Clinical and Radiographic Evaluation of Non-Incised Papilla Surgical Approach Versus Modified Minimally Invasive Surgical Technique in Treatment of Intra-osseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Assessment of CAL gain
研究概览
简要总结
The aim: Clinical and Radiographic Evaluation for intra-osseous defects in stage III periodontitis using NIPSA versus M-MIST Steps in short Pre-surgical therapy
• Before surgical intervention, each patient will be given careful instructions on proper oral hygiene measures.
Surgical Procedures:
- Group B (Control): Patients will receive Modified Minimally Invasive Surgical technique (M-MIST) Group A (Test): Patients will receive Non-Incised Papilla Surgical Approach (NIPSA) Postoperative medication
- Administration of amoxicillin (500 mg tabs) T.I.D for 7 days and Metronidazole (500 mg tabs) T.I.D for 7 days
- Rinsing with Chlorhexidine 0.12% (B.I.D for 14 days).
- Ibuprofen 600 mg tabs once every 8h could be administrated in case of unbearable pain
- Follow up period: after 8 weeks/ after surgery by 1 week- 1 month- 3 months- 6 months- 1 year
详细描述
P: Population: Stage III periodontitis presenting intraosseous defects I: Intervention: Non-Incised Papilla Surgical Approach (NIPSA) C: Control: Modified Minimally Invasive Surgical Technique (M-MIST) O: Outcome measurements T: 1- year S: Randomized clinical trial
Surgical Procedures:
The operator will anesthetize the surgical sites with 4% ARTINIBSA containing Articaine hydrochloride Epinephrine (adrenaline) 1: 100.000 injection for both groups. For patients that recieved (NIPSA) as reported by (Moreno Rodríguez and Caffesse 2017).
- After locally anesthetizing the area an apical horizontal incision on the buccal mucosa, as far as possible from the interdental papillae and marginal KT will be performed. Soft tissue will be reflected apico-coronally by a full-thickness flap showing the granulation tissue filling the bony defect after exposing the coronal limit of the intra-bony component of the defect, while the marginal tissue will be kept unaltered.
- Horizontal mattress sutures with single interrupted sutures will be placed as the second line of closure.
while patients that received (M-MIST) reported by (Banthia et al. 2016a)
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
- None
盲法说明
Single blinded:
- Blinding of the participants is not applicable.
- Blinding of the operator is not applicable.
- Outcome assessor (primary and secondary outcomes) & biostatistician will be blinded.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stage III periodontitis patient having at least one tooth with Two walls or combined 2- to 3-walls intraosseous defects ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
- •Defect not extended to a root furcation area.
- •Vital teeth
- •Non-smokers.
- •No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
- •No periodontal therapy carried out in the past 6 months.
- •Able to sign an informed consent form.
- •Patients age between 20 and 60 years old.
- •Patients who are cooperative, motivated, and hygiene conscious.
- •Able to come for the follow up appointment's needed.
- •Systemically free according to Modified Cornell Medical Index health questionnaire (Kark et al., 1964).
排除标准
- •Pregnancy or breast feeding.
- •The presence of an orthodontic appliance.
- •Teeth mobility greater than grade I.
结局指标
主要结局
Assessment of CAL gain
时间窗: baseline/ after 6 months & 1 year post-surgical
Clinical attachment Level gain (CAL) by UNC Periodontal probe (mm)
次要结局
- radiographic bone fill.(1 year)
- Assessment of PD reduction(1 year)
- gingival recession(1 year)
研究者
Marwa EL-Desouky Helal
Lecturer assistant
Cairo University