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临床试验/NCT05990049
NCT05990049招募中3 期

Impact of Hyaluronic Acid on Free Gingival Graft Healing and Palatal Donor Site Wound Healing

University of Zagreb1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
40
试验地点
1
主要终点
Shrinkage of the graft

研究概览

简要总结

This study aims to evaluate the impact of locally applied hyaluronic acid on free gingival graft wound bed healing and palatal donor site wound healing.

Forty subjects will be randomly divided in two separate groups. Test group will be treated with hyaluronic acid during the procedure and the control group without.

Periodontal parameters and other clinical measurements will be taken on baseline, 7 days postoperative, 14 days postoperative, 1 month, 3 months and 6 months postoperative.

详细描述

Free gingival graft is common, simple and predictable surgical procedure. Patients who have keratinized tissue width less than 2 mm will undergo the surgery after passing the inclusion criteria together with initial periodontal therapy. Total number of 40 patients will be divided in two separate groups; test group (hyaluronic acid) and control group based on random choice.The randomization will be examiner blind.

After the application of local anaesthesia, surgical procedure will be done in the same groups equally. In the recipient site, an horizontal incision will be performed on the mucogingival junction or 1-2 mm above it to include the free marginal gingiva. Partial thickness flap will be dissected in order to ensure the vascularisation of the graft. The size of the incision and graft will depend on the keratinized tissue width of the teeth area.

The graft will be taken from the donor site on the anterior palate in the area of premolars and molars. The graft will be measured with periodontal probe (UNC-15) in 3 dimensions over the flat surface and after the harvesting will be put in glass with saline. Donor site will be sutured using fibrin sponge and non-resorbable sutures. The size of recipient site and graft will depend on number of teeth with keratinized tissue width less than 2 mm.

The graft will be positioned on the recipient site and stabilised using non-resorbable suture performing single sutures and a sling suture around the tooth. The group of patients who will receive the hyaluronic acid will be treated on donor and recipient site before the suturing, applied once on the wound bed.

Postoperatively, patients will be instructed to rinse with 0.12% chlorhexidine digluconate twice a day. The patients will be asked to keep a diary for 7 days about pain sensations using VAS scale for donor and recipient site. An analgetic treatment will be prescribed if needed.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • no systemic disease
  • non-smokers
  • at least one tooth with keratinized tissue width less than 2 mm

排除标准

  • heavy smokers
  • younger than 18years old
  • using drugs
  • allergy on anesthesia
  • using drugs or alcohol
  • undergoing chemotherapy
  • undergoing radiotherapy

研究组 & 干预措施

Hyaluronic acid

Active Comparator

During the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing.

干预措施: Hyadent BG (Drug)

结局指标

主要结局

Shrinkage of the graft

时间窗: baseline to 6 months postoperatively

changes of the graft in apico - coronal and mesio-distal dimensions

Keratinized tissue gain

时间窗: baseline to 6 months postoperatively

changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction

次要结局

  • Dimensional changes in gingival recessions(baseline to 6 months postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Badovinac

assistant professor

University of Zagreb

研究点 (1)

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