Evaluation of healing of extraction socket, bone morphologic changes, primary implant stability and patient reported outcome measures with the use of E-Bone (naturally sourced nano-hydroxyapatite graft): A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Assessment of the bone quality and bone dimensions and assessment of primary stability of implant
研究概览
简要总结
This Study is a single centered, randomized control trial.
Aim:The aim of this study is to evaluate the bone changes, primary stability and patient reported outcome measures on placing egg shell derived nanohydroxyapatite bone grafting material into an extraction socket followed by implant placement.
Objectives:
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To evaluate the bone changes (radiographic and histomorphic) on placement of the nano-hydroxyapatite egg shell derived biomaterial in the extraction socket followed by implant placement.
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To evaluate the primary stability of the implants placed in the implant site formed on placement of the nano-hydroxyapatite egg shell derived biomaterial using a Osstell ISQ RFA device.
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To evaluate the patient reported outcome measures for the surgical procedures involving socket preservation and implant placement using the nano-hydroxyapatite egg shell derived biomaterial.
Material and Method:
Patients shall be selected from the OPD of Department of Prosthodontics and Oral and Maxillofacial Surgery. After the extraction of the indicated tooth, the patients shall be randomly assigned into two groups: to the Test group 1 (Control group) the Test group 2 (Interventional Group). For the TG2, the sockets shall be filled with the egg shell derived nano-hydroxyapatite biomaterial up to the original level of the alveolar ridge; For the TG1, pressure pack is applied and allowed to be filled by clotting that will be allowed to form naturally. Nano-hydroxyapatite Graft Material used for grafting are synthesized from natural calcium precursors obtained from chicken eggshell waste and produced using a rapid microwave processing technique. Extraction of the tooth or tooth root will be performed atraumatically under local anesthesia. If necessary, curettage shall be performed and irrigation will be done with Betadine and saline. After hemostasis, nHA grafting will be performed to the crestal level in the TG2 group and buccal advancement flap will be used for primary closure of the site using 4.0 non absorbable polyamide sutures.
Postoperative care for both the groups shall include continued 500 mg amoxicillin+ 125mg Clavulenic Acid every 12 hr for 5 days and Aceclofenac 100mg +Serratiopeptidase 15mg + Paracetamol 325 mg twice daily for 5 days, as well as use of the mouthwash with 0.12% chlorhexidine two times a day for 14 days. After sevendays, the sutures shall be removed. Patients shall be instructed to use ice bags on the surgical region within 48 h after surgeries and to eat only soft and cold food during this period. Four months after tooth extraction surgery, implant planning shall be done. The following shall be evaluated for each patient in both the groups: radiographic bone density, bone height and width. The data from the CBCT shall be further be used for implant planning and assessment. Assessment of the bone quality and bone dimensions shall be done by a single blinded assessor who shall not be involved in the graft placement. Surgical placement of the implant shall be done by one trained operator who shall be blinded for the groups. Primary stability of the implant placed shall be recorded for each patient by the same blinded operator by using Osstell ISQ RFA device.
Referance articles
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SureshKumar G, Thamizhavel A, Girija EK. Microwave conversion of eggshells into flower-like hydroxyapatite nanostructure for biomedical applications. Mater Lett 2012;76:198-200.
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Kattimani VS, Lingamaneni KP, Kreedapathi GE, Kattappagari KK. Socket preservation using eggshellderived nanohydroxyapatite with platelet-rich fibrin as a barrier membrane: a new technique. J Korean Assoc Oral Maxillofac Surg 2019;45:332-342. https://doi.org/10.5125/jkaoms.2019.45.6.332
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Kattimani VS, Prathigudupu RS, et al. Role of Synthetic Hydroxyapatite—In Socket Preservation: A Systematic Review and Meta-analysis. J Contemp Dent Pract 2019;20(8):987–993.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who had teeth with indication for extraction, with extensive cavities, root fracture or vertical periodontal defects of maxillary or mandibular first and second molars.
- •Patients in whom single or multiple teeth were indicated for extraction for reasons other than chronic periodontitis.
- •Patients with age 18-45 years with good oral hygiene and teeth in need of extraction in regions where the use of a temporary prosthesis or mucosal support was not necessary shall be recruited.
排除标准
- •Smokers, ASA III and IV, pregnant women, patients with Stage III or IV periodontal disease will be excluded from the study.
- •Patients with gross tooth mobility due to complete bone loss (more than 3/4 of root length).
- •Patients with any abnormal findings during clinical or radiological examination.
- •Example: Patients with ankylosed roots or other root morphological alterations that may complicate the procedure.
- •Patients undergoing Immunosuppressive conditions such as AIDS, Cancer or Radiation therapies.
- •Subjects with positive COVID results.
结局指标
主要结局
Assessment of the bone quality and bone dimensions and assessment of primary stability of implant
时间窗: 4 months after tooth extraction surgery
次要结局
- Recommendation of patient(At time of implant placement (4 months after tooth extraction surgery))
- Number of consultation(At time of implant placement (4 months after tooth extraction surgery))
- Pain(At time of implant placement (4 months after tooth extraction surgery))
- Histomorphic Evaluation(At time of implant placement (4 months after tooth extraction surgery))
- Treatment difficulty(At time of implant placement (4 months after tooth extraction surgery))