Strip Graft With Xenogeneic Matrix Versus Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa: A Randomized Clinical Trial With Vascular Analysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Changes in peri-implant keratinized mucosa width (mm)
研究概览
简要总结
The primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap (ARF) using a combination of a Strip graft and a Xenogeneic matrix, or with a free gingival graft (FGG), in implants in the second stage with <2 mm of PIKM.
Additionally, as a secondary objective, the investigators compare postoperative blood supply in both recipient and donor sites based on the type of graft obtained. Meanwhile, the investigators evaluate differences between the two groups concerning microcirculation values (perfusion units, PU), soft tissue thickness (STT), volume change, vestibular depth, as well as clinical, aesthetic, and patient-reported outcome measures (PROMS).
详细描述
- BACKGROUND The importance of keratinized tissue around teeth and dental implants is a frequently investigated topic in the literature. The need for an adequate amount of peri-implant keratinized mucosa (PIKM), which is defined as a minimum width of 2 mm is demonstrated according to a recently published systematic review and consensus report.
The standard of care in the PIKM augmentation is the apically repositioned flap (ARF) combined with a free gingival graft (FGG), as it represents a predictable and documented strategy to gain KT width. However, such technique implies the harvest of abundant autogenous grafts, and is frequently associated to sub-optimal aesthetic results due to the poor color mimicry of the grafted tissue.
In light of such limitations, some alternatives based on the use of soft tissue substitutes have been proposed, with the aim of reducing surgical invasiveness through the avoidance of large autogenous grafts and improving aesthetic outcomes.
Among those, the sole use of as xenogeneic collagen matrices (XCM) has been associated with promising clinical outcomes albeit with lesser KT width gains as compared to autogenous FGGs.
Recently, a novel approach called the Strip Technique (ST) has been introduced, where the exposed periosteal bed of a ARF is covered with the combination of a xenogeneic collagen matrix and a 2-3 mm wide strip of autogenous free gingival graft, sutured at the apical border of the matrix. The rationale for this "combined grafting technique" stands on reducing surgical invasiveness and improving color mimicry through the use of a XCM, while providing a source of autogenous keratinizing cells in the apical border of the grafted area to promote better PIKM gains. Albeit this new approach seems promising, there is limited evidence regarding its clinical efficacy and there is a lack of knowledge regarding how the adoption of such combined approach affects the re-perfusion of the grafted tissue and the overall microvascular healing of the surgical site.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 18 years
- •Short-span dental implants in the mandible at second stage with inadequate PIKM (<2 mm) with at least one adjacent tooth mesially
- •Periodontally healthy patients with a pristine or reduced periodontium
- •Plaque index (FMPS) less than 20%.
排除标准
- •Compromised general health status that contraindicates study procedures (≥ASA III);
- •Drug or alcohol abuse;
- •Smoking of > 10 cigarettes per day;
- •Chronic use of corticosteroids, NSAIDs or immunomodulators (any type or dose);
- •Pregnant or lactating women;
- •History of previous mucogingival surgeries in the area of interest
研究组 & 干预措施
Strip graft with Mucograft
An apically repositioned flap is prepared then, a free epithelialized gingival strip graft is harvested from the molar area of the palate and sutured to the apical part of the recipient area. A xenogeneic collagen matrix (Mucograft®. Geistlich Pharma AG, Wolhusen, Switzerland) covers the remaining uncovered part of the periosteal bed.
干预措施: Strip graft with Mucograft (Procedure)
Free gingival graft
Apically repositioned flap is prepared. An epithelialized free gingival graft is harvested from the molar area of the palate, and sutured to the recipient area
干预措施: Free gingival graft (Procedure)
结局指标
主要结局
Changes in peri-implant keratinized mucosa width (mm)
时间窗: Baseline, 1, 3, 6 and 12 months
the apico-coronal linear dimension of the buccal peri-implant keratinized mucosa (PIKM) will be measured with a UNC15 periodontal probe (Hu-Friedy manufacturing, Co., LLC, Chicago, USA) as the linear dimension of the buccal vestibule, from the buccal peri-implant mucosa margin to the mucogingival junction at the mid-buccal aspect of the treated implant and adjacent mesial tooth.
次要结局
- Dehiscence (mm)(post-surgically, at 3, 6 and 12 months after surgery)
- Esthetic analysis(30-day, 3-, 6- and 12-month)
- Vestibule depth (VD) (mm)(Pre-surgically, and at 30 days, 3-6 and 12 months)
- Intra-surgical time(During the surgery)
- Full-mouth bleeding score (FMBS) (%)(Baseline, 1 month, 3 months, 6 and 12 months)
- Probing pocket depth (PPD) (mm)(pre-surgically, at 3, 6 and 12 months after surgery)
- Volumetric changes(Baseline, 14 days, 1 month, 3, 6 and 12 months)
- Intra-surgical parameters(During surgery)
- Anamnesis data(Baseline, through study completion, an average of 1 year)
- Smoking habit(Baseline, through study completion, an average of 1 year)
- Vascularization (in Laser Speckle perfusion units [LSPU])(pre-surgically, post-surgically at 4, 7, 10, 14 and 30 days, and at 3-6 and 12 months)
- Changes in soft tissue thickness (STT) (mm)(Baseline, post-op, 1, 3, 6 and 12 months)
- Full-mouth plaque score (FMPS)(Baseline, 1 month, 3 months, 6 and 12 months)
- Patient reported outcome measures (PROMS)(immediately after the surgery, 12 hours after the surgery, 1 day, 2, 3, 4, 5, 6, 7 days and 2 weeks after the surgery)
- Demographic data(Baseline)