Clinical Wound Healing After Fully-impacted Lower Third Molar Surgery Using Two Different Type of Flap: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- wound healing day 14
研究概览
简要总结
The dehiscence distal to the second molar after lower third molar extraction is very common because the access flap for surgical extraction cannot be repositioned on a portion of healthy bone to guarantee suture support. The healing process is therefore delayed and the possible accumulation of food and debris is often responsible for bad smell and pain with the consequent occurrence of an overlapping infection.
The main aim of the study is to evaluate whether healing is significantly different using two different flaps for surgical access. Clinical assessment and a quality of life questionnaire are used for the evaluation.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •fully-impacted lower third molar
- •patients aged between 18 and 35
排除标准
- •patients undergoing drug treatment for systemic diseases that can influenced the healing process,
- •pregnant women,
- •smoking habits
- •patients with disabilities
- •all interventions in which intraoperative accidents involving the soft tissues occurred (laceration of the mucosa / flap).
结局指标
主要结局
wound healing day 14
时间窗: 14 days after surgery
a clinical chart is complete to evaluate if in the group of lower third molar extracted with a bayonet flap the proportion of healing without dehiscence (good healing index) is significant greater than in the group of third molar extracted with an envelope flap.
wound healing day 2
时间窗: 2 days after surgery
a clinical chart is complete to evaluate if in the group of lower third molar extracted with a bayonet flap the proportion of healing without dehiscence (good healing index) is significant greater than in the group of third molar extracted with an envelope flap.
wound healing day 7
时间窗: 7 days after surgery, at suture removal
a clinical chart is complete to evaluate if in the group of lower third molar extracted with a bayonet flap the proportion of healing without dehiscence (good healing index) is significant greater than in the group of third molar extracted with an envelope flap.
次要结局
- quality of life day 2(2 days after surgery)
- quality of life day 14(14 days after surgery)
- Pell & Gregory class(intra-operative)
- tooth position(pre-operative)
- quality of life day 5(5 days after surgery)
- quality of life day 7(7 days after surgery, at suture removal)
- dehiscence(14 days after extraction)
- pre-operative symptoms(pre-operative)
- interincisive height(pre-operative)
- type of impaction(pre-operative)
- Partial Plaque Score(pre-operative)
- Full Mouth Plaque Score(pre-operative)
- depth of impaction(pre-operative)
- description root morphology(pre-operative)
- description of relationship with the second molar(pre-operative)
- duration of surgery(intra-operative)
- description number of roots(pre-operative)
- quantity of keratinized gingiva(pre-operative)
- maximum diameter of the bone cavity(intra-operative)
- probing depth distal to the second molar(pre-operative)
- position of the gingiva with respect to the CEJ (cemento-enamel junction) of the second molar(pre-operative)
- maximum depth of the bone cavity(intra-operative)
- position of the gingiva(intra-operative)
研究者
Pippi Roberto
MDDS, associate Professor
University of Roma La Sapienza