Effect of a Volumetrically Stable Xenogeneic Collagen Matrix on the Peri-implant Tissues of Immediate Post-extraction Implants: a Randomized Controlled Clinical Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Analyze the volumetric dimensional changes between the test and the control group
研究概览
简要总结
The present clinical trial will try to demonstrate the efficacy of stable xenogeneic collagen matrix in maintaining the vestibular coronal soft tissue volume and the stabilization of mid-buccal margin position in immediate post-extraccion sockets compared with the use of autogenous connective tissue grafts.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adequate oral hygiene (21).
- •Sufficient interocclusal space (≥6 mm) to place a provisional crown without occlusion.
- •Presence of adjacent teeth. Only one tooth gap.
- •Presence of soft tissue and cortical buccal bone of the tooth to be extracted according to the classification of Elian et al. 2007
- •Adequate bone quantity in the apical region of the tooth to be extracted (assessed on the CBCT).
排除标准
- •Patients with medical conditions that affect bone and soft tissue metabolism.
- •Uncontrolled endocrine disorders.
- •Alcohol and drug abuse.
- •Previous history of immunodeficiency syndromes.
- •Patients who smoke> 10 cigarettes a day.
- •Active periodontal disease.
- •Absence of a tooth adjacent to the tooth to be treated.
- •Oral lesions of the untreated mucosa.
- •Recent previous history (<6 months) of local radiotherapy or chemotherapy.
- •Bruxism or severe parafunctions.
- •Pregnant patients.
研究组 & 干预措施
Xenogenic collagen matrix
Volumetrically stable xenogenic collagen matrix
干预措施: Xenogenic collagen matrix (Device)
Autogenous connective tissue graft
Autogenous connective tissue graft obtained from the tuberosity area
干预措施: Autogenous connective tissue graft (Device)
结局指标
主要结局
Analyze the volumetric dimensional changes between the test and the control group
时间窗: At T12 (12 months after extraction).
Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.
Analyze the volumetric dimensional changes between the test and the control group
时间窗: At T0(initial) before extraction
Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.
Analyze the volumetric dimensional changes between the test and the control group
时间窗: At T6 (6 months after extraction)
Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.
次要结局
- Analyze the mid-vestibular gingival level of the treated tooth.(At T12 (12 months after extraction).)
- Measure the band of keratinized tissue around the treated tooth(At T12 (12 months after extraction).)
- Assessment of pain during surgery in both groups(After 10 days after surgery)
- Quantification of the analgesic medication intake by patients in both groups(At 10 days after the surgery.)
- Comparison of the total surgical time used in each group.(At the day of the surgery)
- Comparison of the economic costs for each patient in the collection of the autologous graft and its application versus the purchase of the Fibrogide and its application.(At the day of the surgery)
- Analyze patient satisfaction between groups(At T12 (12 months after the extraction).)
- Analysis of possible complications in both groups.(They will be reported anytime during the study)
- Evaluation of implant success in both groups at one year of follow-up(At T12 (12 months after the extraction))
- Analyze the mid-vestibular gingival level of the treated tooth.(At T0(initial) before extraction)
- Measure the band of keratinized tissue around the treated tooth(At T6 (6 months after extraction))
- Analyze the mid-vestibular gingival level of the treated tooth.(At T6 (6 months after extraction))
- Measure the band of keratinized tissue around the treated tooth(At T0(initial) before extraction)
- Assessment of pain during surgery in both groups(At the day of the surgery)
- Analyze patient satisfaction between groups(At T0 before extraction.)
研究者
Octavi Ortiz Puigpelat
Principal investigator
Universitat Internacional de Catalunya