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临床试验/NCT06357351
NCT06357351Unknown不适用

Comparative Evaluation of Vestibular Incision Subperiosteal Tunnel Access With Advanced Platelet-rich Fibrin and Collagen Membrane in the Treatment of Gingival Recession Defects

Mansoura University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
试验地点
1
主要终点
Measuring the recession width in millimeter

研究概览

简要总结

To assess the efficacy of minimally invasive Vestibular Incision Subperiosteal Tunnel Access (VISTA) with collagen membrane and Advanced Platelet-rich Fibrin (A-PRF) in the treatment of multiple buccal gingival recession type 1(RT1) Cairo Classification.

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 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •(18-50) years old with at least 2 sites with gingival recession type (RT1) Cairo Classification (GR with no interdental attachment loss). The interdental CEJ is not detectable clinically on the labial surfaces of the teeth.
  • •Recession in the maxillary anterior region ≥1 mm of attached gingiva, pocket depth (PD) of <3 mm, recession depth (RD) ≥2 mm, and gingival index (GI) score ≤
  • •Systemically healthy, willing individuals with good oral hygiene and without contraindications for surgical interventions

排除标准

  • •the presence of severe systematic diseases or immunodeficiency and contraindicated with surgical interventions.
  • •Allergies to medicaments used in the treatment process.
  • •Patients with removable or fixed dentures.
  • •Patients with cervical abrasion, direct and indirect restorations involving the cervical areas of the maxillary anterior.
  • •Participants with smoking, tobacco chewing, and alcohol consumption.
  • •The presence of high frenal attachment and participants who had previously undergone any periodontal surgical procedure or regenerative therapy in the past 1 year at the same site of the planned treatment.

研究组 & 干预措施

VISTA technique and collagen membrane

Experimental

Participants undergo periodontal surgery using the vestibular incision sub-periosteal tunnel access technique (VISTA) and collagen membrane.

干预措施: vestibular incision sub periosteal tunnel access ( VISTA) technique. (Procedure)

VISTA technique and advanced platelet rich fibrin

Experimental

Participants undergo periodontal surgery using the vestibular incision sub-periosteal tunnel access technique (VISTA) and advanced platelet-rich fibrin (A-PRF).

干预措施: vestibular incision sub periosteal tunnel access ( VISTA) technique. (Procedure)

结局指标

主要结局

Measuring the recession width in millimeter

时间窗: baseline, 3 months and 6 months

self-report assessment by using the UNC-15 Periodontal Probe, measured at the level of Cemento-Enamel Junction CEJ.

Measuring the recession depth in millimeter

时间窗: baseline, 3 months and 6 months

self-report assessment by using the UNC-15 Periodontal Probe, measured from the cemento-enamel junction CEJ to the free gingival junction.

Measuring the width of keratinized gingiva in millimeter

时间窗: baseline, 3 months and 6 months

self-report assessment by using the UNC-15 Periodontal Probe. measured from the free gingiva margin to the mucogingival junction.

Mean of root coverage

时间窗: baseline, and 6 months

was measured by the following formula:. Mean root coverage formula: (pre-operative recession depth - post-operative recession depth)/(pre-operative recession depth ) ×100

次要结局

  • Measuring the probing depth(baseline, 3 months and 6 months)
  • Measuring the plaque index(baseline, 3 months and 6 months)
  • Measuring the gingival index(baseline, 3 months and 6 months)
  • Clinical attachment level(baseline, 3 months and 6 months)

研究者

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

Marwa Abdelfattah Elkhamisy

Master candidate

Mansoura University

研究点 (1)

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