Evaluation of Chlorhexidine Plus Hyaluronic Acid Mouthwash in Surgical Wound Healing Following Third Molar Surgery (CLOR_4)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Wound Healing Index (WHI) (Wachtel classification)
研究概览
简要总结
Evaluation of the response of gingival tissues to the use of mouthwash with chlorhexidine and chlorhexidine + hyaluronic acid in terms of healing of the surgical wound following third molar surgery.
详细描述
Wound healing following third molar surgery will be evaluated at the level of the flap incision. Surgical interventions will be performed following a standardized protocol by a single operator.
After surgery, patients will be randomly assigned to study groups corresponding to mouth rinse prescription. The mouth rinse will be assigned by an experimenter not involved in the following steps of the study, in order to maintain the examiner blind. The patient will receive a non-labelled mouth rinse to avoid biases both of the examiner and the patient. The patient will also be given a diary for the registration of the number of rinses per day, to be returned to the examiner at T14. The mouth rinse protocol assigned to each study participant includes a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.
The patients will be allocated in one of the three distinct study groups as it follows:
Group A: administration of 0.2% chlorhexidine + anti-discoloration system + hyaluronic acid mouth rinse (test group 1) Group B: administration of 0.2% chlorhexidine + anti-discoloration system mouth rinse (test group 2).
Group C: administration of placebo mouth rinse (control group)
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
- 是
入选标准
- •males or females of age range between 18 and 70 years,
- •good health status,
- •indication to perform third molar surgery,
- •patients willing to give informed consent,
- •compliance to the study follow-up,
排除标准
- •pregnancy or breast-feeding,
- •indication to antibiotic therapy prior to surgical treatment,
- •chronic infections,
- •systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases),
- •previous therapy with the mouth rinses employed in the present study, and
- •smoking habit (>20 cigarettes per day, and/or pipe or cigar smoking).
研究组 & 干预措施
Test group 1
Surgery will be performed following a standardized protocol by a single operator. The procedure consists in the performance of a primary full-thickness flap incision, and of a secondary releasing vertical incision of maximum 3 mm limited to keratinized gingiva. At the end of the surgical procedure, soft tissues will be repositioned by means of a suture involving only the primary incision, while it will not be performed on the releasing incision.
Device: 0.2% chlorhexidine + anti-discoloration system + hyaluronic acid mouth rinse The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.
干预措施: Parallel Assignment (Device)
Test group 2
Surgery will be performed following a standardized protocol by a single operator. The procedure consists in the performance of a primary full-thickness flap incision, and of a secondary releasing vertical incision of maximum 3 mm limited to keratinized gingiva. At the end of the surgical procedure, soft tissues will be repositioned by means of a suture involving only the primary incision, while it will not be performed on the releasing incision.
Device: 0.2% chlorhexidine + anti-discoloration system mouth rinse The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.
干预措施: Parallel Assignment (Device)
Control Group
Surgery will be performed following a standardized protocol by a single operator. The procedure consists in the performance of a primary full-thickness flap incision, and of a secondary releasing vertical incision of maximum 3 mm limited to keratinized gingiva. At the end of the surgical procedure, soft tissues will be repositioned by means of a suture involving only the primary incision, while it will not be performed on the releasing incision.
Device: placebo mouth rinse The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.
干预措施: Parallel Assignment (Device)
结局指标
主要结局
Wound Healing Index (WHI) (Wachtel classification)
时间窗: Measured at day 3, day 7, and day 14
Changes in WHI, measured orally through clinical examination on all the incisions, assigning a score from 1 to 5. Score 1: complete wound healing: absence of fibrin line in the interproximal area Score 2: complete wound healing: presence of a thin fibrin line in the interproximal area Score 3: complete wound healing: presence of fibrin clot in the interproximal area Score 4: incomplete wound healing: presence of partial necrosis of the interproximal area Score 5: incomplete wound healing: total necrosis of the interproximal area
次要结局
未报告次要终点
研究者
Filippo Graziani, DDS MClinDent PhD
DDS MClinDent PhD
University of Pisa