Radiographic And Histomorphometric Assessment Following Alveolar Ridge Preservation Using Chitosan Gel Versus Normal Socket Healing In Posterior Maxillary and Mandibular Region A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in radiographic horizontal ridge width at 3 mm below the most coronal aspect of the crest
研究概览
简要总结
After tooth extraction, the alveolar bone, which supports the teeth, undergoes a natural resorption process. This bone loss can be significant, especially in the first few months post-extraction, leading to a reduction in both bone height and width. This resorption can compromise the structural foundation required for future dental restorations, such as implants, bridges, or dentures.
Socket preservation technique has been proposed since years as a technique to preserve alveolar bone following extraction and has proved excellent clinical efficacy over years.
Several materials have been proposed for alveolar ridge preservation, such as autografts, allografts, xenografts, and alloplasts, each with its own set of advantages and limitations. However, these materials may have limitations, including potential immunogenic responses and variable integration.
Thus, there is always a need to explore and validate new materials to mitigate these issues. This study aims to tests one of these new materials named chitosan gel to investigate whether the application of this chitosan gel following posterior mandibular tooth extraction would better preserve alveolar ridge dimensions and improve bone quality compared to normal socket healing or not ?.
详细描述
Tooth extraction often leads to significant alveolar ridge resorption, which can complicate future dental implant placement and prosthetic rehabilitation . Socket preservation techniques aim to mitigate these dimensional changes, and various materials have been investigated for this purpose .
Chitosan, a natural biopolymer derived from chitin, has shown promising results in tissue engineering and regenerative medicine due to its biocompatibility, biodegradability, and antimicrobial properties.
Previous studies have demonstrated that chitosan can enhance bone regeneration and wound healing, making it a potential candidate for socket preservation. However, there is limited clinical evidence comparing chitosan to natural socket healing in the context of alveolar ridge preservation.
This trial aims to fill this gap by conducting a detailed histomorphometric analysis and assessing alveolar ridge dimensional changes post-extraction. Histomorphometric analysis will provide insights into the quality and quantity of new bone and soft tissue formation, offering a microscopic evaluation of the regenerative process. By comparing these parameters between chitosan-treated sockets and those that heal naturally, the study seeks to determine if chitosan can better preserve ridge dimensions and improve tissue regeneration quality.
The findings from this trial could have significant clinical implications, potentially leading to improved socket preservation techniques and materials. Enhanced preservation of the alveolar ridge could reduce the need for additional grafting procedures, facilitate easier and more predictable implant placement, and ultimately improve patient outcomes.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient having at least one hopeless tooth in posterior maxillary and mandibular area
- •18 years old or older.
- •Motivated patients agree to sign the written informed consent and complete the follow up period
- •Medically fit patients.
- •No acute infections, pus formation, socket and bony discharges.
- •Compliant the patient to ensure the follow up
排除标准
- •Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of >6 mg/ml of nicotine).
- •Pregnant females.
- •Presence of active infection or severe inflammation in the intervention zone.
- •Relevant medical history that contraindicates implant surgery.
- •Immunosuppression (eg. Hiv, solid-organ transplants).
- •Head and neck-irradiated patients in the past 5 years.
- •Regular intake of bisphosphonates, anticoagulants, or anti-inflammatories.
- •Chronic drug abuse or alcoholic habits.
- •Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score >15%) and lack of motivation.
- •Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%).
- •Active periodontal disease.
- •Patients with significant comorbidity such as recent heart attack or coagulation disorder.
- •Patients with a history of allergies.
- •Mentally and physically handicapped patients.
研究组 & 干预措施
Chitogel
Chitogel (chitosan gel) for socket preservation
干预措施: Chitosan gel Sigma-Aldrich® in socket preservation (Procedure)
Gelfoam
Absorbable gelatin sponge (gelfoam) for socket preservation
干预措施: Gelfoam® absorbable gelatin sponge in socket preservation post extraction (Procedure)
结局指标
主要结局
Change in radiographic horizontal ridge width at 3 mm below the most coronal aspect of the crest
时间窗: 6 months postoperatively
CBCT scans will be performed at baseline and 6 months postoperatively. Measurements will be taken at both time points using identical reference points and lines. To establish a reference, the most apical point of the extraction socket will be identified on the baseline image, and two reference lines will be drawn. The vertical reference line will be placed at the midpoint of the extraction socket, intersecting the apical reference point. Additionally, a horizontal reference line will be drawn perpendicular to the vertical line, passing through the apical reference point. The horizontal ridge width will be measured at three specific levels: 1 mm, 3 mm, and 5 mm below the most coronal aspect of the crest. These measurements will be denoted as HW-1, HW-3, and HW-5, respectively.
次要结局
- Change in radiographic horizontal ridge width at 1mm and 5mm below the most coronal aspect of the crest.(6 months postoperatively)
- Change in radiographic buccal and palatal ridge height(at baseline, at 6 months post operatively)
- Percentage of new vital bone formation(6 months postoperatively)
- Wound healing and pain(at baseline,1 day, 5 days, 10 days, 6 months postoperative)
研究者
Ghazalh Motte Abdalkareem Abdalqawe
Radiographic And Histomorphometric Assessment Following Alveolar Ridge Preservation Using Chitosan Gel Versus Normal Socket Healing In Posterior Maxillary and Mandibular Region. A Randomized Controlled Clinical Trial
Cairo University