A Comparative Study on the Application of Alloplastic Bone Graft With Polycaprolactone (PCL) Membrane and ECM-Collagen Membrane on Secondary Socket Healing in Third Molar Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Periodontal health assessment on lower second molar (4)
研究概览
简要总结
This study compared two membrane materials: 1. polycaprolactone (PCL) and 2. Extracellular matrix collagen membrane (ECM) as alternative. This is to see how well they prevent bone and gum damage after lower wisdom tooth removal. In this split-mouth trial, participants had both lower wisdom teeth removed, with one socket receiving PCL membrane and the other receiving ECM membrane after socket filled with EthOss (an alloplastic bone graft). Over a 24-week follow-up period, researchers tracked patient clinically on their comfort, gum healing, and new bone growth using X-rays.
详细描述
Surgical removal of impacted mandibular third molars (M3) often associated with post-operative morbidities such as pain, facial swelling, limited mouth opening and injuries to the inferior alveolar nerve or lingual nerve. In addition, it can result in compromised periodontal health of the adjacent second molar (M2) and reduced alveolar bone height at the M3 region. The defect can be restored using bone substitutes with membrane. This study aims to assess wound healing of the surgical sites of third molar surgery with application of alloplastic bone graft with PCL membrane and ECM-collagen membrane. This is a split-mouth, double blinded, randomized controlled study. Participants underwent surgical removal of bilateral impacted mandibular third molars with either socket covered with PCL membrane and ECM-collagen membrane after filled up EthOss® alloplastic graft. The participants will be reviewed at post-operative 1 week (T1), 1 month (T2), 3 months (T3) and 6 months (T4) to monitor for signs of graft reaction/rejection. Periodontal assessments were performed at these four visits to assess the soft tissue healing. Radiological assessment (intraoral periapical x-ray) will be done at preoperative and post-operative week 24 to assess bone depth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patient who requires surgical removal of bilateral impacted M
- •Patient with impacted bilateral M3 which are sound.
- •Impacted bilateral M3 classified as Class I or II with Level A or B according to Pell and Gregory's classification.
- •Presence of disease-free mandibular second molar (M2) adjacent to the M3 to be extracted
- •Patient aged 18 to 35 years old who are medically fit
排除标准
- •Impacted M3 associated with:
- •Fracture of angle of mandible.
- •Radiological evidence of cyst or tumour.
- •Incomplete root formation.
- •Acute pulpitis or severe pericoronitis that is not under controlled.
- •Gross dental caries.
- •Retained roots of mandibular third molar with history of removal or coronectomy of unerupted/impacted M
- •Patients with periodontal disease
- •Patients with absence of lower second molars.
- •Medically compromised patients
- •Pregnant women.
- •Patient on oral contraceptives.
- •Current or previous bisphosphonate therapy or history of radiotherapy to the jaws.
- •Active smokers
研究组 & 干预措施
PCL membrane
This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2. ECM collagen membrane after socket filled with Ethoss alloplast material simultaneously on either sides of the lower third molar
干预措施: Extracellular matrix collagen (ECM) membrane (Combination Product)
ECM collagen membrane
This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. PCL membrane and Intervention 2. ECM collagen membrane after socket filled with Ethoss alloplast material simultaneously on either sides of the lower third molar
干预措施: polycarprolactone membrane (PCL membrane) (Combination Product)
结局指标
主要结局
Periodontal health assessment on lower second molar (4)
时间窗: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Gingival Recession- measurement in mm for gingival margin below the cementoenamel junction. - the lower the score, the better the periodontal health.
Periodontal health assessment on lower second molar (5)
时间窗: baseline on day of surgery, 12 weeks and 24 weeks after surgery
The healing index of Landry (Grade 1 poor to Grade 5 excellent)
Periodontal health assessment on lower second molar (1)
时间窗: baseline on day of surgery, 12 weeks and 24 weeks after surgery
1\. Modified Plaque Score (from Score 0: No plaque present. Score 1: No visible plaque, but a periodontal probe skimmed across the tooth surface reveals soft plaque biofilm on the tip. Score 2: Visible plaque that can be easily seen with the naked eye without using a probe., modified bleeding score and gingival recession, periodontal pocketing depth)-- the lower the score, the better the periodontal health.
Periodontal health assessment on lower second molar (2)
时间窗: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Modified Bleeding Score (Score 0: No bleeding observed after probing. Score 1: Bleeding is present.)-- the lower the score, the better the periodontal health
Periodontal health assessment on lower second molar (3)
时间窗: baseline on day of surgery, 12 weeks and 24 weeks after surgery
Periodontal Pocketing Depth (PPD) (measurement in milimeter, 1-3mm indicate healthy sulcus while \>5mm indicate periodontal disesase)-- the lower the score, the better the periodontal health.
次要结局
- The width of keratinized tissue(baseline on day of surgery, 12 weeks and 24 weeks after surgery)
- Bone gain at distal of lower second molar(radiograph taken prior to surgery and 24 weeks after surgery)
研究者
Tan Chuey Chuan
Associate Professor Dr
University of Malaya