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临床试验/CTRI/2024/07/070193
CTRI/2024/07/070193尚未招募2 期

Comparative evaluation of efficacy of doxycycline incorporated platelet rich fibrin (PRF-D) versus platelet rich fibrin (PRF) alone in the treatment of intrabony defects - A randomized control clinical trial

DOGIPARTHI MOUNICA1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年10月14日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
1.Linear bone growth

研究概览

简要总结

Periodontal treatment aims at treating the infection caused by pathogenic bacterial biofilm, arresting the progression of disease and reconstituting the structures of the periodontium that are lost, ultimately preventing tooth loss. Regeneration is the ultimate goal of periodontal therapy.

Currently a novel approach to attain periodontal regeneration is the use of Platelet rich fibrin (PRF), that releases polypeptide growth factors (PGFs) which have the ability to regulate cell proliferation, chemotaxis, and differentiation, that may directly contribute to formation of new tissues. PRF is a biomimetic agent which shows favourable results in regeneration of periodontal tissues when used alone or as a combination therapy.

Post-operative microbial colonization can hamper the outcomes of periodontal regenerative therapy. Incorporation of PRF with antibiotics could be a beneficial approach in terms of minimizing the microbial burden and enhancing the results of regenerative procedures.

Doxycycline is proven to be an effective antibiotic against periodontal pathogens and also has an additional benefit of possessing anti-collagenolytic property. Therefore, a combination of platelet rich fibrin and doxycycline can be hypothesized as a promising technique to aid in periodontal regeneration and also to reduce bacterial colonization.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Periodontitis patients with the presence of intra-bony defect (IBD) ≥3 mm deep (distance between alveolar crest and base of the defect) on an intraoral periapical radiograph [IOPA].
  • 2.Interproximal probing depth (PD) ≥5 mm after phase I therapy in asymptomatic maxillary/ mandibular molar teeth.

排除标准

  • 1.Patients with systemic conditions known to affect the periodontal status.
  • 2.Patients taking medications known to affect the outcomes of periodontal therapy.
  • 3.Pregnant and lactating women.
  • 4.Teeth with furcation defects, non-vital teeth, and mobility of at least grade II.
  • 5.History of periodontal surgery in past one year.
  • 6.Patients with unacceptable oral hygiene.

结局指标

主要结局

1.Linear bone growth

时间窗: 10 days, 1 month, 6 months, 9 months

2.Wound healing index

时间窗: 10 days, 1 month, 6 months, 9 months

次要结局

  • 1.Probing depth reduction(2.Relative attachment level gain)

研究者

发起方
DOGIPARTHI MOUNICA
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DOGIPARTHI MOUNICA

SRI BALAJI DENTAL COLLEGE

研究点 (1)

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