Clinical, Radiographic and Volumetric Evaluation of the Entire Papilla Preservation Technique With and Without Connective Tissue Graft in the Treatment of Periodontal Intraosseous Defects.
2026年7月28日 更新者：Medical University of Warsaw
This study is to assess the impact of implementing subepithelial connective tissue graft (SCTG) in the treatment of periodontal intrabony defects with Entire Papilla Preservation Technique (EPPT) on the clinical and radiographic results after 6 and 12 months.
研究概览
地位
尚未招聘
条件
详细说明
This randomized controlled clinical trial aims to evaluate the clinical, radiographic, and volumetric outcomes of periodontal regenerative treatment using the Entire Papilla Preservation Technique (EPPT) with or without the addition of a subepithelial connective tissue graft (SCTG) in the treatment of intrabony periodontal defects.
Patients will be randomly assigned to receive EPPT combined with enamel matrix derivative (EMD) either with or without SCTG. Clinical, radiographic, and digital volumetric parameters will be assessed at baseline, 6 months, and 12 months to evaluate treatment outcomes.
Exploratory analyses will be conducted to assess the relationship between selected genetic polymorphisms (NLRP2 and IL-1β) and clinical outcomes of periodontal regeneration, including clinical attachment level, probing pocket depth, and gingival recession.
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Małgorzata Wyszyńska-Pomian
- 电话号码：+48 504006984
- 邮箱：malgorzata.wyszynska@wum.edu.pl
研究联系人备份
- 姓名：Bartłomiej Górski
- 电话号码：+48221166431
- 邮箱：bartlomiej.gorski@wum.edu.pl
学习地点
-
-
-
Bialystok、波兰、15276
- Department of Integrated Dentistry, University of Białystok
-
接触：
- Anna Skurska
- 邮箱：annaskurska@wp.pl
-
Szczecin、波兰
- Department of Periodontology, Pomeranian Medical University Contact
-
接触：
- Monika Machoy
- 邮箱：monika.machoy@pum.edu.pl
-
-
Warsaw
-
Warsaw、Warsaw、波兰、00-246
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age ≥ 18 years,
- Good compliance and good oral hygiene
- Systemically healthy
- Isolated two intrabony defects of more than 3 mm depth, combined with more than 6 mm probing depth and attachment loss (stage III/IV periodontitis) and an intrabony radiographic defect depth (DD) ≥ 3 mm, as evaluated on a digital periapical radiograph
- The associated tooth should either maintain normal pulp vitality or should have undergone root canal therapy for at least 6 months before.
Exclusion Criteria:
- Full-mouth plaque score ≥ 20% (O'Leary et al 1972)
- Full-mouth bleeding score ≥ 20% (Cortellini et al 1995)
- Smoking
- Systemic diseases that would adversely influence wound healing
- Medications interfering with post-operative wound healing
- Pregnant and lactating females
- Previous periodontal surgery in the examined area
- III-degree mobility
- Furcation involvement
- Pulpal pathology or inadequate endodontic treatment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Entire Papilla Preservation Technique (EPPT) + EMD
Participants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD).
After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material as needed.
Flaps are repositioned and sutured for primary closure.
|
A microsurgical periodontal regenerative technique aimed at preserving the interdental papilla.
The procedure includes flap elevation, defect debridement, root surface conditioning, application of regenerative materials, and primary wound closure.
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
|
|
实验性的：Entire Papilla Preservation Technique (EPPT) + EMD+ SCTG
Participants receive periodontal regenerative surgery using the Entire Papilla Preservation Technique (EPPT) combined with enamel matrix derivative (EMD) and subepithelial connective tissue graft (SCTG).
After flap elevation and defect debridement, root surface conditioning with EDTA is performed, followed by application of enamel matrix derivative and placement of bone substitute material.
A subepithelial connective tissue graft is harvested and placed at the defect site prior to flap closure.
|
A microsurgical periodontal regenerative technique aimed at preserving the interdental papilla.
The procedure includes flap elevation, defect debridement, root surface conditioning, application of regenerative materials, and primary wound closure.
Application of EDTA gel to the root surface to remove the smear layer and enhance regenerative outcomes.
A biologically active material applied to the root surface after EDTA conditioning to promote periodontal regeneration.
A xenogeneic bone graft material used to support bone regeneration within the intrabony defect.
An autogenous connective tissue graft harvested from the palate and placed at the surgical site to enhance soft tissue thickness and stability.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical Attachment Level gain (CAL, mm)
大体时间：6 months and 12 months
|
Clinical Attachment Level (CAL) gain, measured in millimeters (mm), defined as the change from baseline in the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
|
6 months and 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Probing Pocket Depth (PPD, mm)
大体时间：Baseline, 6 months and 12 months
|
Probing Pocket Depth (PPD), measured in millimeters (mm), defined as the distance from the gingival margin to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
|
Baseline, 6 months and 12 months
|
|
Probing Pocket Depth reduction (PPD, mm)
大体时间：6 months and 12 months
|
Probing Pocket Depth (PPD) reduction, measured in millimeters (mm), defined as the change from baseline in the distance from the gingival margin to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
|
6 months and 12 months
|
|
Clinical Attachment Level (CAL, mm)
大体时间：Baseline, 6 months, and 12 months
|
Clinical Attachment Level (CAL), measured in millimeters (mm), defined as the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, assessed using a calibrated periodontal probe.
|
Baseline, 6 months, and 12 months
|
|
Gingival Recession (GR, mm)
大体时间：Baseline, 6 months and 12 months
|
Gingival recession (GR), measured in millimeters (mm), defined as the distance from the cemento-enamel junction (CEJ) to the gingival margin, assessed using a calibrated periodontal probe.
|
Baseline, 6 months and 12 months
|
|
Keratinized Tissue Width (KTW, mm)
大体时间：Baseline, 6 months and 12 months
|
Keratinized tissue width (KTW), measured in millimeters (mm), defined as the distance from the gingival margin to the mucogingival junction, assessed using a periodontal probe.
|
Baseline, 6 months and 12 months
|
|
Gingival Thickness (GT, mm)
大体时间：Baseline, 6 months and 12 months
|
Gingival thickness (GT), measured in millimeters (mm) at the buccal aspect 3 mm apical to the gingival margin using a standardized transgingival probing method with an endodontic file and stopper.
|
Baseline, 6 months and 12 months
|
|
Soft Tissue Volumetric Change (mm³)
大体时间：6 months and 12 months
|
Change from baseline in soft tissue volume, expressed in cubic millimeters (mm³), assessed by superimposition of digital intraoral scans (STL files) using dedicated software with standardized reference areas.
|
6 months and 12 months
|
|
Radiographic Linear Defect Fill (LDF, mm)
大体时间：6 months and 12 months
|
Linear defect fill (LDF), measured in millimeters (mm), assessed from standardized periapical radiographs using reproducible reference points.
|
6 months and 12 months
|
|
Radiographic Percentage Defect Fill (%DF)
大体时间：6 months and 12 months
|
Percentage defect fill (%DF), expressed as a percentage (%), calculated based on standardized measurements obtained from periapical radiographs using a reproducible measurement protocol to assess bone defect resolution.
|
6 months and 12 months
|
|
Early Wound Healing Score (EHS)
大体时间：1 week and 2 weeks
|
Early wound healing will be assessed using the Early Wound Healing Score (EHS), a composite clinical index ranging from 0 to 10 based on re-epithelialization, hemostasis, and inflammation, with higher scores indicating better healing.
|
1 week and 2 weeks
|
|
Full-Mouth Plaque Score (FMPS, %)
大体时间：Baseline, 6 months, and 12 months
|
Percentage of tooth surfaces with dental plaque, assessed using a standardized plaque index and expressed as a percentage (%).
|
Baseline, 6 months, and 12 months
|
|
Full-Mouth Bleeding Score (FMBS, %)
大体时间：Baseline, 6 months, and 12 months
|
Percentage of tooth surfaces with bleeding on probing, assessed using a standardized method and expressed as a percentage (%).
|
Baseline, 6 months, and 12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Bartłomiej Górski、Depatrment of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2027年9月30日
研究完成 (估计的)
2027年11月30日
研究注册日期
首次提交
2026年4月2日
首先提交符合 QC 标准的
2026年7月28日
首次发布 (实际的)
2026年7月30日
研究记录更新
最后更新发布 (实际的)
2026年7月30日
上次提交的符合 QC 标准的更新
2026年7月28日
最后验证
2026年1月1日
更多信息
与本研究相关的术语
其他研究编号
- Perio.06
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.