A Randomized Controlled Clinical Trial on the Effectiveness of Three Different Mouthrinses, Adjunct to Periodontal Surgery, in Dental Plaque Control and Early Wound Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Assessment of Periodontal Soft Tissue Healing Progress Between Baseline (Immediately After Surgery), 7 and 14 Days Postoperatively (Evaluated by Early Wound Healing Index - EHI)
研究概览
简要总结
Aim: This study compared the effectiveness of three different mouthrinses (alcohol and non-alcohol chlorhexidine, alkyl dimethyl glycine / alkyl dimethyl amine oxide - C31G) in plaque control and early wound healing, postoperatively.
Materials and Methods: In this, randomized, double-blind, controlled clinical trial 42 patients were allocated to three groups assigned to two weeks rinsing after periodontal surgery with C31G (group A), alcohol-free chlorhexidine 0.12% (group B) or alcohol-based chlorhexidine 0.12% (group C). At weeks 1 and 2, plaque and early wound healing indices were recorded. At day 14, total bacterial counts were estimated utilizing real - time qPCR. Statistics included linear and generalized linear mixed models.
详细描述
Materials and Methods
Patients' enrollment and all clinical procedures were conducted at the Department of Periodontology, School of Dentistry, National and Kapodistrian University of Athens, Greece.
Clinical Procedures:
All surgical interventions were conducted by first and third year postgraduate residents. Supragingival debridement and polishing of the operated area was performed immediately before surgery. In cases of residual periodontal pocket elimination / reduction surgeries, intrasulcular incisions followed by papilla preservation incisions at interdental areas were applied. In crown lengthening cases, resective gingival incisions were applied in presence of sufficient width of keratinized tissues (≥ 3mm). Following flap elevation, root surfaces were thoroughly debrided with instruments and ultrasonic devices. Ostectomy / osteoplasty with carbide burs was applied, as deemed appropriate. Buccal and palatal / lingual flaps were fully adapted to each other and sutured together with monofilament slowly resorbable suture. Periodontal dressings were not used. No systemic antibiotics were prescribed. Ibuprofen 400mg, three times daily for 4 days, was suggested immediately after surgical intervention. Smokers were advised to cease smoking for the first postsurgical week. Sutures were removed at 7th postoperative day. During that period no accidental loss of sutures was recorded.
Randomization and allocation concealment:
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)
入排标准
- 年龄范围
- 34 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in need of periodontal pocket elimination / reduction or surgical crown lengthening with or without osseous surgery in one of the following regions: #13-15 or #23-25 or #33-35 or #43-
- •In cases of pocket elimination / reduction, at least two teeth with ≥ 1 residual periodontal pocket ≥ 5mm and bleeding on probing was mandatory.
- •Width of keratinized tissues ≥ 2mm around teeth included in the operated area.
- •Cause - related therapy should be completed ≥ 6 weeks before surgical procedure.
- •Plaque Index (O'Leary et al. 1972) < 25% and Gingival Bleeding Index (Ainamo and Bay 1975) < 25% in whole dentition should be achieved.
排除标准
- •Uncontrolled diabetes mellitus type 1 or 2 (HbA1c > 7%).
- •Smoking > 20 cigarettes/day.
- •Systemic antimicrobial therapy the last 3 months before the surgical procedure.
- •Steroidal or/and non - steroidal anti-inflammatory drug therapy the last 15 days.
- •Immunodeficiency or immunosuppressive drug therapy.
- •History or current chemotherapy or/and radiation therapy.
- •Oral bisphosphonates intake > 3 years or intravenous bisphosphonates therapy.
- •Pregnancy or/and breastfeeding.
- •Need for osseous graft and/or membrane or any other regenerative material application.
- •Furcation involvement of first maxillary premolars and furcation involvement > class I at the mesial entrance of first maxillary molars.
- •Missing teeth, fixed partial dentures, removable dentures or orthodontic brackets in the candidate regions for periodontal surgery.
研究组 & 干预措施
C31G (Group A)
C31G
干预措施: C31G (Drug)
Alcohol-free Chlorhexidine (Group B)
Alcohol-free Chlorhexidine Gluconate 0.12%
干预措施: Alcohol-free Chlorhexidine Gluconate 0.12% (Drug)
Alcohol-based Chlorhexidine (Group C)
Alcohol-based Chlorhexidine Gluconate 0.12%
干预措施: Alcohol-based Chlorhexidine Gluconate 0.12% (Drug)
结局指标
主要结局
Assessment of Periodontal Soft Tissue Healing Progress Between Baseline (Immediately After Surgery), 7 and 14 Days Postoperatively (Evaluated by Early Wound Healing Index - EHI)
时间窗: Early Wound Healing Index was recorded at the 7th and 14th postsurgical day
EHI measurements range between 1-5: 1. = Complete flap closure-no fibrin line in interproximal area. 2. = Complete flap closure-fibrin line in interproximal area. 3. = Complete flap closure-fibrin clot in the interproximal area. 4. = Incomplete flap closure-partial necrosis of interproximal tissue. 5. = Incomplete flap closure-complete necrosis of the interproximal tissue.
次要结局
- Plaque Index (PI)(PI was recorded 14 days postoperatively)
- Plaque Area Index (PA%)(PA% was recorded at the 7th and 14th postoperative day)
研究者
Anastasios M. Gkatzonis, MSc
DDS, MSc
National and Kapodistrian University of Athens