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临床试验/CTRI/2025/07/091007
CTRI/2025/07/091007尚未招募2 期

Adjunctive use of iPRF with or without Erbium Root Biomodification in the management of gingival recession coverage using a coronally advanced flap A randomized controlled trial

Thamaraiselvan Murugan1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年8月12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
48
试验地点
1
主要终点
Mean Recession Coverage (MRC)

研究概览

简要总结

Gingival Recession is the apical migration of marginal gingiva as well as the fact that the latter is gradually displaced away from the cementoenamel junction, thereby exposing the root surface to the oral environment. Treatment options for this condition include coronally advanced flaptechnique and the lateral pedicle flap procedure,free gingival grafts etc  which aim to restore the gingival tissue. While healing occurs with the formation of a long junctional epithelium (JE), the risk of recurrence remains high. Efforts to facilitate true regeneration of the gingival tissue are ongoing. One such approach is root biomodification, which involves exposing the root collagen proteins to regenerating cells to promote true regeneration of epithelium and facilitate healing. This is typically done with agents like citric acid,enamel matrix proteins and fibronectin etc  though no agent has yet been identified as ideal or fully satisfactory.For successful regeneration, it is essential to have an intact fibrin attachment, which is critical for enabling true attachment of the periodontal tissue to the root surface. In Erbium-laser root biomodification, the use of the erbium laser facilitates the modification of the root surface, making it more conducive for fibroblast attachment, which is essential for periodontal healing. This technique enhances the root surface, improving its ability to support the attachment of regenerating cells, specifically fibroblasts, which play a crucial role in tissue repair and regeneration.When combined with iPRF (Injectable Platelet-Rich Fibrin), a form of platelet-rich fibrin derived from the patient’s own blood, this treatment approach may  show enhanced outcomes. iPRF  may provides fibrin  that support tissue healing and regeneration, stimulating fibroblast activity and accelerating the repair of periodontal tissues. The CAF technique can effective soft tissue coverage, while Erbium-laser root  biomodification may  optimise the root surface for fibroblast attachment and  may promotes tissue regeneration.Together, these three treatment modalities may  create a synergistic effect that supports more effective periodontal regeneration, reduces inflammation, and facilitates true attachment to the root surface.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Miller class 1 recession / RTI 1 width of keratinised gingiva greater than or equal to 2mm apical to gingival margin Probing Depth(PD) lesser than or equal to 3mm .

排除标准

  • 1.patients with systemic disease 2.patient under medications that contraindicate periodontal surgery 3.smokers 4.pregnant or lactating mothers 5.recession defects with caries or non carious lesions with or without pulpal pathology.

结局指标

主要结局

Mean Recession Coverage (MRC)

时间窗: Baseline | 1 month | 3 month | 6 month

Complete Recession Coverage (CRC)

时间窗: Baseline | 1 month | 3 month | 6 month

次要结局

  • Width of Keratinised Gingiva (WKG)(Healing Index (HI))

研究者

发起方
Thamaraiselvan Murugan
申办方类型
Other [Self funding ]
责任方
Principal Investigator
主要研究者

Thamaraiselvan Murugan

Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences

研究点 (1)

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