跳至主要内容
临床试验/NCT07318298
NCT07318298招募中不适用

Effect of Injectable Hyaluronic Acid (HYADENT BG (HA)) on Bone Healing in Extraction Sockets

Jordan University of Science and Technology1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Postoperative Pain Intensity

研究概览

简要总结

Complications such as postoperative pain and delayed socket healing are relatively common following surgical extraction of mandibular third molars. Various biomaterials have been investigated to enhance wound healing and reduce postoperative morbidity. Hyaluronic acid (HA) has demonstrated anti-inflammatory and regenerative properties that may improve both soft and hard tissue healing.

The aim of this study is to evaluate the effect of topical hyaluronic acid on postoperative pain and alveolar socket bone healing following surgical extraction of mandibular third molars. A prospective, randomized, controlled clinical trial with a split-mouth design will be conducted. Twenty patients requiring bilateral mandibular third molar surgical extraction will be enrolled. In each patient, one extraction socket will receive hyaluronic acid combined with a collagen sponge, while the contralateral socket will receive a collagen sponge alone, according to random allocation. Postoperative pain will be assessed using a visual analogue scale, and socket healing will be evaluated radiographically and histologically.

详细描述

This study is designed as a prospective, randomized, controlled clinical trial with a split-mouth design to assess the effect of topical hyaluronic acid on postoperative pain and alveolar socket bone healing following surgical extraction of mandibular third molars. The study will be conducted at the Oral and Maxillofacial Surgery and Preventive Dentistry clinics, Faculty of Dentistry, Jordan University of Science and Technology, Irbid, Jordan.

A total of 20 patients requiring bilateral surgical extraction of mandibular third molars will be enrolled. All participants will receive verbal and written information regarding the study procedures, and written informed consent will be obtained prior to participation. Randomization will be performed using a closed-envelope method. In each patient, one extraction site will be randomly allocated to receive hyaluronic acid gel combined with a collagen sponge (test site), while the contralateral site will receive a collagen sponge alone (control site).

The hyaluronic acid used in this study is a low-molecular weight sodium hyaluronate gel (Hyadent®, BioScience GmbH, Ransbach-Baumbach, Germany), supplied in sterile 1 mL syringes with blunt angulated cannulas. Each syringe contains sodium hyaluronate (14.0 mg), sodium chloride (6.9 mg), and water for injection. The formulation has modified viscosity and a short resorption time, allowing rapid absorption by the surrounding tissues.

All surgical procedures will be performed by a single experienced oral surgeon under standardized conditions. Preoperative evaluation includes medical and dental history, clinical examination, and panoramic radiography. Local anesthesia will be administered using an inferior alveolar nerve block with buccal infiltration of 2% lidocaine with 1:100,000 epinephrine. A standardized mucoperiosteal envelope flap will be raised for all procedures. Bone removal and tooth sectioning will be carried out when necessary using a low-speed handpiece under copious sterile saline irrigation.

After tooth removal, hyaluronic acid gel will be placed into the extraction socket at the test site and covered with a collagen sponge. Control sites will receive a collagen sponge alone. Primary closure will be achieved using 3-0 silk sutures. All patients will receive standardized postoperative instructions and medications. Sutures will be removed on postoperative day seven.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female participants aged 18 to 35 years
  • Presence of bilateral impacted mandibular third molars classified as Pell and Gregory Class II, Position B
  • Classified as American Society of Anesthesiologists (ASA) Physical Status I
  • Absence of active local infection at the surgical site (e.g., no swelling, trismus, hyperthermia)
  • Ability to maintain adequate oral hygiene
  • Ability to understand and provide written informed consent
  • Ability to read and understand Arabic or English
  • Willingness to comply with study procedures and follow-up visits

排除标准

  • History of systemic diseases such as diabetes mellitus, hypertension, gastric ulcer, or other significant medical conditions
  • Presence of severe or chronic illness requiring frequent hospitalization
  • Pregnant or breastfeeding individuals
  • History of cognitive or motor impairment that may interfere with study participation
  • Use of anti-inflammatory or analgesic medications within two weeks before surgery
  • Known allergy or hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Current smoker
  • Use of anticoagulant therapy
  • Any condition that, in the investigator's judgment, may interfere with healing or study outcomes

研究组 & 干预措施

placebo extraction side

Placebo Comparator

Surgical extraction of wisdom tooth with placebo administration inside the extraction site using collagen sponge

干预措施: Surgical extraction of wisdom teeth (Procedure)

placebo extraction side

Placebo Comparator

Surgical extraction of wisdom tooth with placebo administration inside the extraction site using collagen sponge

干预措施: bone biobsy (Procedure)

experimental extraction side

Experimental

Surgical extraction of wisdom tooth with placebo administration inside the extraction site using hyaluronic acid gel

干预措施: bone biobsy (Procedure)

experimental extraction side

Experimental

Surgical extraction of wisdom tooth with placebo administration inside the extraction site using hyaluronic acid gel

干预措施: Surgical extraction of wisdom teeth (Procedure)

结局指标

主要结局

Postoperative Pain Intensity

时间窗: 12 hours (postoperative day 1), postoperative day 3, and postoperative day 7. Units of measure is VAS score (1-10).

Postoperative pain intensity will be assessed using a visual analogue scale (VAS) ranging from 1 (no pain) to 10 (worst pain imaginable). Participants will record pain scores at standardized time points following mandibular third molar extraction.

Alveolar Socket Bone Healing

时间窗: 6 weeks after tooth extraction. units of measure is percentage of woven bone area (%)

Alveolar socket bone healing will be evaluated histologically by quantifying the percentage of woven bone formation within the extraction socket. Core biopsies will be obtained six weeks post-extraction and analyzed using digital histomorphometry. The percentage of woven bone area within predefined regions of interest will be calculated using ImageJ software.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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