Analysis of Early Healing After the Use of Two Types of Sutures in Periodontal Surgery. A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Periodontal healing index (PQI) (Landry et al., 1988)
研究概览
简要总结
The main objective is to analyze post-surgical periodontal healing after conventional periodontal surgery where an absorbable suture coated with clorhexidine (Novosyn Clorhexidine) versus conventional sutures without chlorhexidine (Novosyn) will be used a pilot randomized clinical study has been designed.
Up to authors´ knowledge until now there are no studies to evaluate periodontal healing after periodontal surgery in combination with this kind of sutures.
详细描述
A total of 60 patients will be included, where the unit of study will be each stitch, among the patients attending the Dental Clinic Service of the University of the Basque Country (UPV/EHU) who require surgical periodontal treatment.
The patients will be randomly divided into two groups: the control group using a conventional suture (n=30), and the test group using a suture coated with chlorhexidine diacetate (n=30).
Suture in the control group: absorbable suture of polyglactin 910 coated with polyglactin 370 + calcium stearate without chlorhexidine (NOVOSYN) Suture in the test group: absorbable suture of polyglactin 910 coated with polyglactin 370 + calcium stearate and chlorhexidine diacetate (NOVOSYN CHLORHEXIDINE) The primary variable in this study is post-surgical healing in both groups, which will be assessed using the healing index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant: Initially, the subject will not know which suture he/she has received, full information regarding the suture used, as well as the results obtained in his/her case, will be given at the last visit of the study.
Observer: (R.E. Another periodontist, external to the intervention, will be in charge of recording the clinical parameters.) Analyst: (X. M. The statistician does not know to which treatment each variable corresponds.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ≥ 18 years-old
- •Patients who have completed the basic periodontal phase and require surgical periodontal treatment for periodontal disease control.
- •Plaque index (O'Leary et al.,1972) ≤20%.
- •Bleeding index (Ainamo & Bay,1975) ≤20%.
排除标准
- •Patients with systemic conditions contraindicating surgery
- •Patients with allergy to chlorhexidine and/or o-cymen-5-ol
- •Patients allergic to non-steroidal anti-inflammatory drugs (NSAIDs)
- •Pregnant or breastfeeding women
- •Patients with periodontal defects requiring regenerative surgery or mucogingival surgery/periodontal plastic therapy
- •Patients who have taken antibiotics in the last 3months
结局指标
主要结局
Periodontal healing index (PQI) (Landry et al., 1988)
时间窗: at 7 days, 14 days, 1 month and 2 months after surgery
This periodontal healing index was described by Landy et al. in 1988. The index consists of the assessment of 5 clinical parameters (tissue color, bleeding on palpation, presence of granulation tissue, presence of suppuration, and healing of the surgical margin). The index will be from 1 to 5, where point 1 was defined as "healing way scarce" and point 5 such as "excellent healing" (Landry RG, Turnbull RS, Howley T. Effectiveness of benzydamine HCL in the treatment of periodontal post-surgical patients. Res Clin Forums. 1988; 10:105-118)
次要结局
- Post-surgical complications (PSCs)(The day of the removal of sutures)
- Cytological-histological analysis(The day of the removal of sutures)
- Pain on suture removal(The day of the removal of sutures)
- Pre-surgical pain(The day of the surgical intervention)
- Post-surgical pain(At 7 days after the surgery)
- Surgery location information (location of suture, surgery time, surgeon´s experience)(The day of the surgery)
- Presence of Visible plaque on the suture(The day of the removal of sutures)
- Suture looseness(The day of the removal of sutures)
- Clinical level of central sensitization of the subject (Subclinical, Medium, Moderate, Severe and Extreme)(Prior to surgery)
- Achievement of primary closure after suturing (in the surgical act).(The day of the surgery)
研究者
Ana María García de la Fuente
Professor
University of the Basque Country (UPV/EHU)