Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients. A Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- millimeters of new attachment
研究概览
简要总结
There are some orthodontics treatments that perform risk movements ,and a bone dehiscence may be expected. In that cases mucogingival surgery , such as connective tissue grafts, is necessary prior to tooth movement.
The connective tissue graft in combination with coronal advanced flap is still considered the gold standard , although the use of porcine collagen matrix has obtained promising results for treatment of Miller class I and II recession defects.
Most of the studies report clinical results after a connective tissue graft and there is no evidence about the type of attachment obtained after the graft is performed, a few articles have shown histological results. But, as a rule , a histological study is only performed under exceptional circumstances such as a dental fracture, untreatable decay, tooth extraction for orthodontic reasons, or other reasons.
Most of the techniques results in the formation of a long junctional epithelium and connective tissue attachment with fibers parallel to the root surface. Animals studies have shown a shorter epithelium and a larger new cementum formation after the use of the collagen matrix.
详细描述
The purpose of this study is to confirm that periodontal regeneration happens after mucogingival surgery The principal outcome is compare the millimeters of new attachment create after a connective tissue graft and after the use of a porcine collagen matrix in teeth that have to been extracted (because of the orthodontic planing treatment) after mucogingival surgery .
The secondary outcomes are:
- length of new cementum (histometry results)
- length of the junctional epithelium (histometry results)
- length of connective tissue attachment (histometry results)
- complete root coverage (clinical results)
- width of keratinized tissue
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)
盲法说明
Analyst and Histometry: The statistician and the pathologist does not know which treatment corresponds to each variable.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient in orthodontic treatment ,who needs mucogingival surgery in both hemi arcade and later the tooth adjacent to the graft should be extracted because of the orthodontic planing treatment .
- •The patient must be 18 years or older
- •Patient shows sufficient plaque control (FMPS < 20%).
- •The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent
排除标准
- •General contraindications for dental and/or surgical treatment are present.
- •The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
- •Untreated periodontal conditions
- •Patients not willing to participate
研究组 & 干预措施
Autologous connective tissue graft
Soft tissue harvesting from patient palate
干预措施: autologous connective tissue graft (Other)
collagen matrix
Mucograft collagen matrix manufactured by Geistlich AG, Switzerland Device: Collagen matrix
干预措施: Collagen matrix (Device)
结局指标
主要结局
millimeters of new attachment
时间窗: Change from baseline at following surgery sixth month
histometry assessment
次要结局
- length of connective attachment(Change from baseline at following surgery sixth month)
- complete root coverage(Change from baseline at following surgery sixth month)
- width of keratinized tissue(Change from baseline at following surgery sixth month)
- Length of new cementum(Change from baseline at following surgery sixth month)
- Length of new junctional epithelium(Change from baseline at following surgery sixth month)
研究者
Elena Ruiz de Gopegui Palacios
Principal investigator
University of the Basque Country (UPV/EHU)