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Impact of Hyaluronic Acid and Bone Graft on Peri-Implant Tissue

2026年7月5日更新者：Monya Noori Hassan、Al-Mustansiriyah University

Impact of Hyaluronic Acid and Bone Graft on PeriImplant Tissue Phenotype."A Randomized Controlled Trial"

This randomized controlled clinical trial aims to evaluate the effect of hyaluronic acid (HA) and particulate bone graft on the peri-implant tissue phenotype in patients receiving dental implants. Healthy adult participants requiring dental implant placement will be randomly allocated into one of three equal groups (12 implants per group): Group 1 will receive dental implants combined with hyaluronic acid gel (Gengigel); Group 2 will receive dental implants combined with both hyaluronic acid and particulate bone graft; and the control group will receive dental implants alone.

Clinical and radiographic assessments will be performed using a customized measurement stent to ensure standardized evaluations at baseline, immediately postoperatively, and at 8 and 16 weeks of follow-up. The primary and secondary outcomes include alterations in ridge width, keratinized tissue width/thickness, radiographic soft tissue height, and marginal bone height. The study aims to determine whether the adjunctive use of hyaluronic acid and bone grafts enhances the quality of the peri-implant soft and hard tissue phenotype.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

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

伊拉克
- Babylon
  - Hillah、Babylon、伊拉克
    - College of Dentistry, University of Babylon
  - Hillah、Babylon、伊拉克
    - Private specialized dental center

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

是的

描述

Inclusion Criteria:

Adults ≥ 18 years old.
Partially edentulous patients requiring dental implant placement.
Good oral hygiene (Calibrated Gingival Bleeding Index (GBI) < 10%, O'Leary ---Plaque Index (PI) < 10%).
Sufficient bone volume for implant placement.

Exclusion Criteria:

Systemic conditions affecting bone healing (e.g., uncontrolled diabetes).
Smoking > 10 cigarettes/day.
Medications affecting bone metabolism (e.g., bisphosphonates).
Active periodontal disease.
Pregnant or lactating women.

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：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Group 1: Dental Implants + Hyaluronic Acid Patients receive dental implants combined with hyaluronic acid gel applied at the implant site.	程序：Dental Implants with Hyaluronic Acid Surgical placement of dental implants, followed by the application of hyaluronic acid gel at the implant site, was performed to evaluate its impact on peri-implant tissue phenotype.
实验性的：Group 2: Dental Implants + Hyaluronic Acid + Bone Graft Patients receive dental implants combined with hyaluronic acid gel and particulate bone graft applied at the implant site.	程序：Dental Implants with Hyaluronic Acid and Particulate Bone Graft Surgical placement of dental implants, combined with the application of hyaluronic acid gel and particulate bone graft at the implant site, was performed to evaluate its impact on peri-implant tissue phenotype.
有源比较器：Group 3: Control Group: Dental Implants Alone Patients receive standard dental implants placement alone without any adjunctive materials.	程序：Standard Dental Implants Placement only Standard surgical placement of dental implants following conventional clinical protocols without the application of any adjunctive materials.

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
Ridge Width Changes (RW) 大体时间：Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks.	The changes in Ridge Width is measured at the reference points using a digital vernier caliper.	Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks.
Bone Width (BW) 大体时间：Baseline (preoperative), and 16 weeks postoperatively	Measured in millimeters by subtracting the buccal and lingual mucosal thickness from the ridge width.	Baseline (preoperative), and 16 weeks postoperatively
Change in width of keratinized tissue (KTW) 大体时间：Baseline (preoperative), 8 weeks, and 16 weeks	Measured in millimeters at the mid-buccal aspect of the implant site using an endodontic rotary file and digital vernier caliper.	Baseline (preoperative), 8 weeks, and 16 weeks
Keratinized Tissue Thickness (KTT) 大体时间：Baseline (preoperative), and 16 weeks postoperatively	Measured in millimeters at the buccal, crestal and lingual reference points using a periodontal probe and a digital vernier caliper.	Baseline (preoperative), and 16 weeks postoperatively
Radiographic Mucosal Thickness (RT) 大体时间：Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks	Measured in millimeters on periapical radiographs using digital software from the crestal bone level to the crest of crestal oral mucosa 5 mm away from the height distal surface of the adjacent tooth on the mesial side of the implant.	Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks
Crestal Bone Height (BH) 大体时间：Immediate postoperative, 8 weeks, and 16 weeks	Measured in millimeters on periapical radiographs using digital software from the second serration on the mesial side of the implant to the crest of the bone.	Immediate postoperative, 8 weeks, and 16 weeks

次要结果测量

结果测量	措施说明	大体时间
Plaque Index (PI) 大体时间：Baseline (preoperative), 8 weeks, and 16 weeks	O'Leary plaque index	Baseline (preoperative), 8 weeks, and 16 weeks
Gingival Index (GI) 大体时间：Baseline (preoperative), 8 weeks, and 16 weeks	Gingival Bleeding Index	Baseline (preoperative), 8 weeks, and 16 weeks
Postoperative Pain Scores 大体时间：Three times daily (morning, afternoon, and evening) for the first 7 days postoperatively	Patients received a standardized pain assessment chart for self-evaluation over seven consecutive postoperative days. This chart featured an 11-point (0-10) Numerical Rating Scale (NRS) integrated with the Wong-Baker Faces Pain Rating Scale and supplemented with descriptive pain expressions ranging from a minimum value of 0 (representing no pain) to a maximum value of 10 (representing the worst possible pain), where higher scores indicate a worse outcome (greater pain severity).	Three times daily (morning, afternoon, and evening) for the first 7 days postoperatively

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

Al-Mustansiriyah 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12月5日

初级完成 (实际的)

2026年7月2日

研究完成 (实际的)

2026年7月2日

研究注册日期

首次提交

2026年6月18日

首先提交符合 QC 标准的

2026年6月18日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年7月5日

最后验证

2026年7月1日

Impact of Hyaluronic Acid and Bone Graft on Peri-Implant Tissue