Evaluation of the Rinse With Chlorhexidine Plus Hyaluronic Acid Mouthwash in Periodontal Surgical Wound Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Pocket probing depth (PPD)
研究概览
简要总结
Evaluate the response of the gingival tissues to the use of mouthwash with chlorhexidine and chlorhexidine + hyaluronic acid in terms of healing of the periodontal surgical wound.
详细描述
Patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired: periodontal parameters of Probing Pocket Depth (PPD) and presence of recession of the gingival margin (Rec) will be recorded on six sites/tooth in the area selected for periodontal surgery by a single calibrated examiner using a University of North Carolina (UNC) 15-mm periodontal probe at a 0.3 N probing pressure. Surgery 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: no administration of mouth rinses after surgery (control group)
- Group B: administration of a hyaluronic and 0.2% chlorhexidine mouth rinse (test group 1)
- Group C: administration of chlorhexidine 0.2% mouth rinse (test group 2).
Post-treatment photographs of surgical incision will be taken immediately after periodontal surgery and at 3 (T3), 7 (T7), and 14 (T14) days post-op, in order to allow the evaluation of the degree of wound healing. The degree of surgical healing will be evaluated using the Periodontal Wound Healing Index (Wachtel classification) on all the incisions, and a score from 1 to 5 will be assigned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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
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 periodontal surgery,
- •patients willing to give informed consent,
- •compliance to the study follow-up,
- •plaque index (PI) score 0 and
- •bleeding on probing (BOP) <25%
排除标准
- •pregnancy or breast-feeding,
- •therapy with oral contraceptives,
- •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).
结局指标
主要结局
Pocket probing depth (PPD)
时间窗: Measured at Baseline and at day 3, day 7, and day 14
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
次要结局
- Recession of the gingival margin (REC)(Measured at Baseline and at day 3, day 7, and day 14)
- Bleeding on probing (BOP)(Measured at Baseline)
- Clinical attachment level (CAL)(Measured at Baseline and at day 3, day 7, and day 14)
- Plaque index (PI)(Measured at Baseline and at day 3, day 7, and day 14)
- Angulated bleeding index (AngBI)(Measured at day 3, day 7, and day 14)
- Periodontal Wound Healing Index (PWHI) (Wachtel classification)(Measured at day 3, day 7, and day 14)
- Post-surgical photographs(Taken at Baseline, day 3, day 7, and day 14)
研究者
Filippo Graziani, DDS MClinDent PhD
Full Professor of Periodontology
University of Pisa