Soft and Hard Tissue Healing Following Alveolar Ridge Preservation of Mandibular Third Molar Extraction Socket Filled With Auto Tooth Bone Graft or Alloplastic Graft
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Periodontal assessment on lower second molar
研究概览
简要总结
This study compared two bone graft materials: 1. Auto Tooth Bone (ATB) (made from the patient's own extracted tooth) and 2. EthOss® a synthetic 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 ATB and the other receiving EthOss®. Over a 24-week follow-up period, researchers tracked patient clinically on their comfort, gum healing, and new bone growth using X-rays. The study found that both materials performed similarly and showing no significant differences in pain, swelling, complications, or gum healing. While there was a statistical difference in final bone depth. Both grafts successfully stimulated new bone growth, proving that ATB and EthOss® are equally safe, reliable, and effective options for supporting recovery after wisdom tooth surgery.
详细描述
Surgical removal of impacted mandibular third molars may lead to complications that include periodontal defects at the second molar. Alveolar socket preservation with graft material can reduce this complication. This study aims to assess the soft and hard tissue healing of the surgical sites following the removal of impacted mandibular third molars with alveolar socket preservation using auto tooth bone graft (ATB) or EthOss® alloplastic graft and comparing for any difference between both grafts. This is a split-mouth, double blinded, randomized controlled study. Participants underwent surgical removal of bilateral impacted mandibular third molars with either socket filled with ATB or EthOss® alloplastic graft. The participants were reviewed 1 week and 4 weeks post-operative for signs of graft reaction/rejection. Periodontal assessments were performed at post-operative week 12 and 24 to assess the soft tissue healing. Radiological assessment was done at post-operative week 24 to assess bone depth. There was no significant difference between ATB and EthOss® graft in the healing of the soft tissue adjacent to the sockets, post-operative sequelae (pain, trismus and facial swelling) or post-operative complications. However, a statistically significant difference was observed in bone depth within both groups. The healing outcomes and bone quality achieved with ATB and EthOss® are comparable. Both materials have demonstrated effective osteoconductive properties, making them reliable materials for bone regeneration. This equivalency in clinical performance supports the use of either material as viable alternatives for bone regeneration procedures with predictable results.
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)
盲法说明
Patient and surgeons are masking from the usage of different bone graft materials
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 M2 adjacent to the M3 to be extracted.
- •Patient aged 18 to 35 years old.
- •Patient with periodontal status of:
- •Basic Periodontal Score (BPE) 2 at lower right and lower left sextants.
- •Full mouth plaque score <30%.
排除标准
- •Impacted M3 associated in the following conditions:
- •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 of unerupted/impacted M
- •Patient's age <18 years old or > 35 years old
- •M2 with periapical inflammation, periodontitis, distal caries or delayed or non-responsive pulp sensibility test to exclude tooth with perio-endo lesion.
- •Pregnant woman.
- •Patient on oral contraceptives.
- •Current or previous bisphosphonate therapy or history of radiotherapy to the jaws.
- •Active smoker.
研究组 & 干预措施
Auto Tooth Graft
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. Auto Tooth Graft and Intervention 2. Ethoss alloplast material simultaneously on opposite sides of the lower third molar
干预措施: auto tooth graft material (Combination Product)
Ethoss
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. Auto Tooth Graft and Intervention 2. Ethoss alloplast material simultaneously on opposite sides of the lower third molar
干预措施: auto tooth graft material (Combination Product)
结局指标
主要结局
Periodontal assessment on lower second molar
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) 2. modified bleeding score (Score 0: No bleeding observed after probing. Score 1: Bleeding is present.) 3. Periodontal Pocketing Depth (PPD) (measurement in milimeter, 1-3mm indicate healthy sulcus while \>5mm indicate periodontal disesase) 4. gingival recession- measurement in mm for gingival margin below the cementoenamel junction. The higher the score, the worse of the periodontal health condition
Periodontal health assessment on lower second molar
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. 2. Modified Bleeding Score (Score 0: No bleeding observed after probing. Score 1: Bleeding is present.)-- the lower the score, the better the periodontal health. 3. 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. 4. Gingival Recession- measurement in mm for gingival margin below the cementoenamel junction. - the lower the score, the better the periodontal health.
次要结局
- Bone gain(radiograph taken prior to surgery and 24 weeks after surgery)
研究者
Tan Chuey Chuan
Associate Professor Dr
University of Malaya