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临床试验/CTRI/2024/06/068420
CTRI/2024/06/068420尚未招募2 期

Impact of Xenogenic collagen matrix on COL1A1 gene expression in patients with multiple gingival recession defects- A Randomised Controlled trial.

saveetha dental college and hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月30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
30
试验地点
1
主要终点
Mean root coverage (MRC), recession height (RH), recession width (RW), width of keratinized tissue (WKT), probing pocket depth (PPD), clinical attachment level gain (CAL).

研究概览

简要总结

Gingival recession is defined as the apical shift of the marginal gingiva

resulting in dentin hypersensitivity, root caries, an unaesthetic gingival appearance.

Management of gingival recession include conventional flap and autogenous grafting

procedures. Due to the limited tissue availability and post-operative morbidity, xenogenic

collagen matrices are gaining popularity in recent days. In this context, the aim of this study

was to assess the effectiveness of xenogenic collagen matrix (Fibro-Gide®) with coronally

advanced flap compared to connective tissue graft with coronally advanced flap in the management of RT1 and RT2 gingival recessions.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

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

入选标准

  • Age group 18 to 60 years.
  • RT 1 and RT 2 gingival recession in upper teeth with a recession depth ≥ 2mm.
  • Probing depth ≤ 4mm.

排除标准

  • Systemic disease
  • presence of caries at recession site.
  • tooth with mobility.
  • Pregnancy
  • use of medications with potentially adverese effects on periodontal tissues 6.

结局指标

主要结局

Mean root coverage (MRC), recession height (RH), recession width (RW), width of keratinized tissue (WKT), probing pocket depth (PPD), clinical attachment level gain (CAL).

时间窗: baseline | 6months.

次要结局

  • COL1A1 gene expression(baseline)

研究者

发起方
saveetha dental college and hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Arvina Rajasekar

Saveetha dental college and hospital, SIMATS UNIVERSITY

研究点 (1)

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