Efficacy of Manual Versus Rotary Degranulation Techniques on Clinical and Radiographic Outcomes of Alveolar Ridge Preservation: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Operative time (seconds)
研究概览
简要总结
After a tooth is taken out, the empty socket needs to heal. Sometimes unhealthy soft tissue (called granulation tissue) is left behind and can slow down healing. This study compares two ways to clean the socket:
- Manual method: a hand instrument (curette)
- Rotary method: a small rotating dental bur
Both methods are standard in dental practice. The study will see which method is faster, causes less pain, and leads to better bone healing. After cleaning, all patients will receive a routine bone graft to protect the jawbone for a possible future dental implant.
The study will measure:
- How long (in seconds) it takes to clean the socket
- A harmless blue stain (Toluidine Blue) was used during cleaning to show any unhealthy tissue left behind, and cleaning continued until no stain remained; the stain showed when to stop rather than being measured on its own
- Changes in the bone at 3 and 6 months, measured by a special three-dimensional X-ray (cone-beam computed tomography, CBCT)
- Pain and swelling reported by patients in the first week after the procedure
- Any side effects or healing problems
Each extraction site is randomly assigned to one of the two cleaning methods (like flipping a coin), so a patient having two teeth treated may receive a different method at each. The surgeon knows which method is used, but the person analyzing the X-rays does not, to keep the results fair.
The study included 50 adult patients and 60 extraction sites. Some patients had two teeth treated, at separate appointments. It is being conducted at the College of Dentistry, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
详细描述
Tooth extraction is one of the most common procedures in dental practice, initiating a complex healing process within the socket. A critical step for uneventful healing is the complete removal of chronic granulation tissue, which is often present because of pre-existing periapical or periodontal pathology. Retained granulation tissue can impede bone regeneration and contribute to postoperative complications.
1.1 Study Design: A prospective, single-center, parallel-group randomized controlled trial with 1:1 allocation, conducted and reported in accordance with the CONSORT 2025 statement.
This study introduces an objective endpoint to this comparison by utilizing Toluidine Blue (TB), a vital stain that selectively binds to acidic tissue components like DNA and RNA, which are abundant in dysplastic and highly cellular tissues like granulation tissue. By applying TB to the socket immediately after extraction and continuing debridement until no residual stain remains, this study replaces the surgeon's subjective assessment of a clean socket with a visual endpoint, alongside cone-beam computed tomography (CBCT) ridge dimension changes.
Furthermore, the rationale for thorough degranulation extends beyond facilitating uneventful healing and is a critical determinant for the success of subsequent restorative procedures, particularly alveolar ridge preservation (ARP) and dental implant placement. Retained chronic granulation tissue can act as a physical and biological barrier, impeding the migration and proliferation of osteogenic cells and the integration of bone graft materials. This compromised graft incorporation can lead to suboptimal bone quality and volume, ultimately undermining the primary goal of ARP to minimize post-extraction ridge atrophy. Moreover, the presence of inflamed, non-mineralized tissue at the future implant site has been linked to higher failure rates, as it prevents the direct bone-to-implant contact osseointegration essential for long-term stability. Therefore, establishing a clean, well-prepared bony socket is not merely a procedural step, but a fundamental prerequisite to creating a predictable environment for successful bone grafting and, ultimately, the placement of a functional dental implant. While ARP studies focus on grafting materials and membranes, little attention has been given to the effect of degranulation technique itself.
Rationale:
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)
盲法说明
All cone-beam computed tomographic measurements contributing to the analysis are performed by one examiner who is blinded to allocation and who did not perform the surgical procedures. A second examiner, also blinded to allocation and not involved in the surgical procedures, independently measures a predefined subset of scans for reliability assessment only. Patients were not informed of their allocation, but complete patient blinding was not achievable because the rotary handpiece is audible and produces vibration that the curette does not.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be recruited from those attending the outpatient clinics of the College of Dentistry.
- •Adults aged 18-65 years of American Society of Anesthesiologists (ASA) physical status I, presenting with a tooth indicated for extraction due to chronic periapical pathology (e.g., periapical granuloma or cystic lesion) confirmed clinically and radiographically.
- •All cases must be verified with a cone-beam computed tomography (CBCT) scan demonstrating periapical pathology with intact socket walls and sufficient residual alveolar bone to allow for ridge preservation. A 10 x 10 cm volume covering both jaws is required, because the vertical reference landmarks for the radiographic outcome are the inferior border of the mandible and the floor of the maxillary sinus or nasal cavity.
- •Only teeth with single or multi-rooted lesions indicated for atraumatic extraction without excessive bone removal will be considered.
- •Participants must also be capable of providing informed consent, demonstrate adequate oral hygiene, and be willing to return for scheduled follow-up visits.
排除标准
- •Acute odontogenic infection at the extraction site.
- •Thin buccal bone (< 1mm on CBCT).
- •Severe periodontal breakdown with more than 50% bone loss.
- •Grade III mobility.
- •Root morphology that limits instrument accessibility.
- •Any systemic condition placing the patient above ASA I.
- •Pregnant or lactating women.
- •Medications known to affect bone metabolism such as long-term corticosteroids or bisphosphonates.
- •Self-reported or documented allergy to penicillin or amoxicillin.
- •Poor oral hygiene, inability to maintain adequate postoperative care, or unwillingness to attend scheduled follow-up visits.
研究组 & 干预措施
Manual Curettage
Granulation tissue removed with a #85 Lucas surgical curette 2.5mm. After debridement, alveolar ridge preservation with allograft and collagen membrane.
干预措施: Manual Curettage (Procedure)
Rotary Degranulation
Granulation tissue removed with a 2.5 mm super-coarse diamond degranulation bur at 1,000 RPM at the bur (1:1 contra-angle handpiece). After debridement, alveolar ridge preservation with allograft and collagen membrane.
干预措施: Rotary Degranulation (Procedure)
结局指标
主要结局
Operative time (seconds)
时间窗: During the degranulation procedure (Day 0)
Time from instrument engagement (rotary bur or manual curette) until the surgeon declares the socket clinically stain-free and free of any soft tissue, confirmed by Toluidine Blue staining. Measured by the second assistant using a digital stopwatch (HS-3V-1R, Casio Computer Co.,Tokyo, Japan) and recorded to the nearest second.
次要结局
- Toluidine blue stain-free socket rate(Immediately after debridement (Day 0))
- Cone-beam computed tomographic change in alveolar ridge dimensions(3 and 6 months post-extraction)
- Postoperative complications(Up to 6 months post-extraction)
- Patient-reported pain and swelling(First 7 postoperative days)
- Intraoperative complications(During the procedure (Day 0))
研究者
YASSER MOHAMMED BIN KHAMES
Periodontics Fellowship Resident
Imam Abdulrahman Bin Faisal University