Department of Periodontology, Shanghai Stomatological Hospital & School of Somatology, Fudan University, Shanghai, China.
Department of Oral and Maxillary Surgery, Shanghai Stomatological Hospital & School of Somatology, Fudan University, Shanghai, China.
BMJ Open. 2023 Jul 24;13(7):e070958. doi: 10.1136/bmjopen-2022-070958.
Guided tissue regeneration (GTR) combined with bone grafting for periodontal regenerative surgery has ideal clinical results for intrabony defect. However, some sites of intrabony defects often suffer from insufficient keratinised gingival width, which affects the efficacy and long-term prognosis of periodontal tissue regeneration. Free gingival graft (FGG) is an effective surgical procedure to widen the keratinised gingiva, but there are few clinical studies on FGG prior to GTR combination with bone grafting to improve clinical outcomes.
This study is an open-label randomised controlled trial. 68 patients with periodontitis with at least one intrabony defect depth with ≥3 mm are recruited and randomly grouped. In the test group, FGG is performed first, followed by GTR and bone grafting 3 months later; while in the control group, only periodontal tissue regenerative procedures are performed. After completion of all procedures, the patients will be recalled at 3 months, 6 months and 12 months and the relevant clinical and radiographic examinations will be carried out and statistical analysis of the data will also be performed. The present research has received approval from the Ethics Committee of Shanghai Stomatological Hospital (No.2022-007) on 4 August 2022.
Exploring the effectiveness of the two-stage approach of FGG prior to periodontal tissue regenerative surgery for the treatment of keratinised gingival width deficient intrabony defects can provide a high-level evidence-based basis for the formulation of relevant treatment strategies in clinical practice.
The present research has received approval from the Ethics Committee of Shanghai Stomatological Hospital (No.2022-007) on 4 August 2022. The patients will be incorporated into this trial only after their written informed consent has been obtained. The study will be performed according to the 2013 revision of the Helsinki Declaration of 1975. Personal information of all subjects will be stored in the Department of Periodontology of Shanghai Stomatological Hospital. Data of the present research will be registered with the Clinical Trials Registry Platform. Additionally, we will disseminate the results through scientific journals.
Chinese Clinical Trial Registry, ID: ChiCTR 2200063180. Registered on 1 September 2022.
引导组织再生（GTR）联合骨移植治疗牙周再生手术对牙槽骨缺损具有理想的临床效果。然而，一些牙槽骨缺损部位往往存在角化龈宽度不足的问题，这会影响牙周组织再生的疗效和长期预后。游离龈瓣移植（FGG）是一种有效增加角化龈宽度的手术方法，但在 GTR 联合骨移植以改善临床效果之前，关于 FGG 的临床研究较少。
本研究为一项开放性、随机对照试验。共纳入 68 例患有牙周炎且至少有一个牙槽骨缺损深度≥3mm的患者，并将其随机分组。在试验组中，首先进行 FGG，然后在 3 个月后进行 GTR 和骨移植；而在对照组中，仅进行牙周组织再生治疗。所有治疗完成后，患者将在 3 个月、6 个月和 12 个月时进行随访，并进行相关的临床和影像学检查，同时对数据进行统计分析。本研究于 2022 年 8 月 4 日获得上海口腔医院伦理委员会的批准（编号：2022-007）。
探索 FGG 联合牙周组织再生手术治疗角化龈宽度不足的牙槽骨缺损的两阶段方法的有效性，可以为临床实践中制定相关治疗策略提供高质量的循证医学依据。
本研究于 2022 年 8 月 4 日获得上海口腔医院伦理委员会的批准（编号：2022-007）。只有在获得患者书面知情同意后，患者才会被纳入本试验。本研究将按照 1975 年《赫尔辛基宣言》的 2013 年修订版进行。所有受试者的个人信息将存储在上海口腔医院牙周科。本研究的数据将在中国临床试验注册中心注册，注册号为 ChiCTR2200063180。此外，我们将通过科学期刊传播研究结果。
中国临床试验注册中心，注册号：ChiCTR2200063180。注册于 2022 年 9 月 1 日。
