Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants in Terms of Volume Gain and Stability Over Time: A Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- soft tissue volume gain
研究概览
简要总结
The purpose of the study is to compare soft tissue volume changes in terms of volume gain and stability around dental implants and PROMS in cases where a sub-epithelial connective tissue graft (SCTG) from the palate, Porcine collagen matrix (CM) or Porcine Acellular dermal matrix (PADM) is used after 3 and 15 months after implant placement.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients referred to Department of Periodontology (CUO) in need of a single implant and need of soft tissue augmentation such as buccal defects, thin biotype, lack of keratinized tissue and aesthetic compromised situation.
- •The patient must be ≥18 years and able to understand the nature of the proposed surgery and must sign an informed consent.
- •The implant must be located between 2 fixed reference points (i.e. clinical crowns).
- •Anterior and premolar teeth (from premolar to premolar).
- •Enough crestal bone width to leave a minimum thickness of 2mm at the buccal bone plate when placing the implant.
- •Palate must have ≥2mm of thickness at premolar area.
- •Full mouth plaque and bleeding score <20%.
排除标准
- •Pregnant or lactation.
- •Active periodontal disease.
- •Previous soft tissue augmentation in the area.
- •Need of guided bone regeneration (GBR) during or after the placement of the implant.
- •Heavy smokers (> 10 cigarettes per day).
- •Local or systemic conditions that would interfere with routine periodontal therapy (non-controlled diabetes mellitus, cancer, HIV, Chronic High dose steroid therapy, bone metabolic diseases, radiation, immunosuppressive disorders, liver function disorder, immunosuppressant disease, autoimmune disease).
- •Allergy to non-steroidal anti-inflammatory drugs.
- •Patients taking medications that cause gingival enlargement.
研究组 & 干预措施
Control Group
Implant placement and prosthetic rehabilitation of the missing tooth
干预措施: Implant Placement (Procedure)
SCTG group
Implant placement, soft tissue augumentation of Connective Tissue Graft (from the palate) (SCTG) at the implant site and prosthetic rehabilitation of the missing tooth.
干预措施: Implant Placement (Procedure)
SCTG group
Implant placement, soft tissue augumentation of Connective Tissue Graft (from the palate) (SCTG) at the implant site and prosthetic rehabilitation of the missing tooth.
干预措施: Soft Tissue graft augmentation (Procedure)
CM group
Implant placement, soft tissue augumentation of porcine collagen matrix (CM) at the implant site and prosthetic rehabilitation of the missing tooth.
干预措施: Soft Tissue graft augmentation (Procedure)
CM group
Implant placement, soft tissue augumentation of porcine collagen matrix (CM) at the implant site and prosthetic rehabilitation of the missing tooth.
干预措施: Implant Placement (Procedure)
PADM group
Implant placement, soft tissue augumentation of Porcine acellular dermal matrix (PADM) at the implant site and prosthetic rehabilitation of the missing tooth.
干预措施: Soft Tissue graft augmentation (Procedure)
PADM group
Implant placement, soft tissue augumentation of Porcine acellular dermal matrix (PADM) at the implant site and prosthetic rehabilitation of the missing tooth.
干预措施: Implant Placement (Procedure)
结局指标
主要结局
soft tissue volume gain
时间窗: after 3 months
Optical scans superposition
次要结局
- soft tissue volume stability(after 15 months)
- Width of keratinized tissue (KT)(at baseline, after 12 weeks and after 15 months.)
- Bleeding on probing (BI)(at baseline, after 12 weeks and after 15 months.)
- Probing depth (PD)(at baseline, after 12 weeks and after 15 months.)
- Patient reported outcome measures (PROMs)(after the surgery procedures (baseline) and after 7 days (suture removal))
- Plaque index (PI)(at baseline, after 12 weeks and after 15 months.)
- Phenotype evaluation (PT)(at baseline, after 12 weeks and after 15 months.)
- Pink Esthetic Score (PES)(After 2 weeks of the definite crown placement (around 16 months))
研究者
Andres Pascual La Rocca
Master in Periodontics program director
Universitat Internacional de Catalunya