A Clinical Comparison of Microsurgical Versus Conventional Surgical Approaches for the Semilunar Coronally Advanced Flap
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Root coverage
研究概览
简要总结
BACKGROUND: The semilunar coronally repositioned flap (SLCRF) has been used for the treatment of recession defects (GR). Recently a microsusgical (MICRO) has been successfully employed with the procedure apparently resulting in improved results, however, no previous controlled clinical study has evaluated the MICRO SLCRF in comparison with SLCRF performed as originally described (MACRO). The objective of the present study was to compare the clinical outcomes of the MICRO and MACRO SLCRF in the treatment of human GR.
METHODS: Fourteen patients, with bilateral Miller class I GR defects were randomly assigned to MICRO or MACRO SLCRF. Clinical parameters, assessed at baseline and 6 months later, included recession height (RECH), recession width (RECW), width of keratinized tissue (WKT), probing depth (PD), clinical attachment level (CAL), pain measurements and esthetic evaluation with the Root Coverage Score (RCS). Inter-measurements differences were analyzed with a Chi-square or a paired t-test, with significance set at α<0.05.
详细描述
Study Population and Experimental Design The study was designed as a randomized, prospective, split-mouth, controlled clinical trial. It was conducted in accordance with the guidelines of the Helsinki Declaration of 1975, as revised in 2000, and after approved by institutional review board approval (CEP CMM/HUAP no 162/2010). Written informed consent was obtained from all patients after thorough explanation of the nature, risks, and benefits of the clinical investigation and associated procedures.
The study population consisted of patients referred for periodontal treatment at the School of Dentistry, Veiga de Almeida University, Brazil. In order to be elegible for the present study, adult individuals met the following inclusion criteria:
- presence of bilateral Miller class I gingival recessions (≤ 3mm)
- at least 2mm of keratinized tissue width (WKT)
- endodontically-vital
- maxillary canines or premolars.
- shallow (<3mm) probing depth (PD)
- no bleeding on probing.
- absence of contraindications for periodontal surgery
- no medications known to interfere with periodontal tissue health or healing
- teeth to be treated free of caries or restorations
Exclusion criteria were:
- presence of untreated periodontal disease
- smokers
- subjects with immunosuppressive systemic diseases (i.e., cancer, AIDS, diabetes)
- Miller class II, III or class IV recession defects,
- presence of apical radiolucency or caries or restorations in the areas to be treated,
- previous lack of cooperation with the maintenance program
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of bilateral Miller class I gingival recessions (≤ 3mm) exhibiting at least 2mm of keratinized tissue width (WKT) in endodontically-vital maxillary canines or premolars.
- •These teeth presented shallow (<3mm) probing depth (PD) without bleeding on probing. Moreover, the elegible individuals demonstrated absence of contraindications for periodontal surgery, and were not being taking medications known to interfere with periodontal tissue health or healing in the preceding 6 months.
- •Experimental teeth were free of caries or restorations in the areas to be treated.
排除标准
- •Patients with untreated periodontal disease, smokers, subjects with immunosuppressive systemic diseases (i.e., cancer, AIDS, diabetes) were not included in the study.
- •Miller class II, III or class IV recession defects, presence of apical radiolucency or caries or restorations in the areas to be treated, and previous lack of cooperation with the maintenance program (as evaluated by unjustified absence from scheduled maintenance visits, continued traumatic tooth brushing technique or faulty plaque control measures).
研究组 & 干预措施
Test - Microsurgical semilunar flap
Semilunar coronally repositioned flap performed under magnification with a surgical microscope.
SLI was carried out following the outline of the gingival margin with a microsurgical blade under (8x) magnification. An ISI was performed mid-facially. Then, a split-thickness dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth. A cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap.
干预措施: MICROSURGERY (Procedure)
Test - Microsurgical semilunar flap
Semilunar coronally repositioned flap performed under magnification with a surgical microscope.
SLI was carried out following the outline of the gingival margin with a microsurgical blade under (8x) magnification. An ISI was performed mid-facially. Then, a split-thickness dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth. A cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap.
干预措施: Dexamethasone (Drug)
Test - Microsurgical semilunar flap
Semilunar coronally repositioned flap performed under magnification with a surgical microscope.
SLI was carried out following the outline of the gingival margin with a microsurgical blade under (8x) magnification. An ISI was performed mid-facially. Then, a split-thickness dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth. A cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap.
干预措施: Chlorhexidine gluconate (Drug)
Control - Conventional Semilunar flap
Semilunar coronally repositioned flap performed without magnification. A semilunar incision (SLI) was carried out with a 15c surgical blade. An ISI was performed mid-facially. Then, a split-thickness dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth. A cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap.
干预措施: MACROSURGERY (Procedure)
Control - Conventional Semilunar flap
Semilunar coronally repositioned flap performed without magnification. A semilunar incision (SLI) was carried out with a 15c surgical blade. An ISI was performed mid-facially. Then, a split-thickness dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth. A cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap.
干预措施: Dexamethasone (Drug)
Control - Conventional Semilunar flap
Semilunar coronally repositioned flap performed without magnification. A semilunar incision (SLI) was carried out with a 15c surgical blade. An ISI was performed mid-facially. Then, a split-thickness dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth. A cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap.
干预措施: Chlorhexidine gluconate (Drug)
结局指标
主要结局
Root coverage
时间窗: 6 months
Distance between the cementum-enamel junction and the gingival margin. Measurements will be performed at baseline (RECH1) and after 6 months (RECH2). The amount of root coverage will be calculated as REC2x100/REC1
次要结局
未报告次要终点