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临床试验/NCT02433912
NCT02433912已完成4 期

Clinical Evaluation of Single-stage Advanced Versus Rotated Flaps in the Treatment of Gingival Recessions:Longitudinal, Controlled Clinical Trial.

Universidade Federal Fluminense0 个研究点目标入组 36 人开始时间: 2002年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
36
主要终点
Root coverage

研究概览

简要总结

BACKGROUND: Several procedures have been reported for the surgical correction of gingival recession (GR), including the laterally positioned flap (LPF) and the coronally advanced flap (CAF), performed as single or two-stage procedures without or with, respectively, the preceding placement and healing of a free gingival graft (FGG). The objective of the present report was to compare the efficacy of single-stage LPF and CAF techniques in the treatment of localized maxillary GR defects.

METHODS: Thirty-six patients with Miller class I GR defects were randomly assigned to be treated by either a CAF (n=18) or LPF (n=18). Clinical parameters, including recession height (RECH), the width of keratinized tissue (WKT), probing depth (PD) and vertical clinical attachment level (VAL) were assessed at the mid-buccal site. Visual plaque score (VPS) and bleeding on probing (BOP) were also assessed dichotomously. Clinical recordings were performed at baseline, 6 months and 5 years later. Inter-measurements differences were analyzed with a Chi-square or a Wilcoxon test, with significance set at α<0.05.

详细描述

Population and Experimental Design The study was designed as a randomized, prospective, parallel-arm, 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. 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, Federal Fluminense University, Brazil. The following inclusion criteria were used: adult patients with no contraindications for periodontal surgery, and who had not taken medications known to interfere with periodontal tissue health or healing in the preceding 6 months, exhibiting the presence of Miller class I gingival recessions5 in maxillary incisors, canines or premolars, probing depth (PD) <3mm without bleeding on probing, presenting tooth vitality and absence of caries or restorations in the areas to be treated. 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 defects5, presence of apical radiolucency or caries or restorations in the areas to be treated, and previous lack of cooperation with the maintenance program were also exclusion criteria. Thirty-six patients (10 men and 26 women), with average age of 34 ± 7 years, were included in the present prospective study from June 2002 to December 2006. Sample size was determined by Power analysis, assuming α of .05, two-tailed z value of 1.96 and a standart deviation of 0.72. This calculation indicated that with a sample of 16 subjects, the study would have >90% power to detect a 1-mm difference in recession depth between the two groups.

All patients were subjected to initial periodontal therapy and were adherent to maintenance care for at least six months before the beginning of the study. Treatment included oral hygiene instructions, scaling and root planning where needed, tooth polishing plaque control measures and correction of traumatic tooth brushing technique or other negative habits. All patients were instructed and trained to use a soft toothbrush and to eliminate habits related to the etiology of the recession. Baseline full mouth plaque and bleeding scores were low. Each defect (one defect per patient) was randomly assigned to one of the two treatment modalities employed: coronally advanced flap (CAF)(n=18) or laterally-positioned flap (LPF) (n=18) by the toss of a coin.

Clinical data collection Clinical parameters were assessed as previously described3 at the mid-buccal site from the teeth using the cemento-enamel junction (CEJ) or, when applicable, another defined landmark, as a fixed reference point from which REC was recorded. All measurements were recorded using an UNC #15 periodontal probe (PCPUNC 15 - Hu-Friedy, Chicago, USA) with a rubber stopper by a blinded, trained and calibrated examiner, unaware of the treatment provided, at baseline and 6 months after surgery. Measurements were recorded to nearest higher mm. The point of maximum convexity of the marginal gingival contour - the gingival zenith (GZ) - was employed as the reference for measurements of the gingival margin (GM). Visual plaque score (VPS) and bleeding on probing (BOP) were assessed dichotomously at the mid-buccal location. Recession height (RECH) was measured as the distance from the CEJ to GM. The width of keratinized tissue (WKT) was measured as the distance between the GM and the MGJ. PD was measured as the distance from the GM to the bottom of the gingival sulcus. Probing depth and gingival recession were used to calculate the vertical clinical attachment level (VAL).

Surgical Procedures Before surgery, each patient was given a single dose of 500 mg sodic dipyrone as an analgesic. Intraoral antisepsis was performed with a 0.12% chlorhexidine rinse. Anesthesia was obtained by regional blocks with 2.0% Lidocaine with 1:100.000 epinephrine. Coronally Advanced Flap (CAF). The CAF was designed performing two vertical releasing incisions at both the mesial and distal aspects of the recession to be treated, in such a way that both the proximal papillae were not included as part of the flap. Papillae were never bisected. Beveled vertical incisions were performed in the attached gingiva, avoiding the formation of butt-joints between the flap and adjacent tissues, and were continued several millimeters apically into the alveolar mucosa. The vertical incisions were joined by an intrasulcular incision. In the interproximal area, the papillae were split in a mesio-distal dimension, resulting in a flat surface of connective tissue for contact between the flap tissues and the retained portion of the papillae after repositioning and suturing of the flap. A combined mucoperiosteal-mucosal flap was elevated such that the first 3-4mm coronal aspect of the alveolar bone was exposed, while the remaining buccal bone was still covered by the periosteum and gingival connective tissue. Thorough root planning was performed with hand, rotary and ultrasonic instruments. A fine-grain finishing bur was always used to reduce the convexity of the root surfaces and to remove sharp edges and grooves. After instrumentation, the root surfaces were washed with saline solution to attempt to remove any remaining detached fragments from the defect and surgical field. A complementary horizontal incision was performed on the apical aspect of the flap, releasing it from the attached periosteum. This allowed the elongation and free coronal positioning of the flap. The flap was coronally positioned and maintained in place by means of individual 5.0 monofilament sutures.

Laterally Positioned Flap The surgical procedures for the LPF were performed according standard techniques1. The receptor site was prepared using a surgical blade. Incisions were made in both - mesial and distal - aspects of the recession, in order to remove the epithelial attachment and obtain connective tissue surfaces, which extended several millimeters apically toward the alveolar mucosa. These incisions were carried out to obtain an external bevel on the recipient site of the tooth to be treated, and an internal bevel on the adjacent aspect of the flap in such a way that when the flap was rotated and sutured in the receptor site a buttjoint relationship was not stablished, and a large surface of contact between the connective tissues of the flap and receptor site is established. The excised gingival tissues were removed, and the root surface was then instrumented as described above. The flap design was outlined by two vertical incisions which extended from the horizontal incison to several millimeters apically to the mucogingival junction. A horizontal incision was performed either at the gingival, or 1 - 2mm apically, following the marginal gingival contour, thus joining the vertical incisions. When the donor site was an edentulous site, a beveled linear horizontal incision was performed to optimize the content of keratized tissue in the flap. The flap was elevated as full-thickness in the portion adjacent to the recession and as partial thickness in the portion distal to the recession. Partial-thickness dissection was continued apically and laterally in order to obtain passivity of flap movement and absence of muscle pull or periosteal adhesion. The flap was rotated laterally in order to completely cover the recession defect and extend for approximatelly 1mm coronal to the CEJ. Careful flap suturing was performed in order to position and secure the soft tissues over the root surface by means of sling and simple sutures.

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

入选标准

  • Adult patients with no contraindications for periodontal surgery, and who had not taken medications known to interfere with periodontal tissue health or healing in the preceding 6 months, exhibiting the presence of Miller class I gingival recessions5 in maxillary incisors, canines or premolars, probing depth (PD) <3mm without bleeding on probing, presenting tooth vitality and absence 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 defects5, presence of apical radiolucency or caries or restorations in the areas to be treated, and previous lack of cooperation with the maintenance program were also exclusion criteria.

研究组 & 干预措施

Test - Laterally positioned flap

Experimental

Incisions were made in mesial and distal aspects of the recession, in order to remove the epithelial attachment. The root surface was then instrumented. The flap design was outlined by two vertical incisions which extended from the horizontal incision which was performed either at the gingival, or 1 - 2mm apically, following the marginal gingival contour. The flap was rotated laterally in order to completely cover the recession defect and extend for approximatelly 1mm coronal to the CEJ. Careful flap suturing was performed in order to position and secure the soft tissues over the root surface by means of sling and simple sutures.

干预措施: Test - Laterally positioned flap (Procedure)

Test - Laterally positioned flap

Experimental

Incisions were made in mesial and distal aspects of the recession, in order to remove the epithelial attachment. The root surface was then instrumented. The flap design was outlined by two vertical incisions which extended from the horizontal incision which was performed either at the gingival, or 1 - 2mm apically, following the marginal gingival contour. The flap was rotated laterally in order to completely cover the recession defect and extend for approximatelly 1mm coronal to the CEJ. Careful flap suturing was performed in order to position and secure the soft tissues over the root surface by means of sling and simple sutures.

干预措施: 750 mg paracetamol (Drug)

Test - Laterally positioned flap

Experimental

Incisions were made in mesial and distal aspects of the recession, in order to remove the epithelial attachment. The root surface was then instrumented. The flap design was outlined by two vertical incisions which extended from the horizontal incision which was performed either at the gingival, or 1 - 2mm apically, following the marginal gingival contour. The flap was rotated laterally in order to completely cover the recession defect and extend for approximatelly 1mm coronal to the CEJ. Careful flap suturing was performed in order to position and secure the soft tissues over the root surface by means of sling and simple sutures.

干预措施: chlorhexidine gluconate (Drug)

Control - Coronally advanced flap

Active Comparator

The CAF was designed performing two vertical releasing incisions at both the mesial and distal aspects of the recession to be treated, in such a way that both the proximal papillae were not included as part of the flap. The vertical incisions were joined by an intrasulcular incision. A combined mucoperiosteal-mucosal flap was elevated. Thorough root planning was performed. A complementary horizontal incision was performed on the apical aspect of the flap, releasing it from the attached periosteum. This allowed the elongation and free coronal positioning of the flap. The flap was coronally positioned and maintained in place by means of individual 5.0 monofilament sutures.

干预措施: Control-Coronally positioned flap (Procedure)

Control - Coronally advanced flap

Active Comparator

The CAF was designed performing two vertical releasing incisions at both the mesial and distal aspects of the recession to be treated, in such a way that both the proximal papillae were not included as part of the flap. The vertical incisions were joined by an intrasulcular incision. A combined mucoperiosteal-mucosal flap was elevated. Thorough root planning was performed. A complementary horizontal incision was performed on the apical aspect of the flap, releasing it from the attached periosteum. This allowed the elongation and free coronal positioning of the flap. The flap was coronally positioned and maintained in place by means of individual 5.0 monofilament sutures.

干预措施: 750 mg paracetamol (Drug)

Control - Coronally advanced flap

Active Comparator

The CAF was designed performing two vertical releasing incisions at both the mesial and distal aspects of the recession to be treated, in such a way that both the proximal papillae were not included as part of the flap. The vertical incisions were joined by an intrasulcular incision. A combined mucoperiosteal-mucosal flap was elevated. Thorough root planning was performed. A complementary horizontal incision was performed on the apical aspect of the flap, releasing it from the attached periosteum. This allowed the elongation and free coronal positioning of the flap. The flap was coronally positioned and maintained in place by means of individual 5.0 monofilament sutures.

干预措施: chlorhexidine gluconate (Drug)

结局指标

主要结局

Root coverage

时间窗: 5 years

Root coverage will be measured as the reduction in recession height (RECH). RECH will be measured at baseline RECH1 and after 5 years RECH5. The amount of of root coverage will be measured as REC5x100/REC1.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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