Usefulness of Amelogenins in the Treatment of Periodontal Defects on the Distal Surface of the Lower Second Molar After Adjacent Third Molar Extraction: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 主要终点
- CAL (Clinical attachment level) pre operative
研究概览
简要总结
Background: Prevention of periodontal defects after the extraction of lower third molars remains a challenge. Various methods have been proposed in the literature, but there are no studies which evaluated the effectiveness of amelogenins.
Methods: A single-blind split-mouth randomized controlled clinical trial (RCT) was performed on 5 patients to verify if amelogenins had some benefits in improving lower second molar periodontal healing after adjacent third molar extraction. A PPD ≥ 8 mm associated with a radiographic bone defect of at least 5 mm were the main inclusion criteria.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 27 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged < 27, for which the extraction of both lower third molars was indicated
- •Bilateral total (bone or osteo-mucosal) third molar impaction
- •Bilateral bone defect ≥ 5mm distal to the lower second molars, evaluated on pre- operative periapical radiographs performed with Rinn's film holders
- •PPD ≥ 8mm distal to the second lower molars, in at least one of the following probing sites: buccal, disto-buccal, disto-central, disto-lingual
- •Intra-operative integrity of both third molar buccal and lingual alveolar cortices
排除标准
- •Smoking habit
- •Systemic disorders with serious immunologic impairment
- •Taking cortisone or other drugs that might interfere with healing process
- •Allergy to penicillins
- •Previous periodontal treatment
- •Less than 2 mm of adherent gingiva at second molar level
- •Second molars with a prosthetic crown
- •Previous endodontic treatment of second molars
- •Furcation involvement of the second molars
研究组 & 干预措施
amelogenins group
The study involved enrolling 5 periodontitis free patients, to which the extraction of both lower third molars was prescribed. A bone defect at the distal surface of the second molar ≥ 5 mm, had to be present on the intraoral periapical radiography, bilaterally. Amelogenins effect was evaluated by applying them only in the test site and comparing healing results with those obtained on the contra-lateral site
干预措施: Amelogenin (Drug)
placebo group
The study involved enrolling 5 periodontitis free patients, to which the extraction of both lower third molars was prescribed. A bone defect at the distal surface of the second molar ≥ 5 mm, had to be present on the intraoral periapical radiography, bilaterally. In this group (control site) the conventional treatment was performed, and healing was ensured only by the simple blood clot
干预措施: Placebos (Drug)
结局指标
主要结局
CAL (Clinical attachment level) pre operative
时间窗: baseline, pre-surgery
CAL (Clinical attachment level) post operative
时间窗: 7 days after surgery
CAL (Clinical attachment level) 3 months
时间窗: 3 months after surgery.
CAL (Clinical attachment level) 12 months
时间窗: 12 months after surgery.
PPD (Periodontal probing dept) pre operative
时间窗: baseline, pre-surgery
PPD (Periodontal probing dept) post operative
时间窗: 7 days after surgery
PPD (Periodontal probing dept) 3 months
时间窗: 3 months after surgery.
PPD (Periodontal probing dept) 12 months
时间窗: 12 months after surgery.
REC (recession) pre operative
时间窗: baseline, pre-surgery
REC (recession) post operative
时间窗: 7 days after surgery
REC (recession) 3 months
时间窗: 3 months after surgery.
REC (recession) 12 months
时间窗: 12 months after surgery.
Radiographic bone Level pre operative
时间窗: An endoral x-ray was taken baseline, pre-surgery
Radiographic bone Level post operative
时间窗: An endoral x-ray was taken 7 days after surgery
Radiographic bone Level 3 months
时间窗: An endoral x-ray was taken 3 months after surgery.
Radiographic bone Level 12 months
时间窗: An endoral x-ray was taken 12 months after surgery.
次要结局
- Adverse Events pre operative(pre-operative)
- Adverse Events post operative(7 days after surgery)
- Adverse Events 3 months(3 months after surgery.)
- Adverse Events 12 months(12 months after surgery.)
研究者
Pippi Roberto
MDDS, associate Professor
University of Roma La Sapienza