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Effectiveness of Xenogenic Collagen Matrix in Modification of Mucosal Phenotype Around Dental Implants

2026年5月5日 更新者：Mansoura University
Aim of the study The rationale for conducting the present study is to evaluate the efficacy of porcine collagen matrix in the management of defective width of keratinized mucosa around dental implant.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

Therefore, the primary objective is to evaluate the integration of porcine collagen matrix with the recipient site and measuring the amount gained of keratinized mucosa. The secondary objective is to assess the pink esthetic score around dental implant following porcine collagen matrix compared to the free gingiva graft.

研究类型

介入性

注册 (估计的)

20

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。

学习地点

  • 埃及
      • Al Mansurah、埃及
        • faculty of dentistry Mansoura university, Mansoura, 35516

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

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Patient between 25-50 years old.
  2. Remaining bone height of more than 8 mm, remaining bone width of 6 mm
  3. Inadequate keratinized soft tissue <2 mm (13).
  4. Favorable pattern of occlusion.
  5. Good oral hygiene.
  6. Patient ability to comply with the required recall visits.

Exclusion Criteria:

  1. Insufficient bone width (less than 6 mm) mesiodistal or buccolingually.
  2. Patients having any uncontrolled systemic disease which could affect bone healing.
  3. Patients treated with radiotherapy to the head and neck area within the past 12 months.
  4. Heavy Smokers (more than 20 cigarette per day) according to WHO.
  5. Inability or unwillingness to return for follow-up visits.

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：dental implant with application of free gingival graft
Group I: will include 10 patients in which participants will receive dental implant with application of free gingival graft which will be taken from the hard palate to increase the width of keratinize gingiva
程序：All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).

Group I: All patients will be operated under local anaesthesia;. .. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. A gingival graft will be taken from the hard palate. The graft will be 1 to 2 mm in thickness and its size will be determined depending on recipient size and free from adipose tissue. The graft will be trimmed to adapt to the shape and size of the recipient site then suturing the graft to the recipient sites by using 4-0 vicryl suture.

Group II: All patients will be operated under the same local anaesthetic as in group I. Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected just to access the site. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. Porcine collagen matrix will be placed in the recipient site and sutured by using 4-0 vicryl suture.
实验性的：dental implants with application of porcine collagen matrix
Group II: will include 10 patients in which participants will receive dental implants with application of porcine collagen matrix to increase the width of keratinize gingiva.
程序：All dental implants will be placed in edentulous the area with application of free gingival graft (Group I) or with incorporation of porcine collagen matrix (Group II).

Group I: All patients will be operated under local anaesthesia;. .. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. A gingival graft will be taken from the hard palate. The graft will be 1 to 2 mm in thickness and its size will be determined depending on recipient size and free from adipose tissue. The graft will be trimmed to adapt to the shape and size of the recipient site then suturing the graft to the recipient sites by using 4-0 vicryl suture.

Group II: All patients will be operated under the same local anaesthetic as in group I. Crestal incision will be performed and full thickness mucoperiosteal flap will be reflected just to access the site. Two vertical releasing incisions delineated the partial thickness flap. The flap will be apically positioned and sutured. Porcine collagen matrix will be placed in the recipient site and sutured by using 4-0 vicryl suture.

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 Evaluation:
大体时间：3 months

Wound Healing Status: Presence or absence of soft tissue dehiscence or wound infection.

Unit: Yes/No. Time Frame: Post-operative follow-up visits.
3 months
clinical
大体时间：3 months

Implant Stability: Implant stability measured using Resonance Frequency Analysis (Osstell).

Unit: Implant Stability Quotient (ISQ). Time Frame: Immediately post-placement and at 3 months.
3 months
Clinical
大体时间：3 months

Surgical Operation Time: Duration of implant site preparation and graft fixation.

Unit: Minutes. Time Frame: During surgery.
3 months
clinical
大体时间：3 months

Post-operative Pain Intensity: Patient-reported pain measured using Visual Analogue Scale (VAS).

Unit: VAS score (0-10). Time Frame: Day 1, Day 3, and 1 week post-operatively.
3 months

次要结果测量

结果测量
措施说明
大体时间
Clinical periodontal parameters
大体时间：3 months

Plaque Index (PI): Dental plaque accumulation around implants measured using the Plaque Index.

Unit: PI score. Time Frame: 3 months post-operatively.
3 months
radiographic
大体时间：6 months

  1. Implant Position Accuracy

    Description:

    Evaluation of the accuracy of dental implant placement in relation to adjacent teeth and surrounding vital anatomical structures using Cone Beam Computed Tomography (CBCT).

    Unit of Measure:

    Deviation distance in millimeters (mm)

    Time Frame:

    At 6 months post-implant placement

  2. Crestal Bone Level Changes - Mesiodistal

    Description:

    Measurement of crestal bone level changes in the mesiodistal direction around the dental implant using CBCT.

    Unit of Measure:

    Millimeters (mm)

    Time Frame:

    At 6 months post-implant placement

  3. Crestal Bone Level Changes - Buccolingual

Description:

Measurement of crestal bone level changes in the buccolingual direction around the dental implant using CBCT.

Unit of Measure:

Millimeters (mm)

Time Frame:

At 6 months post-implant placement
6 months
clinical parameters
大体时间：3 months

Probing Depth (PD): Peri-implant probing depth to assess peri-implant tissue health.

Unit: mm. Time Frame: 3 months post-operatively.
3 months
clinical perodontal parameters
大体时间：3 months

Clinical Attachment Level (CAL): Measurement from cemento-enamel junction to base of peri-implant sulcus/pocket.

Unit: mm. Time Frame: 3 months post-operatively.
3 months
clinical periodontal parameters
大体时间：3 months

Keratinized Tissue Width (KTW): Width of keratinized mucosa around implant site.

Unit: mm. Time Frame: 3 months post-operatively.
3 months
clinical periodontal parameters
大体时间：3 months
Gingival Thickness (GT): Thickness of peri-implant gingiva. Unit: mm. Time Frame: 3 months post-operatively.
3 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。

赞助

Mansoura University

调查人员

  • 首席研究员：mohamad sa haichal, bachelor、Faculty of Dentistry Mansoura University

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 (实际的)

2025年10月1日

初级完成 (估计的)

2026年9月28日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年1月17日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月11日

研究记录更新

最后更新发布 (实际的)

2026年5月11日

上次提交的符合 QC 标准的更新

2026年5月5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

  • A0101025 OM

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

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