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临床试验/NCT07437209
NCT07437209已完成4 期

Platelet-rich Fibrin With Minocycline Versus Arestin in Non-surgical Periodontal Therapy: A Split-Mouth Randomized Controlled Clinical Trial

Center for Advanced Rejuvenation and Esthetics1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
15
试验地点
1

研究概览

简要总结

Periodontitis is a chronic, biofilm-modulated inflammatory disease characterized by microbial dysbiosis and a dysregulated host immune response, eventually resulting in the gradual breakdown of the periodontal attachment apparatus. While non-surgical periodontal therapy (NSPT) remains the first choice of treatment, its capability to completely resolve inflammation and pocketing in moderate disease severity may be limited, supporting the use of adjunctive antimicrobial or biologic interventions. Platelet-rich fibrin (PRF) and locally administered antibiotics, including minocycline, have individually shown clinical advantages; nonetheless, evidence assessing their combined utility remains unexplored. This split-mouth randomized controlled clinical trial (RCT) aims to compare the clinical efficacy of PRF combined with minocycline versus minocycline microspheres hydrochloride (Arestin) as adjuncts to NSPT in patients with Stage II or III, Grade A or B periodontitis.

详细描述

Periodontitis is a chronic, biofilm-modulated inflammatory disease characterized by microbial dysbiosis and a dysregulated host immune response, eventually resulting in the gradual breakdown of the periodontal attachment apparatus. While non-surgical periodontal therapy (NSPT) remains the first choice of treatment, its capability to completely resolve inflammation and pocketing in moderate disease severity may be limited, supporting the use of adjunctive antimicrobial or biologic interventions. Platelet-rich fibrin (PRF) and locally administered antibiotics, including minocycline, have individually shown clinical advantages; nonetheless, evidence assessing their combined utility remains unexplored. This split-mouth randomized controlled clinical trial (RCT) aims to compare the clinical efficacy of PRF combined with minocycline versus minocycline microspheres hydrochloride (Arestin) as adjuncts to NSPT in patients with Stage II or III, Grade A or B periodontitis.

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 (Participant)

盲法说明

Participants do not know which site is receiving which treatment.

入排标准

性别
All
接受健康志愿者

入选标准

  • Male and Female subjects requiring non-surgical periodontal therapy• No contraindications to periodontal treatment

排除标准

  • previous periodontal treatment within the past 6 months;
  • local or systemic antibiotic treatment within the past 3 months;
  • diagnosis of Stage I/ or IV periodontitis;
  • poor oral hygiene defined as a full-mouth plaque score >30%;
  • history of radiation or immunosuppressive therapy;
  • presence of neurologic disorders, major mechanical obstruction to mouth opening, or acute temporomandibular capsulitis;
  • systemic conditions that may compromise bone metabolism or wound healing such as metabolic bone disease, uncontrolled diabetes;
  • history of substance abuse such as drug or alcohol; or
  • current pregnancy, nursing, or planning pregnancy during the study period.

研究者

发起方
Center for Advanced Rejuvenation and Esthetics
申办方类型
Network
责任方
Principal Investigator
主要研究者

Nathan Estrin

Periodontist

Center for Advanced Rejuvenation and Esthetics

研究点 (1)

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