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临床试验/NCT02118155
NCT02118155已完成不适用

Connective Tissue Graft Associated or Not With Low Intensity Laser Therapy: A Randomized Clinical Trial

UPECLIN HC FM Botucatu Unesp1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Percentage of root coverage

研究概览

简要总结

The purpose of this study was to evaluate the 6-month outcomes of applying low-intensity laser therapy associated with connective tissue grafts to treat gingival recession.

详细描述

This was a prospective, parallel and controlled clinical trial. The population evaluated in this study was selected at ICT - São José dos Campos, College of Dentistry.

The selected patients were randomly allocated (by a computer generated list) into:

Group CTG (n = 20) - patients who received connective tissue graft to treat gingival recession Group CTG+LILT (n = 20) - patients who received connective tissue graft associated with 8 applications of low-intensity laser therapy to treat gingival recession.

The surgeries, as well as all postoperative follow-up, were performed at the dental clinic of ICT- UNESP. Surgical areas were anesthetized (2% mepivacaine with 1:100,000 epinephrine). Two horizontal incisions were made at right angles to the adjacent interdental papillae, at the level of the CEJ, without interfering with the gingival margins of neighboring teeth. Two oblique vertical incisions were extended beyond the mucogingival junction, and a trapezoidal mucoperiosteal flap was raised up to the mucogingival junction. After this point, a split-thickness flap was extended apically, releasing the tension and favoring coronal positioning of the flap. The exposed root surface was gently scaled and planed to remove any possible irregularities. Afterward, a thin and small connective tissue graft was harvested from the palate using a scalpel with parallel blades (1.0 mm away from each other). The graft was sutured# using single sutures in the papillae, over the root surface, in such a way that covered the CEJ and the recession. Then, the flap was coronally positioned and sutured to completely cover the graft The patients allocated for the test group received the following protocol for laser application: Five (5) points of irradiation were performed, as depicted in Figure 1. The irradiation was performed with a GaAlAs** diode laser that continuously emitted a wavelength of 660 nm. 30 mW was used for 20 seconds, and the total applied energy density (fluence) was 15 J/cm2 (3 J/cm2 per point and an application time of 4 seconds per point)

Clinical parameters were assessed at baseline and 3 and 6 months post-operatively.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •presenting Miller class I or II gingival recession in the maxillary canines or premolars;
  • •visible cemento-enamel junction (CEJ) in the teeth included in the study and pulp vitality;
  • •patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤ 20%;
  • •patients older than 18 years old;
  • •probing depth ˂ 3 mm in the included teeth; 6) patients who agreed to participate and signed an informed consent form

排除标准

  • •patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure
  • •patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure
  • •smokers or pregnant women
  • •patients who underwent periodontal surgery in the area of interest; and 5) patients with orthodontic therapy in progress.

研究组 & 干预措施

Connective tissue graft (CTG)

Sham Comparator

The gingival recession defects were treated by connective tissue graft surgical procedure and received the sham application os low-intensity laser therapy.

干预措施: Connective tissue graft (Procedure)

Connective tissue graft plus laser (CTG+L)

Experimental

The gingival recession defects were treated by connective tissue graft associated with the application of a LILT protocol

干预措施: Connective tissue graft (Procedure)

结局指标

主要结局

Percentage of root coverage

时间窗: 6 months

次要结局

  • Esthetic(6 months)

研究者

发起方
UPECLIN HC FM Botucatu Unesp
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mauro Pedrine Santamaria

PhD

UPECLIN HC FM Botucatu Unesp

研究点 (1)

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