective tissue graft compared to a coronally advanced flap with sub-epithelial connective tissue graft after 6 months.
연구 개요
상태
아직 모집하지 않음
상세 설명
To test new approaches for root coverage for the treatment of RT1 and RT2 gingival recession.
연구 유형
중재적
등록 (추정된)
26
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Mai Magdy Abu El Eneen, PHD candidate
- 전화번호: 0201123864563
- 이메일: mai.abueleneen@dentistry.cu.edu.eg
연구 장소
-
-
-
Cairo, 이집트, 11562
- Faculty of dentistry cairo ubiversity
-
연락하다:
- Mai Abu El Eneen, PHD candidate
- 전화번호: +201123864563
- 이메일: mai.abueleneen@dentistry.cu.edu.eg
-
-
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:
• Age ≥ 18 years.
- Systemically healthy.
- Non-smokers.
- Full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
- Presence of identifiable CEJ.
- Absence of non-carious cervical lesions.
- Mature permanent tooth in the aesthetic zone.
- At least one recession defect type RT1 and/ or RT2 in the upper or lower jaw.
- Thin gingival phenotype (GT < 0.8 mm) via probe transparency method.
- A minimum of (2 mm KTW).
Exclusion Criteria:
- Any systemic disease.
- Pregnancy or lactation.
- Cairo RT3 recession defects.
- Teeth with active orthodontic treatment.
- Previous periodontal surgery in the area.
- Use of any drugs that might lead to gingival enlargement.
- Smoking.
- Caries, restoration, mobility, unstable endodontic condition, and malocclusion in teeth undergoing treatment.
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: Coronally Advanced flap combined with sub-epithelial connective tissue graft
The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures
|
The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures
|
|
실험적: Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft
Vertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects.
The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage.
|
Vertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects.
The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in recession depth (mm)
기간: at Baseline and 6 months
|
Change in recession depth in millimeters will be measured using a UNC-15 periodontal probe as the distance from the cementoenamel junction towards the most apical extension of the gingival margin
|
at Baseline and 6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Gingival Recession Width (mm)
기간: at baseline and 6 months
|
Gingival recession width will be measured in millimeters using a UNC-15 periodontal probe as the distance from the base of the mesial to the distal papillae along the cementoenamel junction.
|
at baseline and 6 months
|
|
Keratinized Tissue Width (mm)
기간: at Baseline and 6 months
|
Keratinized tissue width will be measured in millimeters using a UNC-15 periodontal probe from the gingival margin at the deepest recession point till the mucogingival junction (MGJ), which will be identified using the roll technique
|
at Baseline and 6 months
|
|
Keratinized Tissue Height (mm)
기간: at Baseline and 6 months
|
Keratinized tissue height will be measured in millimeters using a UNC-15 periodontal probe from the gingival margin to the mucogingival junction.
|
at Baseline and 6 months
|
|
Probing Depth (mm)
기간: at Baseline and 6 months
|
Probing depth will be measured in millimeters using a UNC-15 periodontal probe as the distance from the base of the gingival crevice to the marginal gingiva.
|
at Baseline and 6 months
|
|
Gingival Thickness (mm)
기간: at Baseline and 6 months
|
Gingival thickness will be measured in millimetres using endodontic spreader no. 15 with a silicon disk stopper will be performed apical to the gingival margin by 2 mm at the middle of the long axis of the tooth mesio-distally using a UNC-15 periodontal probe.The depth of penetration will be measured using a ruler with precision up to the nearest 0.5 mm.
|
at Baseline and 6 months
|
|
Recession Reduction (mm)
기간: at Baseline and 6 months
|
Recession reduction will be calculated by comparing the initial gingival recession depth and gingival depth after treatment using a UNC-15 periodontal probe.
|
at Baseline and 6 months
|
|
Clinical Attachment Level (mm)
기간: at Baseline and 6 months
|
Clinical attachment level will be identified using a UNC-15 periodontal probe as the distance from the cementoenamel junction to the bottom of the gingival sulcus.
|
at Baseline and 6 months
|
|
Complete Root Coverage (%)
기간: at 6 months
|
Complete root coverage will be assessed by calculating the percentage of cases exhibiting a gingival margin that was either level with or positioned coronally to the cementoenamel junction in each group.
|
at 6 months
|
|
Bleeding on Probing (+/-)
기간: at Baseline and 6 months
|
Bleeding on probing (BOP) will be measured using an UNC-15 periodontal probe, gently probing the gingival crevice, beginning inter-proximally from the mesial aspect and moving towards the distal.
A positive finding for BOP will be recorded when bleeding occurred within 10s.
|
at Baseline and 6 months
|
|
Plaque Index (scores 0, 1, 2, 3)
기간: at Baseline and 6 months
|
Plaque index will be determined by drying the teeth in each quadrant with a gentle air blast, where the visibility of dental plaque and supragingival calculus will be noted. Each four tooth surfaces (buccal, lingual, mesial and distal) will be scored from 0 to 3, then scores of the four areas will be added and divided by four to give the average plaque index for each tooth. Scores: 0 : No plaque 1 : A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin, which can be seen with the naked eye. 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. |
at Baseline and 6 months
|
|
Post-Operative Pain (VAS) Visual Analogue Scale Questionnaire
기간: Surgical day and days 1, 3, 7, and 14 after surgery
|
Post-operative pain will be indirectly evaluated on the basis of the mean consumption (in mg) of analgesics (ibuprofen).
A questionnaire will be given to each patient; it will be divided into two parts to be completed in different time periods: the first part, regarding the post-operative discomfort and bleeding will be completed 1 week after the surgery based on a visual analogue scale of 100 mm.Postoperative pain will be assessed using a 100-mm Visual Analogue Scale, ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), with higher scores indicating greater pain.
|
Surgical day and days 1, 3, 7, and 14 after surgery
|
|
Patient Esthetic Satisfaction (RES) Root Coverage Esthetic Score
기간: at 6 months
|
Patient aesthetic satisfaction will be assessed using the root coverage esthetic score (RES) at the 6 months follow up visit.
The following five parameters will be evaluated: gingival margin level (0 = failure of root coverage; 3 = partial root coverage; 6 = complete root coverage), marginal tissue contour (0 = irregular; 1 = proper), soft tissue texture (0 = presence of scar/keloid; 1 = absence of scar/ keloid), mucogingival junction (MGJ) (0 = MGJ not aligned; 1 = MGJ aligned), and gingival color (0 = color differs from adjacent teeth; 1 = normal color and integration).
A total RES score will be calculated by adding these 5 components
|
at 6 months
|
|
Mean Percentage of Root Coverage (mRC) %
기간: (subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100
|
Mean percentage of root coverage (mRC) will be calculated after 6 months as the percentage reduction in gingival recession depth from baseline to 6 months post-treatment, using the following formula: mRC (%) = [(RD₀ - RD6) / RD₀] × 100, where RD₀ represents the gingival recession depth at baseline and RD6 represents the gingival recession depth at 6 months post-treatment.
|
(subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Mai Magdy Abu El Eneen, PHD candidate, Cairo 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 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2027년 3월 1일
연구 완료 (추정된)
2027년 11월 1일
연구 등록 날짜
최초 제출
2026년 8월 11일
QC 기준을 충족하는 최초 제출
2026년 8월 30일
처음 게시됨 (실제)
2026년 9월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 30일
마지막으로 확인됨
2026년 8월 1일
추가 정보
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. .