Comparison of Autogenous Dentin Graft With Albumin Platelet Rich Fibrin Versus Autogenous Dentin Graft With Platelet Rich Fibrin in Alveolar Socket Preservation: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Alveolar ridge width (buccolingual).
研究概览
简要总结
The study focuses on the impact of tooth loss on alveolar bone, which shrinks significantly within the first three months. To prevent this, strategies like alveolar ridge preservation are used.
Autogenous dentin, taken from the patient, supports healing and bone regrowth. Platelet-rich fibrin (PRF), made from the patient's blood, enhances healing and bone density by releasing growth factors.
A new technique combining L-PRF with albumin creates a stable healing membrane that provides a steady release of growth factors. Overall, these methods improve recovery after tooth extractions and prepare sites for future dental work.
详细描述
Study Design and Randomization:
- Patients classified randomly using computer-generated randomization.
- Performed by the supervisor.
- Three main study groups established.
- Decision for treatment group assignment based on randomized numbers in opaque sealed envelopes, picked by the supervisor.
Groups:
- Control Group:
- 20 sockets with empty sockets to allow spontaneous healing post-extraction.
- Study Group 1:
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
Blinding is achievable for the biostatistician also .
However, Care Provider cannot be blinded due to the fundamentally different surgical procedures in the three groups. It is not possible to blind the participants since those in the test groups will undergo a specific intervention that involves venous blood withdrawal for the preparation of PRF and ALB-PRF.
Concerning the blinding of participants, we will implement partial blinding, which will apply exclusively to the test groups (group 1 and 2) involved in a specific intervention that requires venous blood collection for the creation of PRF and ALB-PRF.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically free patients.
- •Adult patients above 18 Years to 60 Years.
- •Non-restorable tooth indicated for extraction.
- •Posterior mandibular teeth.
- •Inactive infection related to the tooth.
- •Cooperative patients.
排除标准
- •Presence of any systemic disease that could influence the outcome of the therapy.
- •Presence of any risk factor (smoker, pregnant and lactating patients).
- •Patients with bone diseases.
- •Patients with poor oral hygiene.
研究组 & 干预措施
empty socket
干预措施: empty socket (Other)
Autogenous Dentin Graft with Platelet Rich Fibrin
Autogenous Dentin Graft with Albumin Platelet Rich Fibrin
干预措施: Autogenous Dentin Graft with Albumin Platelet Rich Fibrin (Procedure)
结局指标
主要结局
Alveolar ridge width (buccolingual).
时间窗: at baseline immediately after extraction and after six months
Will be assessed via Cone-Beam Computed Tomography (CBCT) that Provides a radiographic assessment of the buccolingual width by measuring the distance between buccal and lingual bone walls.
Alveolar ridge height (apicocronal)
时间窗: at baseline immediately after extraction and after six months
Will be assessed via Cone-Beam Computed Tomography (CBCT) that Provides a radiographic assessment of the apicocronal height by measuring the ridge height from the top of the alveolar ridge to the upper border of the alveolar canal.
Bone density
时间窗: at baseline immediately after extraction and after six months
Will be assessed via Cone-Beam Computed Tomography (CBCT) The measurement helps in assessing the quality of bone directly through Hounsfield units (HU) (between D1 and D5; D1: \> 1250 HU, D2: 850 to 1250 HU, D3: 350 to 850 HU, D4: 150 to 350 HU, D5: \< 150 HU).
次要结局
- Patient satisfaction(at 24 hours, 3 days, 7 days,14 days postoperative and after six months)
- Keratinized tissue width(at baseline before extraction and after six months)
- Pain scores(at 24 hours, 3 days, 7 days and 14 days postoperative)
研究者
MUATH ATIF MOHAMEDAHMED HASSAN
Master student
Kafrelsheikh University