跳至主要内容
临床试验/NCT03207971
NCT03207971Unknown不适用

ANALISYS OF MULTIPLE GINGIVAL RECESSION TREATMENT WITH SUBEPITHELIAL CONNECTIVE TISSUE GRAFT REMOVED FROM PALATAL AREA WITH PREDOMINANCE OF LAMINA PROPRIA AND PREDOMINANCE OF SUBMUCOSA: CLINICAL EVALUATION AND LASER DOPPLER FLOWMETRY

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年2月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Total root coverage measured with a periodontal probe in mm

研究概览

简要总结

Subepithelial connective tissue graft (SCTG) is considered the gold standard treatment for root coverage in Miller Class I and II single gingival recession. Therefore, scientific evidence is limited for multiple gingival recessions, only with extrapolation from single-tooth data. Depending on area and depth during the removal of the graft from palate, connective tissue presents different anatomic characteristics, geometric shapes and histological composition. Possibly different types of SCTGs present distinct volumetric stability and physiological process of revascularization. This randomized, split-mouth, double blind clinical trial aim to evaluate periodontal parameters (complete root coverage, gingival recession depth and width, gingival thickness, width of keratinized tissue, probing depth, clinical attachment, plaque and bleeding index) and gingival blood flow in recipient sites, comparing sites that received SCTG from palatal area with predominance of lamina propria and predominance of submucosa. Clinical measurements will be evaluated at baseline and 3, 6 and 12 months after surgical procedure. Blood flow flowmetry with laser doppler (LDF) will be analyzed at baseline and 3, 7,14 and 28 days after surgery. Participants will be invited to answer a questionnaire of aesthetic satisfaction and symptoms of pain and discomfort. Two experienced periodontists blind to experimental groups will be invited to observe the clinical outcomes and answer an aesthetic questionnaire. Data analysis will be performed by paired t-test if follow normal distribution or Wilcoxon if follow nonnormal distribution with significance level of 5% (p <0.05).

详细描述

This will be a randomized, double-blind, split-mouth clinical trial lasting 12 months. Participants will be selected from the Department of Periodontology of the Faculty of Dentistry of Bauru (FOB-USP). The sample will consist of systemically healthy individuals aged between 18 and 70 years. Patients will be included in the study if they meet the following inclusion criteria: (1) clinical diagnosis of multiple gingival recessions with at least one gingival recession ≥ 2 mm, including canines and premolars; (2) Miller class I and II gingival recession areas; (3) non-abrasive, erosive or carious root surfaces (4) unrotated, non-extruded and non-movable teeth (5) systemically healthy patients without contraindication to periodontal surgical procedures. The exclusion criteria will be: smokers, pregnant women, patients with a history of periodontal disease or recurrent abscess formation, patients previously submitted to surgical procedures for root coverage, patients taking anti-convulsant drugs, antihypertensives, contraceptives or immunosuppressors, patientes with low oral hygiene (plaque and bleeding index over 20%). The experimental protocol will be sent to the FOB-USP Human Research Ethics Committee for evaluation. Participants will receive detailed information about the study and will sign the Informed Consent Form after understanding all the steps of the research. All selected patients will be submitted to basic periodontal procedures (scaling, root planning, coronary polishing and oral hygiene instructions) before performing the surgical procedures. Patients should present plaque index and bleeding ≤ 20% throughout the study period.

Surgical Procedures

The experimental groups (A and B) will be treated through the association of subepithelial connective tissue graft (SCTG) and coronally advanced flap. Each individual will receive the types of treatment, randomly assigned to the right or left side. Group A will receive the submucosal predominant area for SCTG (removed from the anterior region of the lateral palate, more deeply) by the double-blade technique (Harris, 1997). This collection method allows a uniformity of the SCTG with standard thickness (1.5mm). Thus, the scalpel cable with double blades (1.5mm distance) will be used. The initial horizontal incision will be made on the palate, preserving 1-1.5 mm from the gingival margin of the teeth, until the complete deepening of the number 15C blades in the necessary extension previously defined for the receiving area. Internal vertical incisions will be performed for both sides of the horizontal incision and at the base of the graft to enable the SCTG removal. After the graft removal, the epithelial portion is extracted for subsequent stabilization of the graft to the recipient site.

Group B will be the one who will receive a graft whit a predominance of lamina propria (removed from the posterior region of the lateral palate, more superficially) by the technique of the deepithelialized graft. Two horizontal and two vertical incisions will be performed on the palate according to the extension needed for the recipient area, preserving 1-1.5 mm from the gingival margin of the teeth. These incisions will be made perpendicular to the palatine dome. Subsequently, for complete removal of the epithelial graft, an incision will be made with the 15 C blade, parallel to the palatal surface. The graft should be approximately 2 mm thick and after removal of the entire epithelium, the thickness should be 1.5 mm, measured with the anesthetic needle with endodontic stop and a digital pachymeter. The removal of the epithelium will be performed with the aid of reflector light (epithelium is firmer and more rugged and connective tissue, more flexible and soft) parallel to the surface of the graft. The difference in light reflection (epithelium reflects more than connective tissue) allows one to distinguish whether it has been removed (Zuchelli et al., 2010).

The width of the graft will be calculated according to the amount of tissue needed to cover the exposed roots plus mesial and distal 3mm and the amount of tissue required for the biopsy. The graft height will be the distance from the enamel cement junction (ECJ) to the buccal bone crest (Zuchelli et al., 2010). A small biopsy of the grafts (approximately 2mm x 6mm) will be removed for histomorphometric analysis. The donor area will be sutured with silk thread 4.0.

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

入选标准

  • clinical diagnosis of multiple gingival recessions with at least one gingival recession ≥ 2 mm, including canines and premolars; (2) Miller class I and II gingival recession areas; (3) non-abrasive, erosive or carious root surfaces (4) unrotated, non-extruded and non-movable teeth (5) systemically healthy patients without contraindication to periodontal surgical procedures -

排除标准

  • : smokers, pregnant women and infants, patients with a history of periodontal disease or recurrent abscess formation, patients previously submitted to surgical procedures for root coverage, patients taking anti-convulsant drugs, antihypertensives, contraceptives or immunosupressors, pacientes with low oral hygiene (plaque and bleeding index over 20%)

结局指标

主要结局

Total root coverage measured with a periodontal probe in mm

时间窗: One year

Distance from cemento-enamel junction to gingival margin = 0 mm

次要结局

  • Keratinized mucosa width measured with a periodontal probe in mm(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ricardo Rabelo Eustachio

Master of science student

University of Sao Paulo

研究点 (2)

Loading locations...

相似试验

ASSESSMENT OF CLINICAL PARAMETERS AND LASER DOPPLER... | 临床试验