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临床试验/NCT07521566
NCT07521566进行中(未招募)不适用

Histological and Clinical Evaluation of De-epithelialized Connective Tissue Grafts Obtained by Different Methods

Dokuz Eylul University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
48
试验地点
1
主要终点
Presence of Epithelial Remnants

研究概览

简要总结

This randomized controlled clinical study aimed to evaluate the effectiveness of two different de-epithelialization techniques-extraoral scalpel and intraoral radiofrequency (RF)-used in the preparation of de-epithelialized connective tissue grafts (De-CTG) for the treatment of gingival recession. A total of 48 patients were randomly assigned into two groups, and all grafts were applied in combination with coronally advanced flap (CAF) surgery. Clinical and histological outcomes, including epithelial remnants, root coverage, keratinized tissue gain, surgical duration, and postoperative patient comfort, were assessed. The study seeks to identify a reliable, operator-independent method that minimizes epithelial remnants and improves clinical outcomes and patient experience.

详细描述

Gingival recession, defined as the apical displacement of the gingival margin relative to the cementoenamel junction, is a common clinical condition associated with both functional and esthetic concerns. Subepithelial connective tissue grafts (SCTG) combined with coronally advanced flap (CAF) procedures are widely regarded as the gold standard for root coverage, particularly in patients with thin gingival phenotypes. However, SCTGs may contain undesirable components such as adipose tissue, glandular structures, and neural elements, which can negatively affect graft integration and healing.

To overcome these limitations, de-epithelialized connective tissue grafts (De-CTGs) have been introduced as an alternative, offering a more homogeneous connective tissue composition. Despite their advantages, one of the major challenges associated with De-CTGs is the potential presence of residual epithelial remnants, which may impair healing and compromise clinical outcomes.

Various de-epithelialization techniques have been proposed, including the use of scalpels, burs, lasers, and more recently, radiofrequency (RF) devices. RF technology operates at ultra-high frequencies (3-4 MHz) and has been associated with minimal thermal damage, reduced tissue trauma, faster healing, and improved postoperative comfort compared to conventional methods. However, its application as a de-epithelialization technique in connective tissue graft harvesting for gingival recession treatment has not been previously investigated.

The present study was designed as a randomized controlled clinical trial involving 48 patients with gingival recession defects. Participants were randomly allocated into two groups: in the first group, De-CTGs were prepared using an extraoral scalpel technique, while in the second group, de-epithelialization was performed intraorally using an RF device. All grafts were used in conjunction with CAF surgery.

The outcomes of the study were evaluated through both clinical and histological parameters. Clinical assessments included root coverage, keratinized tissue width gain, probing depth, and clinical attachment level. Histological analysis focused on the presence or absence of epithelial remnants within the grafts. Additionally, surgical time and postoperative patient-reported outcomes, such as pain and discomfort, were recorded to assess patient-centered benefits.

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)

盲法说明

The outcomes assessor was blinded to the group allocation to minimize assessment bias. Due to the nature of the surgical procedures, participants and care providers were not blinded.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Voluntary individuals aged between 18 and 80 years
  • Systemically healthy
  • Non-smokers
  • Patients diagnosed with periodontal health following Phase I therapy, with reduced periodontium both clinically and radiographically
  • Presence of Cairo RT I and RT II gingival recession defects involving maxillary and mandibular anterior and premolar teeth
  • Presence of at least 1 mm of keratinized gingiva
  • Individuals not using any medications that may affect periodontal tissue health or wound healing
  • Absence of any pathology in the palatal mucosa that may interfere with the surgical procedure for connective tissue harvesting

排除标准

  • Teeth with caries, non-carious cervical lesions, or restorations in the gingival recession area
  • Teeth with endodontic pathology
  • Pregnant or lactating women
  • Patients with cardiac pacemakers
  • Teeth where the cementoenamel junction cannot be clearly identified
  • Individuals for whom the use of a radiofrequency device may pose a risk
  • Use of antibiotics or immunosuppressive medications within the last 3 months

研究组 & 干预措施

Extraoral de-epithelialization Group

Experimental

Participants received de-epithelialized connective tissue grafts prepared using an extraoral scalpel technique in combination with coronally advanced flap surgery for the treatment of gingival recession defects.

干预措施: Extraoral de-epithelialization Group (Procedure)

Radiofrequency De-epithelialization Group

Experimental

Participants received de-epithelialized connective tissue grafts prepared using an intraoral radiofrequency (RF) device in combination with coronally advanced flap surgery for the treatment of gingival recession defects.

干预措施: Radiofrequency De-epithelialization (Procedure)

结局指标

主要结局

Presence of Epithelial Remnants

时间窗: At the time of surgery

Histological evaluation of harvested grafts to determine the presence or absence of epithelial remnants after de-epithelialization using scalpel or radiofrequency methods.

Complete Root Coverage

时间窗: 3-6 months

The percentage of gingival recession defects achieving complete root coverage following treatment with de-epithelialized connective tissue grafts prepared using either scalpel or radiofrequency techniques in combination with coronally advanced flap surgery.

次要结局

未报告次要终点

研究者

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

Ayça Muhterem

Research Assistant, Principal Investigator and Periodontologist

Dokuz Eylul University

研究点 (1)

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