Effect of Healing Xenogenic Biomaterial Exposed to the Oral Environment in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Keratinized Mucosa Width
研究概览
简要总结
The goal of this clinical trial is to compare, the effect of letting the xenogeneic bone graft exposed to the oral environment or seal off the graft with a collagen matrix. Them main questions it aims to answer are:
- The enhancement of soft tissue healing during the initial phases following immediate implant placement.
- The secondary aim is to evaluate the dimensional alterations in hard tissues at immediately placed implants and different biomaterial protocol.
It were selected patients with indication of flapless extraction in posterior teeth, which was placed immediate implant (n=28) and gap filling with deproteinized bovine bone mineral (Geistlich Bio-Oss®). In this study, participants were stratified into two randomized blocks, each corresponding to a distinct surgical technique: left exposed the graft to the oral environment or coverage with a collagen matrix (Geistlich Mucograft®).
- Previously the extraction was performed the measurement of the keratinized gingiva, and after 04 months of implant placement.
- The soft tissue healing was evaluated on days 02, 07, 30 days; by means of a blue-stained solution (methylene blue 0.05%) and standardized photograph.
- In the same date from different healing times it was performed immunoenzymatic analysis of the levels of VEGF (vascular endothelial growth factor), IL-1β (interleukin-1β) and FGF2 (fibroblast growth factor 2).
- It was also be performed cone beam computed tomography images quantifying the soft and hard tissues thickness of the facial and lingual bone wall. The clinical trial examiner was blinded during the study period.
详细描述
The present study aimed to evaluate molecular, histologically and tomographic soft and hard tissue parameters of tissue healing in immediate placement of dental implant and gap filling with Bio-Oss covered (control group), or not (test group) with Mucograft. he hypothesis was that both the test group and the control group would have great results in alveolar preservation.
The implant function successful does not reach the patients and clinicians aesthetic demands, as well the approach and integrity of hard and soft tissue structures, which are compromised by physiological and structural changes after the dental extraction, are challenge in the implant treatment (Chappuis et al., 2017). The alveolar process is tooth dependent, and the dimensional alterations of the alveolar ridge that occurred following tooth extraction in a thin bone phenotype (< 1 mm) is inherent in the healing process, but can be minimized by alveolar preservation (Ten Heggeler et al., 2011; Jung et al., 2013; Sculean et al., 2014; Chappuis et al., 2017; Jung et al., 2018). A systematic review revealed 2.6 to 4.5 mm in width bone loss and 0.4 to 3.9 mm vertically in non-molar regions following tooth extraction (Ten Heggeler et al., 2011). This loss could be reduced from 43.3% to 18.1% by using bone grafts and covering the alveolus with free gingival grafts in a 6-month follow-up (Jung et al., 2018). Several studies focused on bone healing parameters, placing bone substitute materials in alveolar sockets to reduce resorption after tooth extractions. However, soft tissue healing after extraction received little attention in clinical research.
The average and standard deviation of group 1 were 4 and 0.8, respectively, and for group 2, they were 5 and 1. To verify the variation in amount of keratinized tissue considered clinically relevant and different between groups was calculated (GPower 3.1). A sample for a total of 28 immediate implant placement, being equivalent to each group (14 for group 1 and 14 for group 2), taking into account a significance level of 5%, 80% test power and average difference of 1.0 mm between the groups and standard deviation of 20%. The study was a Randomized Controlled Clinical Trial, with clinical procedures conducted by an experienced dentist, and the examiner analyzing the entire trial blinded during the study period.
The selection included patients requiring extraction of at least one posterior tooth due to caries, endodontic complications, periodontitis, orthodontic and prosthetic reasons. Only healthy patients with adequate oral hygiene (bleeding on probing ≤ 10% and plaque), primary stability of at least 35N after implant placement. The exclusion criteria were: age < 18 years, smoking; smoking more than 10 cigarettes per day; presence of relevant medical conditions: diabetes mellitus, unstable or potentially fatal conditions or requiring antibiotic prophylaxis and drug medication that influence bone metabolism; pregnant or lactating women; radiotherapy or chemotherapy for malignancy in the last 5 years; history of autoimmune disease; presence of acute periodontal or periapical pathology; and history of drugs or elitist. . Patients were invited to participate after ethical committee approval, and randomization into blocks was done through an online application.
A comprehensive periodontal examination was conducted before any surgical procedure. Keratinized gingiva width was evaluated using a periodontal probe at the facial level, measuring the distance from the muco-gingival junction and gingival margin before extraction and after 4 months at implant placement. Flapless tooth extraction was performed in the least traumatic way, and dental implants (Straumann SLActive) were immediately placed. The buccal gap was filled with xenogeneic deproteinized bovine bone (Geistlich Bio-Oss®). In the study group, bone grafting was exposed with flap healing by second intention, while in the control group the collagen matrix (Geistlich Mucograft®) was pulled over the healing cap. Standard postoperative instructions were given, and Amoxicillin 875 mg (every 12 hours for 11 days) was prescribed 24 hours before the surgical intervention, along with analgesics every 6 hours for 3 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults (≥18 years-old) exhibiting good oral hygiene,
- •Hopeless molar teeth with an intact buccal socket wall,
- •Sufficient apical bone allowing for immediate implant placement.
排除标准
- •Individuals with systemic diseases that are unstable,
- •Uncontrolled metabolic conditions,
- •Daily smoking habit of ≥10 cigarettes,
- •Those who have received antibiotic drugs or corticosteroids within the past 3 months, or are currently on medications that impact bone healing, such as bisphosphonates,
- •Patients with a past history of chemotherapy or radiation therapy in the oral and maxillofacial region.
结局指标
主要结局
Keratinized Mucosa Width
时间窗: before extraction, after 1-2 months post implant placement, and after the emergence contour of a prosthesis (up to 4 months).
The keratinized mucosa width was evaluated using a periodontal probe at the facial level before extraction and after 4 months at the implant placement.
次要结局
- Cone Beam Computed Tomographs Measurements(Baseline; after 4 months)
研究者
Arthur Belem Novaes Jr
Phd, Ms, DDs. Chairman of Periodontolgy
University of Sao Paulo
