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临床试验/CTRI/2024/06/068695
CTRI/2024/06/068695尚未招募不适用

Comparative analysis of Injectable platelet rich fibrin (i-PRF) and Microneedling (MN) for gingival augmentation in thin gingival biotype patients: A randomized clinical trial

Masood Kamal1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年6月20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
44
试验地点
1
主要终点
Increase in gingival thickness and keratinized tissue width will be measured after interventions

研究概览

简要总结

Gingiva is the part of the oral mucosa that surrounds the necks of the teeth and covers the alveolar processes of the jaws .  The gingival biotype has been used to describe the thickness of the gingiva in the faciopalatal dimension. and it is a genetically determined trait.

Characteristics of thin gingival biotype - Highly scalloped gingival tissue usually may present with slight gingival recession, Delicate and thin periodontium, Tissue appears friable with a minimal zone of attached gingiva.

The response of thin gingival biotype to various stimuli or conditions can differ from that of thicker biotypes. Here are some considerations regarding the tissue response to thin gingival biotype: Increased susceptibility to recession due to trauma from various factors such as toothbrushing, periodontal procedures, or orthodontic treatment. Thin gingival tissues may have a reduced blood supply compared to thicker tissues. This can impair the tissue’s ability to heal and resist infection.

Thin gingival  biotype be converted or enhanced into thick biotype by following procedures i.e. The use of connective tissue grafts, Acellular dermal matrix , Use of platelet-rich fibrin (PRF) membrane etc.

Purpose of the study- Due to the positive effects of  i-PRF and microneddling on the biological potential, neoangiogenesis,  neocollagenesis and wound-healing because of various cells and growth factors i.e. white blood cells, platelets, transforming growth factor-β and collagen-1 mRNA, platelet-derived growth factors, connective tissue growth factor and fibroblast growth factors .

In light of these factors, this study will evaluate the effects of standalone i-prf and microneedling on gingival thickness and keratinized tissue width in individuals with thin gingival biotypes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • (1) Patients with age ≥18 years (2) Patients with Gingival thickness of the mandibular anterior teeth ≤1.5mm (Seibert and Lindhe-1989).14 (3) Patients with no malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth.
  • (4) Systemically healthy patients.
  • (5) Non-smoker patients.
  • (6) Patients who will give an informed consent.

排除标准

  • (1) Patients with active orthodontic treatment.
  • (2) Patients with history of previous periodontal surgery in last 6 months.
  • (3) Patients with any systemic disease affecting periodontal health.
  • (4) Patients currently using blood thinners.
  • (5) Patients using any drugs that might lead to gingival enlargement.
  • (6) Pregnant ladies or lactating mothers.

结局指标

主要结局

Increase in gingival thickness and keratinized tissue width will be measured after interventions

时间窗: increased gingival thickness and keratinized tissue width will be measured at 1 month 3 month 6 month

次要结局

  • Secondary outcomes in this trial are Plaque index Gingival index Pocket depth Clinical attachment level(All above mentioned parameters will be measured at baseline 1 month 3 month 6 month)

研究者

发起方
Masood Kamal
申办方类型
Other [Principal Investigator]
责任方
Principal Investigator
主要研究者

Masood Kamal

King georges medical university

研究点 (1)

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