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临床试验/NCT02995070
NCT02995070Unknown不适用

The Influence Low Intensity Laser Therapy (LILT) in Connective Tissue Graft for Root Coverage in Smokers. A Controlled Clinical Trial

Universidade Estadual Paulista Júlio de Mesquita Filho2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Percentage of defect coverage

研究概览

简要总结

The aim of this study is to evaluate the influence of therapy with low-intensity laser technique associated with connective tissue graft for root coverage in smokers and compare the results with non- smokers

详细描述

This is a prospective, parallel and controlled clinical trial. The population evaluated in the study was selected at Science and Technology Institute - São José dos Campos, College of Dentistry.

The selected smokers patients will be randomly allocated by a computer generated list into:

Group CTG (n=15): patients who will receive only the connective tissue graft procedure to treat gingival recession and a simulation of laser therapy application (SHAM).

Group CTG+ LLLT (n=15): patients who will receive the connective tissue graft procedure to treat gingival recession plus 8 applications of low-level-laser therapy (LLLT) to treat gingival recession.

All surgeries will be performed by the same expert periodontist. Before the surgical procedure, all patients were enlightened about the causes and consequences of gingival recession and prevention techniques. Factors related to the origin of gingival recession, such as toothbrush trauma and inflammation caused by biofilm, will be controlled through instruction on standardized brushing technique to avoid the influence of other hygiene methods capable of promoting trauma on soft tissues. Standardized dental floss and toothbrushes were given to patients. The surgical technique adopted in the recession defects was the trapezoidal-type of coronally advanced flap (CAF) and the connective tissue graft (CTG) will be removed from palate mucosa . Briefly, a first incision on the palate will be performed perpendicularly to the long axis of the teeth, 2 to 3 mm apical to the gingival margin. The mesial-distal length of the incision will be determined by the length of the graft required to cover the recession. Because the selected recessions were in maxillary canines and premolars, the lengths of the graft varied minimally (10-12mm). The second incision will be made parallel to the first one (1-2 mm apically and parallel to the long axis of the teeth) to separate the subepithelium connective tissue from the epithelial layer. The incision is carried far enough apically to provide a 7- mm height of connective tissue to cover the denuded root surface. Afterward, another incision parallel to the long axis of the teeth starting from the first incision will be performed to separate the subepithelium connective tissue from the periosteum. Then, the connective tissue graft will be removed from the palate as atraumatically as possible. Single sutures will be made on the palate (4-0 silk) and the graft will be sutured on the receptor site. The irradiation will be performed with a Gallium aluminum arsenide laser (GaAlAs) that continuously emitted a wavelength of 660 nm. Thirty milliwatts will be used for 20 seconds and the total applied energy (fluence) will be 15 Joules per cm2 (3 Joules/ per point and an application time of 4 seconds per point).

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting Miller class I or II gingival recession in the maxillary canines or premolars
  • Visible cemento-enamel junction (CEJ) with 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;
  • Patients who agreed to participate and signed an informed consent form.

排除标准

  • Patients presenting systemic problems that would 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;
  • Patients with orthodontic therapy in progress.

结局指标

主要结局

Percentage of defect coverage

时间窗: 6 months

次要结局

  • Root coverage esthetic score(6 months)

研究者

发起方
Universidade Estadual Paulista Júlio de Mesquita Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mauro Pedrine Santamaria

Assistant Professor

Universidade Estadual Paulista Júlio de Mesquita Filho

研究点 (2)

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