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临床试验/NCT07313254
NCT07313254已完成不适用

Clinical And Radiographic Evaluation Of Zinc Substituted Nanohyrdoxyappatite Bone Graft And Advanced Platelet Rich Fibrin Block In The Treatment Of Periodontal Intrabony Defects: A Randomized Controlled Study

Suez Canal University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
measurement of gingival indices

研究概览

简要总结

Periodontal intrabony defects pose a significant challenge in clinical dentistry due to their complex anatomy and limited regenerative potential. Recent advancements in biomaterials and regenerative techniques have introduced novel approaches to enhance periodontal healing. This study evaluates the clinical and radiographic outcomes of using nano-hydroxyapatite (nHA) and zinc-substituted nano-hydroxyapatite (Zn-nHA) in combination with advanced platelet-rich fibrin (A-PRF) blocks for the treatment of periodontal intrabony defects.

Nano-hydroxyapatite, a biomimetic material, has shown promise in promoting bone regeneration due to its osteoconductive properties. Zinc substitution further enhances its biological activity by incorporating antimicrobial and osteoinductive characteristics. Advanced PRF, a second-generation platelet concentrate, provides a scaffold rich in growth factors and cytokines, which synergistically supports tissue regeneration.

详细描述

Periodontitis causes deep periodontal pockets due to bone and attachment loss. Zinc-substituted hydroxyapatite enhances bone regeneration, while PRF promotes healing through growth factors. Their combination as a PRF block offers a promising approach for periodontal defect repair. This randomized controlled clinical trial was conducted to compare the effectiveness of zinc-substituted nano-hydroxyapatite alone and in combination with platelet-rich fibrin (PRF) block in the treatment of intrabony periodontal defects. Thirty patients diagnosed with periodontitis were selected based on defined inclusion and exclusion criteria and were randomly allocated into three equal groups. Each group received a different grafting material using a full-thickness mucoperiosteal flap surgical technique. Standardized clinical parameters-including gingival index, plaque index, probing pocket depth, and clinical attachment level-were recorded at baseline and six months post-operatively. Radiographic assessments were also performed to evaluate bone changes using digital imaging and image analysis software. The zinc-substituted grafts were prepared using a chemical process, and PRF blocks were created by combining advanced and injectable PRF with the graft material

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
None

盲法说明

Masking Description

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adequate oral hygiene conditions.
  • Age range from 20 years to 50 years.
  • All patients will be physically healthy.
  • Patients who are co-operatively motivated.

排除标准

  • Those who smoke.
  • Women who are pregnant.
  • Patients with poorly controlled systemic diseases which preclude local anesthesia or surgical procedures.

结局指标

主要结局

measurement of gingival indices

时间窗: From enrollment to the end of treatment at 6 months

Gingival index (Loe et al.,1963): Score Criteria: 0- No inflammation. 1. Mild inflammation, slight change in color, slight edema, no bleeding on probing. 2. Moderate inflammation, moderate glazing, redness, bleeding on probing. 3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.

measurement of plaque indices

时间窗: 6 monthes

• Plaque index (Silness et al.,1964): We determine the amount of plaque on the tooth surface using a scale from 0 to 3: 0- No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which could not be seen with the naked eye. But only by using disclosing solutions or by using probe. 2. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which could be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

measurement of probing pocket depth

时间窗: 6 months

Probing pocket depth : Probing pocket depth (PD) is measured by using William's graduated probe from the free gingival margin to the base of the periodontal pocket.

Measurement of Clinical attachment level

时间窗: 6 months

The clinical attachment level (CAL) is measured by using periodontal probe from the cemento - enamel junction to the bottom of the pocket at each selected site.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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