Effect of Monolayer Versus Multilayer Leucocyte-Platelet Rich Fibrin (L-PRF) in Interdental Papillary Reconstruction" (A Randomized Controlled Clinical Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- clinical assessment
研究概览
简要总结
The interdental papilla is very small but it has a great implication from an aesthetic view, more specifically in the anterior region because it is always displayed during smiling. The lack of interdental papilla due to periodontal disease or periodontal therapy leads to aesthetic problems with food stagnation as well as phonetic problem due to the space that allows passage of the air or saliva. Leukocyte-PRF (L-PRF) membrane was developed which includes the majority of the platelets in addition to half of the leukocytes so that lymphocytes as well as the platelet growth factors are trapped inside a fibrin network. Multiple layers of L-PRF may have observable effect on tissue regeneration because it increases the number of growth factors and acts as a strong scaffold which helps in creeping of the cells along it as it remains active and in place for more than 7 days. Thus, the aim of this study will be conducted to compare the effect of one layer versus multiple layers of L-PRF in interdental papillary reconstruction.
详细描述
A total of 20 patients will be selected who are caring about esthetics and concerned to go through the management of eradication of "black triangles" by interdental papillae reconstruction in esthetic zone and systemically free with Nordland's class I or II and The vertical distance from the interdental contact point to the crest of the interdental bone is ≥ 6 mm as measured by bone sounding, A band of keratinized tissue should be present around the test teeth ≥ 2 mm, Gingival biotype of the area to be treated is ≥ 2 mm in thickness.
The study protocol will be explained in details to all patients. Then a signed informed consent will be obtained from the patients. The data obtained from patients as well as the results of the follow up will be kept confidential.
The study will be introduced to ethics' committee of Faculty of Dentistry Ain Shams University and has to be approved before the start of the study Eligible patients will be randomized in a 1:1 ratio into two groups; (Group I) included 10 patients and (Group II) included 10 patients. The computer-generated randomization assignment (blocks of 4) and allocation concealment will be performed by sealed envelopes containing the randomization number prepared by non involved member and sent to principle investigator to assign the interventions to patients Group I: 10 patients will undergo interdental papillary reconstruction using one layer of L-PRF.
Group II: 10 patients will receive interdental papillary reconstruction using multiple layers of L-PRF (Two or more according to the compressibility in which if ≥1mm, it needs one more layer, and if ≤1 mm, then no need to more than 2 layers; it cannot be standardized).
Procedure:
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with black triangles.
- •Both genders aged from 18-40 years.
- •Patients should be systemically free.
- •Patients with Nordland's class I or II. Nordland and Tarnow classified the interdental papilla loss; the classification is based on three anatomic landmarks: the contact point interdentally, the coronal level of the CEJ interproximally and the facial apical level of the cemento-enamel junction (CEJ). [Nordland WP, et al, 1998] Four classes were identified
- •Normal: The interdental papilla fills up the whole embrasure to the interproximal contact point.
- •Class I: Presence of the tip of the papilla between interdental contact point and the interproximal CEJ.
- •Class II: Presence of the tip of the papilla at the interproximal CEJ or apical to it but still coronal to the facial CEJ.
- •Class III: Presence of the tip of papilla at similar plane with the labial CEJ or apical to it.
- •The vertical distance from the interdental contact point to the crest of the interdental bone is ≥ 6 mm as measured by bone sounding.
- •A band of keratinized tissue should be present around the test teeth ≥ 2 mm.
- •Gingival biotype of the area to be treated is ≥ 2 mm in thickness.
排除标准
- •Acute periapical lesion.
- •moderate to severe form of periodontitis.
- •Pregnancy and lactation.
- •parafunctional habits.
- •Smoking, alcoholics or drug abusers.
- •Teeth with interdental spacing, rotation or inclination or crowding.
- •Vulnerable group of patients.
研究组 & 干预措施
single layer of L-PRF
single layer of L-PRF will be put in the vertical incision
干预措施: interdental papilla reconstruction with L-PRF (Procedure)
multiple layers of L-PRF
multiple layers of L-PRF will be put in the vertical incision
干预措施: interdental papilla reconstruction with L-PRF (Procedure)
结局指标
主要结局
clinical assessment
时间窗: change from baseline to 6 months
papillary height from the tip of the papilla to mesial line angle
次要结局
- volumetric analysis(change from baseline to 6 months)
研究者
Sara Amir ahmed Lashin
Principle investigator at Ain shams university
Ain Shams University