跳至主要内容
临床试验/CTRI/2025/07/090438
CTRI/2025/07/090438尚未招募3 期

Assessment of gingival papilla regeneration using an innovative approach: Hemolaser therapy

Dr Sheetal G Naik1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年7月18日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
To assess and compare the papillary gain with hemolaser therapy during first, second and third

研究概览

简要总结

As a part of smile’s harmony, interdental papilla plays an important role in orofacial esthetics. Loss of

interdental papilla of gingiva can lead to black spaces in odontology, which affects the smile esthetics

and leads to phonetics and functional damage.1 This black triangle can even cause food impaction. The

etiology of this loss is mainly because of gingival inflammation, attachment loss, resorption of

interproximal bone height and periodontal surgical therapy. Growth factors, platelet derivatives and

low level laser therapy has been used previously for papillary regeneration, but papillary reconstruction

is most challenging problem because of the minor blood supply.

2 Surgical reconstruction of interdental papilla also presents as challenge in obtaining good results.3 Photo biomodulation therapy (PMBT)

modulates biologic activity and has shown to reduce inflammation and pain, prevent necrosis and has

shown to stimulate healing of wound and regeneration of tissues. PMBT has also been proven to

enhance the production of adenosine triphosphate, vasodilatation and tissue regeneration.4 Hemolaser

therapy is a modified PBMT which regenerates papilla and fills the black triangles. The aim of this

study is to evaluate the effectiveness and efficiency of hemolaser therapy on papillary regeneration.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Age group of 18-65 years.
  • Individuals with class 1 and class 11 papillary loss (Norland and Tarnow 1998)
  • Good oral hygiene
  • Adequate width of gingiva.

排除标准

  • Any systemic illness that can alter the outcome of the procedure
  • Edema, bleeding inflammation and gum retraction
  • Gingival alterations
  • Dental defects like abfractions, irregularities or excess on the nearby dental surface
  • Abnormal frenal attachment 7.

结局指标

主要结局

To assess and compare the papillary gain with hemolaser therapy during first, second and third

时间窗: To assess and compare the papillary gain with hemolaser therapy during first, second and third | sessions on day 1, day 7 and day 14 respectively and during follow up period after 21 days.

sessions on day 1, day 7 and day 14 respectively and during follow up period after 21 days.

时间窗: To assess and compare the papillary gain with hemolaser therapy during first, second and third | sessions on day 1, day 7 and day 14 respectively and during follow up period after 21 days.

次要结局

  • Reduction of black triangles(21 days)

研究者

发起方
Dr Sheetal G Naik
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sheetal G Naik

The Oxford Dental College, Bangalore

研究点 (1)

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