Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in minor postoperative complications (trismus)
研究概览
简要总结
In the everyday clinical practice the incidence of minor complications is approximately 15-20% of the total number of third molar removals. Alveolitis (dry socket syndrome) may arise in 30-40% of the surgical tooth removals. Several preventive approaches are known, such as the use of iodoform gauze, zink-oxide eugenol paste, platelet rich fibrin (PRF), different medicine containing pastes, like antibiotics containing, non-steroid pain killer containing, steroid containing, or the application of chlorhexidine gel and solutions. In the case of a manifest alveolitis these methods can be used as well. The aims of this research are: i) to identify the important pathogens which play role in the development of alveolitis (microbiological methods), ii) to analyze the in vitro effectivity of the different antiseptic materials in case of infections (inhibitory zones) iii) to compare the effectivity of different alveolitis preventive methods in a prospective clinical study, iv) to compare the different treatment options in alveolitis in a prospective clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pell-Gregory II/B impaction
- •mesioangular impactions
- •tooth sectioning is not necessary for removal
- •without local infection of third molar
排除标准
- •no general diseases or following treatments (DM, steroids, bleeding risk, chemotherapy, radiotherapy, bisphosphonates, immunosuppressive conditions)
研究组 & 干预措施
Primary wound closure
Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.
干预措施: Wound closure using sutures (Other)
Iodoform and wound closure
Patients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture (Surgilon 3-0 non-absorbable) placements for a week.
干预措施: Iodoform (Drug)
Iodoform and wound closure
Patients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture (Surgilon 3-0 non-absorbable) placements for a week.
干预措施: Wound closure using sutures (Other)
Chlorhexidine and wound closure
Extraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements.
干预措施: Wound closure using sutures (Other)
Chlorhexidine and wound closure
Extraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements.
干预措施: Chlorhexidine (Drug)
结局指标
主要结局
Change in minor postoperative complications (trismus)
时间窗: day of surgery, 3rd, 7th postoperative days
Measuring postoperative trismus (maximal mouth opening - inter-incisal distance in millimeters).
Change in minor postoperative complications (oedema)
时间窗: day of surgery, 3rd, 7th postoperative days
measuring postoperative oedema (flexible ruler- lateral canthus-mandibular angle distance in millimeters and tragus-labial commissure distance in millimeters).
Change in necessity of postoperatively taken analgesics
时间窗: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Registering number of daily repeats of taken analgesics.
Change in minor postoperative complications (pain)
时间窗: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Measuring level of pain in Visual Analog Scale (minimum score is 0 which represents no pain, maximum score is 10 which shows the worst pain) postoperatively
次要结局
未报告次要终点
研究者
Balazs Soos
DMD, Assistant Professor
University of Pecs
