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临床试验/NCT07665281
NCT07665281已完成不适用

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

Al-Mustansiriyah University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年12月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2

研究概览

简要总结

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 prevent bias during the evaluation of soft tissue width and crestal bone measurements.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Group 1: Dental Implants + Hyaluronic Acid

Experimental

Patients receive dental implants combined with hyaluronic acid gel applied at the implant site.

干预措施: Dental Implants with Hyaluronic Acid (Procedure)

Group 2: Dental Implants + Hyaluronic Acid + Bone Graft

Experimental

Patients receive dental implants combined with hyaluronic acid gel and particulate bone graft applied at the implant site.

干预措施: Dental Implants with Hyaluronic Acid and Particulate Bone Graft (Procedure)

Group 3: Control Group: Dental Implants Alone

Active Comparator

Patients receive standard dental implants placement alone without any adjunctive materials.

干预措施: Standard Dental Implants Placement only (Procedure)

结局指标

主要结局

未指定

次要结局

  • Postoperative Pain Scores(Three times daily (morning, afternoon, and evening) for the first 7 days postoperatively)

研究者

发起方
Al-Mustansiriyah University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Monya Noori Hassan

Principal Investigator

Al-Mustansiriyah University

研究点 (2)

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