Comparative Evaluation of Laterally Closed Tunnel (LCT) Technique and Modified Coronally Advanced Tunnel (MCAT) Technique in the Treatment of Isolated Gingival Recession: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Gingival Recession Depth (RD)
研究概览
简要总结
The goal of this clinical trial is to compare two different tunneling surgical technique in treatment of gingival recession using two different materials.
Participants will be divided into four groups according to the treatments they'll be given.
详细描述
Comparative Evaluation of laterally Closed Tunnel (LCT) Technique and Modified Coronally Advanced Tunnel (MCAT) Technique in the treatment of isolated gingival recession: Randomized controlled clinical trial.
Proposal Submitted in Partial Fulfillment of the Requirements of Doctor of philosophy Degree in Oral Medicine and Periodontology BY Ahmed Mohamed El-Bana B.D.S, MSC (Mansoura University, 2014) Assistant lecturer at Oral Medicine, Periodontology, Oral Diagnosis and Radiology Department 2021
Gingiva represents one of the important defense barriers of the periodontium and any alteration of its conditions may result in detrimental effects on the stability of the periodontium. Gingival recession is a common mucogingival problem that is associated with apical migration of the gingival margin and exposure of the root surface.Various factors are associated with increased incidence of gingival recession such as plaque-induced inflammation, violation of the biological width of the gingiva, aggressive teeth brushing and high frenulum attachment.
Various surgical techniques were described for the treatment of gingival recession from which, the coronally advanced flap (CAF) is one of the most commonly used techniques for root coverage of miller class I, II. Many modifications of CAF have been used to get the best treatment outcomes. The CAF can be used alone or in combination with connective tissue graft [CTG], platelet rich fibrin , enamel matrix derivative or any other regenerative materials. Various systematic reviews have reported the efficacy of CAF as the gold standard protocol for gingival recession treatment especially if used with CTG.
Tension free healing is the main goal to get the ideal results of gingival recession correction, which was difficult to achieve with a coronal displacement of the tunnel. In addition, the vestibular depth distortion was related to the procedures due to tissue tension. Therefore new clinical approaches are warranted to be more predictable and to minimize the post-operative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No systemic diseases or Pregnancy.
- •Smoking < 10 cigarettes/day.
- •Full mouth plaque score <15%.
- •Full mouth bleeding score <15%.
- •Presence of isolated gingival recession defect >2 mm in depth
- •No interproximal attachment loss.
- •No history of previous mucogingival surgeries.
排除标准
- •Sever interproximal alveolar bone loss.
- •Pregnancy and lactation.
- •Heavy smokers.
- •Uncontrolled diabetic patients.
- •Immunocompromised patients.
- •Prosthetic crown at the experimental site.
- •Teeth with cervical caries or abrasion.
- •Presence of infection or gingival abscess related to the surgical area.
- •Bad oral hygiene.
研究组 & 干预措施
The Laterally Closed Tunnel Technique with SCTG
An aseptic field was required for all surgical procedures using povidine iodine. Local anesthesia using 4% articane with 1:100.000 epinephrine was applied.•
- Then specially designed tunneling instruments [devmed] were used through the sulcular incision to create a pouch.
- A microsurgical blade was used at the inner surface of the pouch till sufficient tissue release was achieved.
- Tissue forceps was used to approximate the mesial and distal margin of the gingiva at the pouch margin.
- After harvesting the graft, it was placed at the prepared pouch after root surface biomodification using EDTA gel 24% for 2 minutes and copious rinsing with saline solution.
- SCTG was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: The Laterally Closed Tunnel Technique with SCTG (Procedure)
The Laterally Closed Tunnel Technique with SCTG
An aseptic field was required for all surgical procedures using povidine iodine. Local anesthesia using 4% articane with 1:100.000 epinephrine was applied.•
- Then specially designed tunneling instruments [devmed] were used through the sulcular incision to create a pouch.
- A microsurgical blade was used at the inner surface of the pouch till sufficient tissue release was achieved.
- Tissue forceps was used to approximate the mesial and distal margin of the gingiva at the pouch margin.
- After harvesting the graft, it was placed at the prepared pouch after root surface biomodification using EDTA gel 24% for 2 minutes and copious rinsing with saline solution.
- SCTG was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: The Laterally Closed Tunnel Technique with collagen matrix mucograft (Drug)
The Laterally Closed Tunnel Technique with SCTG
An aseptic field was required for all surgical procedures using povidine iodine. Local anesthesia using 4% articane with 1:100.000 epinephrine was applied.•
- Then specially designed tunneling instruments [devmed] were used through the sulcular incision to create a pouch.
- A microsurgical blade was used at the inner surface of the pouch till sufficient tissue release was achieved.
- Tissue forceps was used to approximate the mesial and distal margin of the gingiva at the pouch margin.
- After harvesting the graft, it was placed at the prepared pouch after root surface biomodification using EDTA gel 24% for 2 minutes and copious rinsing with saline solution.
- SCTG was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: Modified Coronally Advanced Tunnel Technique with SCTG. (Procedure)
The Laterally Closed Tunnel Technique with SCTG
An aseptic field was required for all surgical procedures using povidine iodine. Local anesthesia using 4% articane with 1:100.000 epinephrine was applied.•
- Then specially designed tunneling instruments [devmed] were used through the sulcular incision to create a pouch.
- A microsurgical blade was used at the inner surface of the pouch till sufficient tissue release was achieved.
- Tissue forceps was used to approximate the mesial and distal margin of the gingiva at the pouch margin.
- After harvesting the graft, it was placed at the prepared pouch after root surface biomodification using EDTA gel 24% for 2 minutes and copious rinsing with saline solution.
- SCTG was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft (Drug)
The Laterally Closed Tunnel Technique with collagen matrix mucograft
An aseptic field was required for all surgical procedures using povidine iodine. Local anesthesia using 4% articane with 1:100.000 epinephrine was applied.•
- Then specially designed tunneling instruments [devmed] were used through the sulcular incision to create a pouch.
- A microsurgical blade was used at the inner surface of the pouch till sufficient tissue release was achieved.
- Tissue forceps was used to approximate the mesial and distal margin of the gingiva at the pouch margin.
- After harvesting the graft, it was placed at the prepared pouch after root surface biomodification using EDTA gel 24% for 2 minutes and copious rinsing with saline solution.
- collagen matrix was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: The Laterally Closed Tunnel Technique with SCTG (Procedure)
The Laterally Closed Tunnel Technique with collagen matrix mucograft
An aseptic field was required for all surgical procedures using povidine iodine. Local anesthesia using 4% articane with 1:100.000 epinephrine was applied.•
- Then specially designed tunneling instruments [devmed] were used through the sulcular incision to create a pouch.
- A microsurgical blade was used at the inner surface of the pouch till sufficient tissue release was achieved.
- Tissue forceps was used to approximate the mesial and distal margin of the gingiva at the pouch margin.
- After harvesting the graft, it was placed at the prepared pouch after root surface biomodification using EDTA gel 24% for 2 minutes and copious rinsing with saline solution.
- collagen matrix was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: The Laterally Closed Tunnel Technique with collagen matrix mucograft (Drug)
The Laterally Closed Tunnel Technique with collagen matrix mucograft
An aseptic field was required for all surgical procedures using povidine iodine. Local anesthesia using 4% articane with 1:100.000 epinephrine was applied.•
- Then specially designed tunneling instruments [devmed] were used through the sulcular incision to create a pouch.
- A microsurgical blade was used at the inner surface of the pouch till sufficient tissue release was achieved.
- Tissue forceps was used to approximate the mesial and distal margin of the gingiva at the pouch margin.
- After harvesting the graft, it was placed at the prepared pouch after root surface biomodification using EDTA gel 24% for 2 minutes and copious rinsing with saline solution.
- collagen matrix was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: Modified Coronally Advanced Tunnel Technique with SCTG. (Procedure)
The Laterally Closed Tunnel Technique with collagen matrix mucograft
An aseptic field was required for all surgical procedures using povidine iodine. Local anesthesia using 4% articane with 1:100.000 epinephrine was applied.•
- Then specially designed tunneling instruments [devmed] were used through the sulcular incision to create a pouch.
- A microsurgical blade was used at the inner surface of the pouch till sufficient tissue release was achieved.
- Tissue forceps was used to approximate the mesial and distal margin of the gingiva at the pouch margin.
- After harvesting the graft, it was placed at the prepared pouch after root surface biomodification using EDTA gel 24% for 2 minutes and copious rinsing with saline solution.
- collagen matrix was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft (Drug)
Modified Coronally Advanced Tunnel Technique with SCTG.
- Supraperiosteal incisions was extended to the mucosal level beyond the MGJ to allow sufficient tissue mobility and release.
- The tunnel was extended in all directions around the recession defect to create a sufficient pouch for connective tissue graft stabilization.
- The interdental papilla tunneling adjacent to the defect was a critical step for technique success.
- Then perfect root planning was performed at the denuded root surface to remove the necrotic cementum at the accessible recession defect.
- Subsequently palatal anesthesia was given to harvest palatal SCTG using deepitheliailized free gingival graft (FGG) technique.
- SCTG was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: The Laterally Closed Tunnel Technique with SCTG (Procedure)
Modified Coronally Advanced Tunnel Technique with SCTG.
- Supraperiosteal incisions was extended to the mucosal level beyond the MGJ to allow sufficient tissue mobility and release.
- The tunnel was extended in all directions around the recession defect to create a sufficient pouch for connective tissue graft stabilization.
- The interdental papilla tunneling adjacent to the defect was a critical step for technique success.
- Then perfect root planning was performed at the denuded root surface to remove the necrotic cementum at the accessible recession defect.
- Subsequently palatal anesthesia was given to harvest palatal SCTG using deepitheliailized free gingival graft (FGG) technique.
- SCTG was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: The Laterally Closed Tunnel Technique with collagen matrix mucograft (Drug)
Modified Coronally Advanced Tunnel Technique with SCTG.
- Supraperiosteal incisions was extended to the mucosal level beyond the MGJ to allow sufficient tissue mobility and release.
- The tunnel was extended in all directions around the recession defect to create a sufficient pouch for connective tissue graft stabilization.
- The interdental papilla tunneling adjacent to the defect was a critical step for technique success.
- Then perfect root planning was performed at the denuded root surface to remove the necrotic cementum at the accessible recession defect.
- Subsequently palatal anesthesia was given to harvest palatal SCTG using deepitheliailized free gingival graft (FGG) technique.
- SCTG was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: Modified Coronally Advanced Tunnel Technique with SCTG. (Procedure)
Modified Coronally Advanced Tunnel Technique with SCTG.
- Supraperiosteal incisions was extended to the mucosal level beyond the MGJ to allow sufficient tissue mobility and release.
- The tunnel was extended in all directions around the recession defect to create a sufficient pouch for connective tissue graft stabilization.
- The interdental papilla tunneling adjacent to the defect was a critical step for technique success.
- Then perfect root planning was performed at the denuded root surface to remove the necrotic cementum at the accessible recession defect.
- Subsequently palatal anesthesia was given to harvest palatal SCTG using deepitheliailized free gingival graft (FGG) technique.
- SCTG was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft (Drug)
Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft
- Supraperiosteal incisions was extended to the mucosal level beyond the MGJ to allow sufficient tissue mobility and release.
- The tunnel was extended in all directions around the recession defect to create a sufficient pouch for connective tissue graft stabilization.
- The interdental papilla tunneling adjacent to the defect was a critical step for technique success.
- Then perfect root planning was performed at the denuded root surface to remove the necrotic cementum at the accessible recession defect.
- Subsequently palatal anesthesia was given to harvest palatal SCTG using deepitheliailized free gingival graft (FGG) technique.
- collagen matrix was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: The Laterally Closed Tunnel Technique with SCTG (Procedure)
Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft
- Supraperiosteal incisions was extended to the mucosal level beyond the MGJ to allow sufficient tissue mobility and release.
- The tunnel was extended in all directions around the recession defect to create a sufficient pouch for connective tissue graft stabilization.
- The interdental papilla tunneling adjacent to the defect was a critical step for technique success.
- Then perfect root planning was performed at the denuded root surface to remove the necrotic cementum at the accessible recession defect.
- Subsequently palatal anesthesia was given to harvest palatal SCTG using deepitheliailized free gingival graft (FGG) technique.
- collagen matrix was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: The Laterally Closed Tunnel Technique with collagen matrix mucograft (Drug)
Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft
- Supraperiosteal incisions was extended to the mucosal level beyond the MGJ to allow sufficient tissue mobility and release.
- The tunnel was extended in all directions around the recession defect to create a sufficient pouch for connective tissue graft stabilization.
- The interdental papilla tunneling adjacent to the defect was a critical step for technique success.
- Then perfect root planning was performed at the denuded root surface to remove the necrotic cementum at the accessible recession defect.
- Subsequently palatal anesthesia was given to harvest palatal SCTG using deepitheliailized free gingival graft (FGG) technique.
- collagen matrix was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: Modified Coronally Advanced Tunnel Technique with SCTG. (Procedure)
Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft
- Supraperiosteal incisions was extended to the mucosal level beyond the MGJ to allow sufficient tissue mobility and release.
- The tunnel was extended in all directions around the recession defect to create a sufficient pouch for connective tissue graft stabilization.
- The interdental papilla tunneling adjacent to the defect was a critical step for technique success.
- Then perfect root planning was performed at the denuded root surface to remove the necrotic cementum at the accessible recession defect.
- Subsequently palatal anesthesia was given to harvest palatal SCTG using deepitheliailized free gingival graft (FGG) technique.
- collagen matrix was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material [Vicryl suture], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.
干预措施: Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft (Drug)
结局指标
主要结局
Gingival Recession Depth (RD)
时间窗: 6 months
measured as the distance from the CEJ to the gingival margin.
次要结局
- Root coverage Esthetic Score (RES)(6 months)
- Complete Root Coverage (CRC)(6 months)
- Mean Root Coverage (MRC)(6 months)
- Gingival Biotype Thickness(6 months)
- Apico-coronal Width of Keratinized Tissue (KTW)(6 months)
- Pocket Probing Depth(6 months)
- Clinical Attachment Level(6 months)
- Plaque Index (PI)(6 months)
- Gingival Index (GI)(6 months)
- Bleeding Index (BI)(6 months)
研究者
Ahmed Elbana
Assistant Lecturer,Oral Medicine, Periodontology, Diagnosis and Oral Radiology Department
Mansoura University