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临床试验/NCT03567148
NCT03567148已完成不适用

Evaluation of The Effectiveness of Different Methods for Healing a Palatal Donor Site After Harvesting a Free Gingival Graft

Gazi University0 个研究点目标入组 90 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
主要终点
VAS questionnaire regarding to postoperative pain

研究概览

简要总结

Postoperative complications associated with free gingival graft (FGG) procedures are prolonged bleeding from the donor site, postoperative pain and delayed wound healing which increases the patients' morbidity. Hence, the aim of this study is to assess the effectiveness of different treatment modalities on palatal wound healing and patient's morbidity after FGG. Ninety patients requiring FGG were randomly will be assigned into six groups: group 1: Platelet rich fibrin (PRF) membrane, group 2: Essix retainer, group 3: topical ozone therapy, group 4: low-level laser therapy (LLLT), group 5: collagen fleece and group 6: untreated control group. Epithelization will be evaluated by means of bubble formation; sensitivity, edema, pain, changes in eating habits and burning sensation will be assessed by using visual analog scale (VAS) and also the presence of discomfort and bleeding will be evaluated in the postoperative first week and at 14 days, 1 and 3 months postoperatively.

详细描述

Inadequate attached gingiva is one of the major mucogingival problems for many individuals. However, the width of the keratinized tissue required to prevent periodontal disease remains unclear. Recently, a consensus report highlighted that if an individual's plaque control is suboptimal, a minimum of 2 mm of keratinized tissue and 1 mm of attached gingiva is needed.

Palatal keratinized mucosa is the most favorable donor region for a free gingival graft (FGG) due to its anatomic properties such as being histologically identical to keratinized attached mucosa of alveolar ridge and its ideal tissue thickness. The FGG surgical wound heals within 2-4 weeks, and prolonged bleeding, pain, and delayed wound healing of either the donor or recipient sites, which increases the patient's risk of morbidity, are the most common postoperative complications following surgery. Although homeostatic agents, mechanical barriers, and bioactive materials have been found to be effective in preventing these complications, the most ideal treatment has not yet been determined.

Platelet-rich fibrin (PRF), a platelet concentrate, is a safe and cost-effectiveness procedure that does not require biochemical blood handling. PRF has been used in many fields as an autologous biomaterial with a great healing potential for regenerating soft tissue and bones without inflammatory reactions, and it may be used to promote hemostasis and wound healing due to the presence of many growth factors. Recent studies have concluded that using PRF membranes after harvesting FGG enhances wound healing, reduces a patient's discomfort, and decreases need to change eating habits; thus, it reduces patient morbidity.

An Essix® retainer (Clear Advantage Series, Ortho Technology, Florida, USA) is a thermoplastic material used for stabilization after orthodontic treatment. It has been reported that gingival wounds that heal by secondary intention should be sheltered during the period of epithelization to protect against topical irritants, trauma, acidic or highly seasoned foods, and toothbrush abrasion.

It has been suggested that hemostatic agents provide faster and continuous hemostasis and make a positive contribution to early soft tissue healing. Application of hemostatic agents to the palatal donor sites has been found to be highly beneficial for achieving hemostasis in comparison to pressure only. Collagen fleece is a hemostatic agent that is made from the natural collagen of porcine dermis. The structure of the collagen promotes the formation and stabilization of blood clots during the initial wound healing phase. Recently, collagen-based materials have been used to improve early wound healing with an open healing design in the palatal area.

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 (Investigator)

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
是

入选标准

  • •age >18,
  • •systemically healthy,
  • •non-smoker,
  • •full-mouth plaque and bleeding scores <20%,
  • •isolated gingival recession defects on the mandibular and maxillary anterior teeth with insufficient keratinized gingiva,

排除标准

  • •history of mucogingival surgery on the palatal area
  • •pregnancy
  • •systemic antibiotics taken for at least six months before the study
  • •having systemic diseases that could compromise wound healing

研究组 & 干预措施

PRF group

Active Comparator

Four layers of PRF membranes were placed in the palatal wound and sutured with 5/0 resorbable sutures

干预措施: PRF (Procedure)

Essix retainer group

Active Comparator

An impression of palatal region was taken and the Essix retainer was prepared before the patients underwent surgery.

干预措施: Essix retainer (Procedure)

LLLT group

Active Comparator

Irradiation was performed at the same points described above using a diode laser (λ=970±15 nm, 14-W source power) (SIROLaser Xtend; Sirona Dental Systems GmbH, Bensheim, Germany) that continuously emitted a wavelength with 320µm fiberoptic; the power was 2W and the tissue dose was 35 J/cm2. Total irradiation time was 30 seconds. The applications were performed immediately after surgery, and on the 1st, 3rd and 7th, days following the operation.

干预措施: LLLT (Procedure)

Collagen fleece group

Active Comparator

Collagen fleece (BEGO Collagen Fleece, Bremen, Germany) was sutured with 5/0 resorbable sutures (Pegesorb, Istanbul, Turkey) on the open wound with the aid of vertical mattress sutures.

干预措施: Collagen fleece (Procedure)

Control group

No Intervention

Palatal wounds were left for spontaneous healing

Ozone therapy group

Active Comparator

Ozone was applied to the donor sites at five different points (four corner-points and a center point) at a fixed concentration of 2100 p.p.m. through a connected hand-piece, using a sterile, specially-formed perio-tip with 80% oxygen for 30 seconds. The applications were performed immediately after surgery and on the 1st, 3rd, and 7th days following the operation.

干预措施: Ozone therapy (Procedure)

结局指标

主要结局

VAS questionnaire regarding to postoperative pain

时间窗: 30th days postoperatively

The VAS was divided into 10 segments, and the patients were asked to rank their pain level using a scoring system ranging from 0 to 10

次要结局

  • VAS questionnaire regarding to postoperative sensitivity(30th days postoperatively)
  • VAS questionnaire regarding to burning sensation(30th days postoperatively)
  • hydrogen peroxide test(30th days postoperatively)
  • VAS questionnaire regarding to changes in eating habits(30th days postoperatively)

研究者

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

Sıla Çağrı İşler

Principal Investigator

Gazi University

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