跳至主要内容
临床试验/CTRI/2025/09/095434
CTRI/2025/09/095434尚未招募3 期

Comparative evaluation of i-prf with micro-needling and low-level laser application on post operative healing associated with open flap debridement in the treatment of stage iii periodontitis: A split mouth study

Tejaswini N1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月9日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Plaque index

研究概览

简要总结

Periodontitis is a chronic inflammatory disease affecting the supporting structures of the teeth, including the gingiva, periodontal ligament, and alveolar bone. It is primarily initiated by a dysbiotic bacterial biofilm but perpetuated by an exaggerated host immune response, leading to progressive tissue destruction and eventual tooth loss if untreated. The management of periodontitis aims to eliminate the microbial etiology, reduce inflammation, halt disease progression, and restore periodontal health. Initial therapy typically involves non-surgical approaches such as scaling and root planing combined with improved oral hygiene practices. In cases with persistent deep pockets or advanced disease, surgical interventions like open flap debridement, regenerative procedures, and use of biologics (such as platelet concentrates or growth factors) are employed to gain better access for debridement, facilitate tissue regeneration, and improve long-term outcomes. Injectable platelet-rich fibrin (i-PRF) is a concentrated autologous preparation rich in growth factors that promotes tissue regeneration and healing. When combined with micro-needling on the inner aspect of the flap (the connective tissue side), it enhances penetration and release of growth factors into the surgical site. This approach may accelerate soft-tissue healing, reduce post-operative inflammation, and improve clinical outcomes such as pocket depth reduction and attachment gain compared to flap surgery alone. Low-level laser therapy (LLLT) applied to the inner aspect of the flap during periodontal surgery enhances bio-stimulation, promoting faster and better-quality healing. By stimulating fibroblast activity, collagen production, angiogenesis, and reducing inflammation, LLLT improves tissue regeneration and reattachment to root surfaces.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy individuals.
  • Patients with Stage-III, Grade-A periodontitis Bilateral pockets with probing pocket depth greater than or equal to 6mm involving at least two or three teeth post phase-I therapy.

排除标准

  • History of antibiotic therapy within 6months.
  • Uncooperative patients.
  • Poor oral hygiene.
  • Pregnant and lactating women.

结局指标

主要结局

Plaque index

时间窗: at baseline, 1 month, 3 months

Gingival index

时间窗: at baseline, 1 month, 3 months

次要结局

  • Landry wound healing index(7th day, 14th day, 1 month.)
  • Probing pocket depth, Clinical attachment level, Gingival thickness(baseline & 3 months.)

研究者

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

Dr K SUNEETHA

Drs. Sudha and Nageswara rao Siddartha institute of dental sciences

研究点 (1)

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