跳至主要内容
临床试验/CTRI/2024/08/072966
CTRI/2024/08/072966尚未招募不适用

Comparative evaluation of Hyaluronic Acid and injectable Platelet Rich Fibrin (I-PRF) as a non-surgical approach for management of black triangle

Mansi Pal1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
closure of black triangle or reconstruction of interdental papilla

研究概览

简要总结

The interdental papillary deficiency or the Black triangle (BT)" is a large concern for dentists and patients. Loss of interdental papilla may lead to the formation of unappealing dark triangles, resulting in food impaction and plaque buildup. This soft tissue is delicate and fragile; is susceptible to inflammation leading to recession, bone loss or both , due to its low blood supply. In addition to positively affecting smile esthetics, interdental papillae are important to prevent the impaction of food between the teeth and important role in improved phonetics . Non-surgical attempts to treat, these methods are invasive and time-consuming.Non-surgical attempts to treat, these methods are invasive and time-consuming.

Hyaluronic acid (HA) is an essential glycosaminoglycan of the extracellular matrix of the periodontal tissues, and the majority of cells can produce it during several phases of their cell cycle. It is involved in tissue repair and wound healing by stimulating cell proliferation, migration and interaction with several growth factors.

HA has a crucial role in space-filling owing to its hygroscopic nature. Moreover, it regulates osmotic pressure and enhances tissue lubrication and resiliency, which helps in maintaining the structural and homeostatic integrity of tissues the injection of HA showed promising clinical efficacy in the treatment of gingival papilla defects in several studies.

Platelet rich fibrin (PRF) is a type of platelet gel; a matrix of autologous fibrin, which has scored over platelet rich plasma by virtue of its properties, ease of preparation, and cost effectiveness. Platelet cytokines, platelet derived growth factors (PDGF)-α and (PDGF)-β, transforming growth factor beta (TGF)-β and insulin-like growth factor-1 (IGF-1) are gradually released as fibrin matrix is resorbed, aiding the process of healing.

“Injectable platelet-rich fibrin (I-PRF) ”is the most recent and successful advancement in PRF.  I-PRF is referred to be an advanced type of PRF since it is injected (autologous PRF) into afflicted soft tissues, mucous membranes, or skin. It also has special qualities in the regeneration of human tissues. Gene therapy, tissue engineering, and platelets have all been demonstrated to be effective sites for signaling pathways such as platelet-derived growth factor.  that i-PRF demonstrated the ability to release higher concentrations of various growth factors and induced higher fibroblast migration and expression of PDGF, TGF-β, and  collagen .

The purpose of this study is to check the clinical efficacy of injectable- platelet rich fibrin (I- PRF) in comparison to commercially available Hyaluronic acid injections for the treatment of Black triangle.

PROCEDURE : written informed consent form explaining the nature of the study and procedure will be explained to the patient and duly signed by the patient.

v Pre operating phase**:** Consisting of oral hygiene instructions, scaling, root planing.

v Maintenance phase:

·       Baseline recording of clinical parameters

Ø  The degree of papillary deficiency will be recorded according to Nordland and Tarnow classification(1992).

Ø Distance between the contact point of affected teeth to the tip of the papillary point will be measured.

Ø Clinical photographs will be taken.

v Injection phase:

·       Group A: Hyaluronic Acid Group

Ø 3 doses of commercially available hyaluronic acid will be given at each papilla site: at baseline, 3-week and 6-weeks intervals.

·      Group B: Injectable-Platelet Rich Fibrin (I-PRF) Group

Ø Blood sample will be collected in a test tube after that centrifugation will be done for 3 minutes at a low speed (700rpm) to produce a yellow- orange color fluid that is known as injectable platelet-rich fibrin, after that this fluid will be injected to the papilla site. Three doses will be given at each papilla site: at baseline, 3-week and 6-weeks intervals.

v

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Above 18 years of age
  • Papillary deficiency types I or II, according to Nordland and Tarnow classification (1998) will be selected.
  • Patients willing to participate in the study
  • Systemically healthy patients.

排除标准

  • Papillary deficiency types III according to Nordland and Tarnow classification
  • Open contacts between affected teeth.
  • 3 Subjects suffering from any systemic diseases or systemic conditions
  • Pregnant and lactating women
  • Alcoholics.

结局指标

主要结局

closure of black triangle or reconstruction of interdental papilla

时间窗: three doses given at each papilla at baseline,3 weeks ,6 weeks

次要结局

  • no food lodgement occur so pocket formation decreases.(6th weeks)

研究者

发起方
Mansi Pal
申办方类型
Other [SELF- (Principle investigator)]
责任方
Principal Investigator
主要研究者

Mansi Pal

king georges medical university

研究点 (1)

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