Soft and Hard Tissue Stability After Immediate Tooth Replacement With Implant in Fresh Sockets Grafted With Different Soft Tissue Grafts
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Periimplant marginal recession
研究概览
简要总结
This study evaluates the impact of soft tissue grafts on soft tissue recession following immediate implant, provisional and bone graft placement in compromised sockets. One third of the patients received a collagen matrix (CM group), another third received a connective tissue graft removed from the palate (CTG group) and the final third did not receive any soft tissue graft (CTL group).
详细描述
Preventing soft tissue recession following flapless immediate implant and provisional placement (IIPP) in sockets with facial bone dehiscences is a challenge, mainly in esthetic areas. This study evaluated the impact of soft tissue grafts on peri-implant alterations after 1-year follow-up. Twenty-four patients with one single failing maxillary incisor presenting facial bone dehiscence and receiving IIPP were randomly divided in three groups (n= 8 in each group): Control (CTL); Collagen Matrix (CM); Connective tissue graft (CTG). In addition to soft tissue grafts, all groups were treated with collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen. Clinical, photographic and tomographic analyses were performed at baseline, 6 and 12 months after surgery to evaluate tissue alterations.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a failing maxillary incisor with neighbouring teeth and harmonic gingival contour;
- •Operated area with appropriate palatal/apical bone to install the implant;
- •A buccal wall defect confirmed by cone beam computed tomography;
- •Clinical attachment level > 3 mm;
- •Good oral hygiene with visible plaque index < 20%;
- •No bone loss in the neighbouring teeth;
- •Implant primary stability > 32N
排除标准
- •History of periodontal surgeries in the failing tooth;
- •Occlusal instability;
- •Systemic alterations that could compromise the surgical procedure, such ass smokers, bruxists; drug users; patients with diabetes or pregnants.
- •Active infection involving the gingival margin
- •Patients undergoing radiotherapy in the head and neck area. Patients presented history of bone associated diseases or medication affecting bone metabolism;
研究组 & 干预措施
CTL
No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Bone regeneration (Biological)
CTL
No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Immediate implant (Device)
CTL
No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Tooth extraction (Procedure)
CTL
No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Immediate restoration (Device)
CTL
No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Post operative medication (Drug)
CTL
No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Definitive prosthesis (Device)
CTL
No soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: No soft tissue graft (Other)
CM
Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Collagen matrix graft (Biological)
CM
Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Immediate implant (Device)
CM
Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Tooth extraction (Procedure)
CM
Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Immediate restoration (Device)
CM
Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Bone regeneration (Biological)
CM
Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Post operative medication (Drug)
CM
Patient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Definitive prosthesis (Device)
CTG
Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Connective tissue graft (Biological)
CTG
Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Immediate implant (Device)
CTG
Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Tooth extraction (Procedure)
CTG
Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Immediate restoration (Device)
CTG
Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Bone regeneration (Biological)
CTG
Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Post operative medication (Drug)
CTG
Patient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
干预措施: Definitive prosthesis (Device)
结局指标
主要结局
Periimplant marginal recession
时间窗: 12 months after surgical procedure
Periimplant marginal recession in millimeters 12 months after the surgical procedure.
次要结局
- Questionnaire of Implant survival(12 months)
- Papilla migration(12 months after the surgical procedure)
- Pink esthetic score(12 months after the surgical procedure)
- Soft tissue thickness(12 months after the surgical procedure)
- Bone height(12 months after the surgical procedure)
- Modified pink esthetic score(12 months after the surgical procedure)
- Bone thickness(12 months after the surgical procedure)