Clinical Effectiveness of Minimally Invasive Non-surgical Technique With or Without Extended Platelets Rich Fibrin in Intrabony Defects: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Probing Depth (PD)
研究概览
简要总结
This study evaluates a minimally invasive non-surgical technique (MINST) for treating periodontal intrabony defects, with or without the addition of Extended Platelet-Rich Fibrin (e-PRF). The goal is to determine which approach provides better bone regeneration and gum healing.
Study Procedures
Control Group:
Local anesthesia by infiltration at the treatment site
Instrumentation of the root surface up to the bottom of the periodontal pocket
Efforts are made to minimize trauma to soft tissues and interdental papilla using subpapillary access
Cleaning is performed using piezo-electric devices with delicate tips, avoiding aggressive root smoothing or gingival curettage
3-4× magnification loupes are used to improve precision
Intervention Group:
All the above procedures
Followed by injection of e-PRF, a preparation derived from the patient's own blood
Blood is collected in 4 mL tubes and centrifuged at 700 g for 8 minutes
The platelet-poor plasma is heated to create an albumin gel
The remaining buffy coat (rich in platelets and growth factors) is mixed with the cooled albumin gel to form Alb-PRF, which is applied to the defect
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
- Double (Participant, 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
- •Adults aged above 21 years. Clinical diagnosis of Stage III periodontitis. Presence of at least two isolated interproximal intrabony defects located in different quadrants.
- •Intrabony defect associated with a single-rooted tooth or mandibular molar without furcation involvement.
- •Probing depth (PD) ≥ 6 mm. Radiographic intrabony defect depth between 3 and 7 mm. Absence of periapical pathology at the study site. Absence of acute periodontal infection. Absence of subgingival restorations that could interfere with clinical measurements.
- •Absence of Grade II or Grade III tooth mobility. Ability and willingness to provide written informed consent.
排除标准
- •Pregnancy or lactation. Non-surgical periodontal therapy within the previous 6 months. Surgical periodontal therapy within the previous 12 months. History of radiotherapy to the head and neck region. Current smoking.
- •Eligibility note: Former smokers and never-smokers are eligible.
研究组 & 干预措施
MINST + Extended Platelet-Rich Fibrin (e-PRF)
Participants will receive modified minimally invasive non-surgical periodontal therapy (MINST) followed by the application of autologous extended platelet-rich fibrin (e-PRF) into the intrabony periodontal defect. MINST will be performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes while preserving root cementum and minimizing soft tissue trauma. The e-PRF will be prepared from the participant's peripheral blood by combining heated albumin gel with liquid platelet-rich fibrin before placement into the defect. The protocol follows the procedures described in the study protocol
干预措施: Modified Minimally Invasive Non-Surgical Technique (MINST) (Procedure)
MINST Alone
Participants will receive modified minimally invasive non-surgical periodontal therapy (MINST) alone. The procedure will be performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes while preserving root cementum and minimizing soft tissue trauma. No platelet-rich fibrin or other regenerative biomaterial will be applied.
干预措施: Modified Minimally Invasive Non-Surgical Technique (MINST) (Procedure)
MINST + Extended Platelet-Rich Fibrin (e-PRF)
Participants will receive modified minimally invasive non-surgical periodontal therapy (MINST) followed by the application of autologous extended platelet-rich fibrin (e-PRF) into the intrabony periodontal defect. MINST will be performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes while preserving root cementum and minimizing soft tissue trauma. The e-PRF will be prepared from the participant's peripheral blood by combining heated albumin gel with liquid platelet-rich fibrin before placement into the defect. The protocol follows the procedures described in the study protocol
干预措施: Extended Platelet-Rich Fibrin (e-PRF) (Biological)
结局指标
主要结局
Change in Probing Depth (PD)
时间窗: Baseline and 6 months after treatment
Change in periodontal probing depth (PD), measured in millimeters using a UNC-15 periodontal probe with a standardized probing force. Measurements are obtained using a patient-specific acrylic stent to ensure reproducibility.
次要结局
- Clinical Attachment Level (CAL)(Baseline, 3 months, and 6 months after treatment)
- Change in Gingival Recession (GR) measured using a UNC-15 periodontal probe(Baseline, 3 months, and 6 months after treatment)
- Change in Radiographic Intrabony Defect Depth measured using standardized periapical radiographs and ImageJ software(Baseline and 6 months after treatment)
- Patient Satisfaction (VAS)(During the first postoperative week after treatment)
研究者
Samuel Michael Mikhail
Principal Investigator, Postgraduate Researcher in periodontology
Cairo University