Innovation Technique With Non-pedicled Buccal Fat Pad Graft in the Treatment of Gingival Recessions: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Change in Probing Depth (PD)
研究概览
简要总结
Background: This randomized controlled clinical study of split-mouth aimed to compare non-pedicled buccal fat pad graft (BFPG) with subepithelial connective tissue graft (SCTG) in the treatment of Miller Class I or II gingival recessions.
Methods: Twelve patients with Miller Class I or II (≥ 2 mm) bilateral recessions in maxillary premolars or canines were selected. The recessions were randomly assigned to receive SCTG (Control Group) or BFPG (Test Group). The clinical parameters of Gingival Index (GI), Plaque Index (PI), Probing Depth (PD), Gingival Recession (GR), Clinical Attachment Level (CAL), Width of Keratinized Tissue (WKT), Thickness of Keratinized Tissue (TKT) and Gingival Margin to the Acrylic Guide (GM-AG) were evaluated at baseline, and in the postoperative periods of 1, 3, and 6 months. The percentage of root coverage was also evaluated. Data were submitted to repeated measures ANOVA, Bonferroni method and t-test (p<0.05).
详细描述
MATERIALS AND METHODS
Study population This paper aims to report a randomized controlled clinical study of split-mouth. 12 patients were selected, 8 women and 4 men, aged between 21 and 65 (mean age 41 ± 11.9 years). They were informed about the risks and benefits of this clinical investigation as well as associated procedures, and signed a free and informed consent form. This study was approved by the Ethics and Research Committee of Positivo University (083/2010).
The inclusion criteria for the selection of patients were: 1) patients with Miller Class I or II gingival recessions located bilaterally in the vestibular surface of upper premolars or canines ≥ to 2 mm; 2) patients who had recessions with some differences between the right and the left sides ≤ to 3 mm; 3) non-smokers; 4) non-pregnant patients; 5) systemically healthy patients; 6) periodontally healthy patients with no contraindications for periodontal surgery; 7) patients who did not take any kind of medicine that could interfere with the health of gingival and periodontal tissue; 8) teeth with probing depth (PD) <3 mm and without bleeding on probing (BOP); 9) teeth with no caries or restorations in the cervical region; and 10) region that had not been undergone any periodontal surgery before.
Initial therapy The patients underwent a basic periodontal treatment including scaling, root planing, tooth polishing and oral hygiene instructions as required. Additionally, all patients were included in a pre-treatment program in order to eliminate possible etiological factors related to gingival recession. Patients were instructed to perform a non-traumatic brushing technique by using a toothbrush with soft bristles. The surgical procedure was performed only in patients who had adequate plaque control.
Clinical Parameters After 30 days of initial therapy, the clinical parameters were recorded by a single calibrated operator with professional experience in periodontics, at the beginning (baseline), and in the postoperative periods of 1, 3, and 6 months respectively. The periodontal probe used was North Carolina (UNC-15, Hu-Friedy, Chicago, IL, USA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Miller Class I or II gingival recessions located bilaterally in the vestibular surface of upper premolars or canines ≥ to 2 mm
- •Patients who had recessions with some differences between the right and the left sides ≤ to 3 mm
- •Non-smokers
- •Non-pregnant patients
- •Systemically healthy patients
- •Periodontally healthy patients with no contraindications for periodontal surgery
- •Patients who did not take any kind of medicine that could interfere with the health of gingival and periodontal tissue
- •Teeth with probing depth (PD) <3 mm and without bleeding on probing (BOP)
- •Teeth with no caries or restorations in the cervical region
- •Region that had not been undergone any periodontal surgery before
排除标准
- •Patients who did not meet the inclusion criteria
结局指标
主要结局
Change in Probing Depth (PD)
时间窗: Baseline, 1, 3, and 6 months respectively
measure from the gingival margin (GM) up to the bottom of the gingival sulcus
Change in Gingival Recession (GR)
时间窗: Baseline, 1, 3, and 6 months respectively
measure from the Cemento-Enamel Junction (CEJ) up to the GM
Change in Width of Keratinized Tissue (WKT)
时间窗: Baseline, 1, 3, and 6 months respectively
measure from the Mucogingival Junction (MGJ) up to the GM
Change in Thickness of Keratinized Tissue (TKT)
时间窗: Baseline, 1, 3, and 6 months respectively
measure performed with the aid of a North Carolina periodontal probe (UNC-15, Hu-Friedy, Chicago, IL, USA) perpendicularly placed along the tooth axis in the most central portion of the keratinized tissue, between the GM and the MGJ
Change in Clinical Attachment Level (CAL)
时间窗: Baseline, 1, 3, and 6 months respectively
measure from the CEJ up to the bottom of the gingival sulcus
次要结局
未报告次要终点
研究者
Tatiana Miranda Deliberador
Full Professor
Universidade Positivo