A prospective, randomized controlled clinical trial comparing the wound protection ability of Absorbable Collagen Wound Dressings and its impact on palatal wound healing and post-operative pain.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Absorbable
研究概览
简要总结
During the last decades, the field of periodontology has been vastly influenced by the esthetic trend with various surgical procedures proposed in the literature for treating gingival recession (GR). In 1984, Hall concluded that the combination of predisposing factors such as inadequate attached gingiva, high frenum attachment, mal-positioned teeth and osseous dehiscence and precipitating factors such as vigorous tooth brushing, laceration, recurrent inflammation and other iatrogenic factors contributes to the pathogenesis of gingival recession. Evidence shows that with minimal amount of keratinized and attached gingiva, periodontal health can be maintained. However, due to the unpredictability of patient habits or other iatrogenic factors, periodontal plastic surgery may still be required for natural teeth or dental implants in some circumstances when risk factors are present. Soft Tissue Grafting in Periodontology Free gingival grafts (FGG) and De-epithelialized gingival graft (DGG) have been found to be the most commonly grafts used in periodontal plastic surgeries to correct mucogingival defects in morphology, position and/or amount of soft tissue and underlying bone support for teeth and dental implants. The free gingival graft was first described by Bjorn in 1963. Sullivan and Atkins in 1968 then explored the feasibility and healing of the free gingival graft. The predictability and long-term stability of the surgical outcome for free gingival graft has been well established. Similarly coronally advanced flap (CAF) + SCTG is considered the ‘gold standard’ for the treatment of Miller Class I and II GR. however, these surgical procedures require autogenous graft harvesting. Harvesting the donor graft from the palate can cause longer chair time, higher possibility of healing morbidity, and intra- and/or postoperative discomfort, which can lower patient acceptance. Postoperative management of donor site The surgical technique of free gingival grafting requires harvesting of soft tissue from the palatal donor site and transplantation to the intraoral recipient site. Post-surgical complications and atypical healing processes have been described in the literature. Postoperative pain, swelling, excessive hemorrhage, infection and graft shrinkage are the most common complications, additionally, bone exposure, recurrent herpetic lesions, mucoceles and arteriovenous shunts have been reported. In order to reduce the morbidity events associated with mucogingival surgery, there are several ways to manage the donor site after soft tissue harvesting. Use of analgesics has become a standard of care after surgery, and adjuncts such as surgical dressings, collagen matrices, different suturing methods and plastic palatal protective stents can also be used to improve patient comfort and reduce bleeding of donor sites. In a split mouth prospective randomized clinical trial, Alec Yen et al. in 2007 showed that platelet concentration may accelerate wound healing and regeneration of soft tissue, however, there were no statistical differences in terms of the occurrences of complications or post-operative pain. Hemostatic agents Various hemostatic agents have been employed to manage post-operative bleeding at the donor site. Currently the interest is focused upon absorbable synthetic collagen, absorbable gelatin sponge, and oxidized regenerated cellulose. Side effects of application the used of hemostatic agents include foreign body reactions or retarded healing of the wound. It has been demonstrated that Absorbable Collagen sponge wound dressing is bactericidal against broad range of gram-positive and gram- negative organisms including antibiotic resistant bacteria (MRSA, VRE, PRSP and MRSE) When applied in periodontal surgery, Pollack and Bouwsma found that the bactericidal activity is non specific and effective against several periodontal pathogens. Seven to ten days after application, the material degraded and released carboxylic acid moieties, which lower the pH. The low pH of the carboxylic acid helped local hemostatic action and then activated the platelets to form a temporary plug. The low pH of carboxylic acid groups also created an acidic environment in which most of the bacteria were unable to survive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •(1) Patients with age more than 18 years (2) Patients who are systemically healthy with no systemic disease contraindicated to dental surgery.
- •(3) Patients with palatal tissue thickness less than 2 mm evaluated with a University of North Carolina (UNC) periodontal probe for bone sounding, placed perpendicular to the hard palate before surgery.
- •(4) Patient having at least one site of natural dentition or dental implant that needed to be treated by free gingival graft surgery or de-epithelialized gingival graft surgery for one of the following indications including progressive recession, planned prosthodontics, mucogingival deformity, or lack of keratinized gingiva.
排除标准
- •Patients who smoke.
- •Patients with coagulation disorders (history of hemophilia, von Willebrand disease), or currently subject to anticoagulant therapy.
- •Patients with altered healing patterns (i.e., type 2 diabetes mellitus).
结局指标
主要结局
To evaluate the effect of Absorbable
时间窗: 1 week, 2week and 1 month
Collagen Wound Dressing with sutures on palatal wound healing after harvesting free gingival grafts (FGG) or De
时间窗: 1 week, 2week and 1 month
epithelialized gingival graft (DGG) utilizing a healing index.
时间窗: 1 week, 2week and 1 month
次要结局
- To evaluate the effect of Absorbable(Collagen Wound Dressing with sutures on)
研究者
Dr Nihal Devkar
Sinhgad Dental College and Hospital, Pune
