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临床试验/CTRI/2025/09/094611
CTRI/2025/09/094611尚未招募2 期

Reconstruction of interdental papilla using hyaluronic acid gingival fillers: A comparative approach in thick and thin gingival phenotypes-A Clinical Trial

Dr Pallavi Holal1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年11月18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
20
试验地点
1
主要终点
To compare the patient reported outcomes after Hyaluronic acid gel application in thick and thin gingival phenotypes.

研究概览

简要总结

The interdental papilla is a part of the gingival tissue that fills the space between teeth, known as the gingival embrasure located just beneath  the area where the teeth come into contact. It is gingival tissue that is keratinized and covered by stratified squamous epithelium.

In the case of anterior teeth the interdental papilla usually has a pyramidal shape, while in posterior teeth, it adopts a more col shaped form. The facial and lingual surfaces gradually taper  towards  the interproximal contact area, while the mesial and distal surfaces exhibit a slight concavity.

  The form,  location, and existence of  the interdental papilla are  influenced by the underlying alveolar  bone, the proximal contact point, and the approximal area of adjacent  teeth. Cohen was the first to describe its morphology

The papillae  in  the maxillary anterior  region  plays  an  important role in dental aesthetics. An open gingival embrasure can lead to various complications, including  food  impaction, increased plaque  buildup,  reduced self-cleansing ability, and a higher risk of periodontal disease2.

The absence of papilla results in a visible gap between teeth, commonly referred to as a black triangle1. Several factors contribute to the formation of black triangles, such as periodontal disease, root angulation, triangular-shaped crowns, improper brushing techniques, aging, tooth loss, and the length of the embrasure area1.

Several techniques can be utilized to restore missing gingival papilla, including restorative procedures, orthodontic treatment, interdisciplinary approaches and various surgical augmentation  methods4. Among  the  surgical  options,  the  autogenous   subepithelial connective tissue graft  is highly recommended due  to its superior aesthetics, long-term stability,  predictable and reproducible outcomes. However, its  major drawback lies in the need for donor site that creates an additional surgical site to harvest the graft, which may reduce patient’s willingness2.

There is a greater emphasis on minimally invasive periodontal therapy, as it offers the advantages of faster healing, enhanced aesthetics, minimally invasive, and greater patient compliance2.

Hyaluronic acid (HA) is recently used as a gingival filler for the reconstruction of lost interdental papillae1. It is an important  part of the structural matrix, HA plays a crucial role in maintaining tissue integrity. Its  functions include intercellular communication, relieves pain,  faster  wound  healing, stimulating  neovascularization, and helps in collagen synthesis1 .In  2010, Beker et al. were the first to  utilize  injectable  hyaluronic acid (HA) filler for the treatment of papillary recession, demonstrating  promising  outcomes2.

Gingival phenotype  refers to the thickness of the gingiva and width of keratinized tissue around  the teeth(5). It plays  a crucial  role in determining the success of various dental treatments ,particularly periodontal procedures such as root coverage techniques and dental implant placement6.  Assessing the gingival phenotype before initiating treatment is essential, as different phenotypes  respond differently to inflammation, surgical intervention and restorative procedures. Proper evaluation helps  improve  treatment  outcomes and  prognosis ,ensuring more predictable and stable results6 .

Gingival  phenotype are generally categorized  into 2 types; thick flat and thin scalloped. When the gingival thickness measures 1.5 mm or more  , it is classified as the thick gingival phenotype. In contrast, gingiva measuring less than 1.5 mm in thickness is referred to as thin gingival phenotype.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • 1.Systematically healthy patient.
  • 2.Patient aging between 18-35 3.Good oral hygiene.
  • 4.Periodontal pocket less than or equal to 4mm.
  • 5.No radiographic evidence of interdental bone loss.
  • 6.Patient who have agreed to participate in the study.
  • 7.The respective teeth should be free from caries with no fixed prosthesis or orthodontic appliance.

排除标准

  • Pregnancy and lactacting mothers
  • Tobacco users and alcoholics 3.Patients with systemic condition/disease.
  • Known allergy of Hyaluronic acid.
  • 5.Fixed orthodontic appliances.
  • Tooth mobility
  • Consumption of drugs causing gingival hyperplasia.
  • 8.Interdental bone loss.
  • 9.Inadequate attached gingiva on study teeth.

结局指标

主要结局

To compare the patient reported outcomes after Hyaluronic acid gel application in thick and thin gingival phenotypes.

时间窗: Baseline, 3 weeks, 3 months, 6 months

次要结局

  • 1. To evaluate the effectiveness of Hyaluronic acid gel in enhancing interdental papilla in thick and thin gingival phenotypes.(2. To compare the effectiveness of Hyaluronic acid gel in enhancing interdental papilla fill in thick and thin gingival phenotypes.)

研究者

发起方
Dr Pallavi Holal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Pallavi Holal

KVG Dental College and Hospital

研究点 (1)

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