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临床试验/CTRI/2024/08/072707
CTRI/2024/08/072707尚未招募Phase 3 4

Comparative evaluation of microneedling with Hyaluronic acid injection and vitamin C injection in the management of thin gingival phenotype: A Randomised clinical study

Dr Chandrima Biswas1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
1. Gingival thickness is measured using Number 15 Endodontic Spreader when inserted transgingivally. Stopper will be used as reference points and exact measurement will be recorded using endo ruler.

研究概览

简要总结

Thick gingiva is
usually associated with wide zones of keratinized tissue and flat gingival
contour, whereas thin gingiva is associated with a narrow band of keratinized
tissue, and a scalloped gingival margin. The periodontal phenotype as a
definition is the combination of gingival phenotype and bone morphotype
(buccal bone plate thickness). Gingival phenotype involves gingival thickness
(GT) and keratinized tissue width (KTW). Thin phenotypes are more
vulnerable to injury and likely to induce gingival recession than thick
phenotypes because thin gingiva can have an effect on plaque-related
inflammatory lesions, making it prone to tissue destruction. Numerous
applications, including non-surgical periodontal therapy, mucogingival
therapy, guided tissue regeneration (GTR), and implant dentistry, have shown
evidence of impact of gingival thickness. Patients with gingiva less than 1.5
mm thick experienced attachment loss after non-surgical periodontal therapy,
whereas no attachment loss was seen at sites with gingiva over 2 mm thick. A
significant moderate correlation occurred between a critical gingival
thickness threshold of >1.1 mm and weighted mean root coverage and
weighted complete root coverage according to a systematic review and
meta-analysis. Thin gingival thickness of less than 2 mm is associated with
slightly greater initial peri-implant bone loss around implants compared with
thick gingival thickness for securing the supra crestal tissue attachment of
the gingiva. Thus, the presence of soft tissues with a thickness >2.0 mm
around implants is crucial in preserving healthy peri-implant tissues and
preventing alveolar bone loss through the biological protection. Based on
these findings, surgical procedures like gingival tissue augmentation have
been proposed to increase gingival thickness to maintain the biologic width
and minimize alveolar bone loss. However, postoperative complications, such
as uncontrolled bleeding, pain, and infection of the palatal donor site,
limit its establishment as a routine procedure. To avoid these complications,
new methods are being studied.

Hyaluronic acid (HA), a naturally occurring polysaccharide, is considered an important component of the extracellular matrix in connective tissues of the human body. HA participates in various physiologic and structural processes that preserve tissue integrity, such as cellular and extracellular interactions, modulation of the inflammatory process, interactions with growth factors, tissue healing, collagen synthesis, regulation of the osmotic pressure, and tissue lubrication.

Vitamin C is a proven anti-inflammatory agent and also exerts a reducing and antioxidant effect, scavenges free radicals, and acts as an enzyme cofactor in cells. This nutrient is considered to be an important dietary oxidant for periodontal health, as it plays a crucial role in preventing and slowing the progression of periodontal disease by inducing the differentiation of periodontal ligament progenitor cells. Vitamin C has a very important role in collagen biosynthesis (collagen type I), as it helps in fibroblasts proliferation. It reduces the potentiality of scarring via inhibiting cross-linking of collagen fibers and fibrosis. It acts as a cofactor in hydroxyproline synthesis to produce collagen type IV and improves endothelial cell vitality and function. Vitamin C and Hyaluronic acid promote growth of tissues and wound healing by inducing synthesis of fibroblasts, collagen, elastin and growth factors which can effect gingival thickness and width of keratinised tissue.

Microneedling (MN) is also known as “percutaneous collagen induction therapy". Microinjuries created by MN result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors, such as platelet-derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors are released. In MN, the tissue responds as if experiencing tissue trauma and the body’s own collagen production is induced to preserve skin integrity. Growth factors are released immediately after injury, inducing the proliferation of new cells, and fibroblasts are transformed into collagen and elastin fibers from day 5 up to week 8. Fibroblasts produce collagen and elastin fibers by migrating to the point of intrusion for wound closure. Newly formed fibers thicken the tissue during a process is known as neocollagenesis. Fibroblasts also trigger neoangiogenesis by stimulating the proliferation of endothelial cells in the vessels. However there is very limited literature on microneedling and comparing the effects of Vitamin C and Hyaluronic acid on thin gingival phenotype. So this study will be  conducted to evaluate and compare the effects  of microneedling with hyaluronic acid injection and Vitamin C injection in the management of thin gingival phenotype.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • 18-45 years individuals with no systemic diseases, with thin gingival phenotype less than or equal to 1.5mm and presence of full mouth plaque and gingival index less than 1, with no smoking habits or no malocclusion, crowding, fillings, missing or supernumerary teeth, blood-bone conditions should be absent, presence of minimum of 20 natural teeth.

排除标准

  • Patients undergoing active orthodontic treatment, under antibiotics in the past 6 months, who have undergone periodontal therapy in the past 6 months, who are allergic to hyaluronic acid and vitamin C and pregnant and lactating women and who are taking blood thinners or drugs leading to gingival enlargement.

结局指标

主要结局

1. Gingival thickness is measured using Number 15 Endodontic Spreader when inserted transgingivally. Stopper will be used as reference points and exact measurement will be recorded using endo ruler.

时间窗: Baseline, 45 days, 3 months

2. Keratinised tissue width will be measured from gingival margin to muco gingival junction using UNC 15 probe.

时间窗: Baseline, 45 days, 3 months

次要结局

  • Gingival index score (Loe and Silness) and Plaque index score (Silness and Loe)(baseline, 45 days and 3 months)

研究者

发起方
Dr Chandrima Biswas
申办方类型
Other [Self sponsored]
责任方
Principal Investigator
主要研究者

Dr Chandrima Biswas

Sri Rajiv Gandhi College of Dental Sciences and Hospital

研究点 (1)

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