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临床试验/CTRI/2025/09/094323
CTRI/2025/09/094323尚未招募2/3 期

Comparative evaluation of liquid phase concentrated growth factors with and without haemolaser therapy in anterior papillary reconstruction-a randomized clinical trial

Dr. Maturu Sai Sruthi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Anterior Interdental papillary gain.

研究概览

简要总结

Systemically healthy Participants with anterior interdental papillary loss will be selected from outpatient Department of Periodontology, Narayana Dental College and Hospital, depending upon the inclusion criteria. After obtaining written informed consent, the selected participants will be subjected to scaling and root planing, oral hygiene instructions will be advised .The participants will be recalled after 4 weeks, and Anterior Papillary loss measurements will be taken using a UNC -15 probe and digital photographs. The participants will be selected and randomly assigned by computer generated method into two groups, Group 1 will receive injectable liquid phase concentrated growth factors and haemolaser therapy will be done where laser will be passed without activation of the diode laser tip. Group 2 will receive injectable liquid phase concentrated growth factors with haemolaser therapy with activated laser

tip. Each papillary defect will be measured as a triangle with the height measured from the interdental contact point to the tip of papilla. Base will be measured as the distance between the proximal surfaces of the adjacent tooth surfaces at the tip of papilla. 10 ml of blood sample will be collected from antecubital region and transferred into the plain plastic tubes. The collected blood will be centrifuged, as per the sacco protocol and Liquid-phase concentrated growth factors are obtained by this method will be injected using an insulin syringe into the connective tissue layer at the base of the gingival papilla for both treatment groups after giving local anaesthesia at the recipient site.

Haemolaser therapy will be achieved through Photo Biomodulation. Pocket marker is used to mark 4 bleeding points on the gingiva  between two anterior teeth, that is at (coronal third of papilla, apical third of the papilla, mesial and distal surfaces of the papilla). Later bleeding will be provoked by using curette inside the sulcus by applying pressure on junctional epithelium and supra crestal connective tissue. Photo biomodulation therapy will be applied with diode Laser( by following laser safety protocol like using protective eye shields )in two stages: First Stage: Photo Biomodulation Therapy (Pre-Bleeding) where in the fiber tip of diode laser will be inserted approximately 3-4 mm into the interdental papilla (at the base of the papilla). The laser will be applied to the designated spots around the gingiva. Second Stage: Photo Biomodulation Therapy (Post Bleeding). Again, the fiber tip will be inserted

into the interdental papilla at the base, and laser treatment will be applied to the previously marked areas of the gingiva.  Haemolaser therapy will be done on baseline and after1 week in both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Participants with class I, class II, or class III [Nordland and Tarnow classification] anterior interdental papillary loss.
  • Non-smoker participants.
  • Participants who can maintain good oral hygiene.
  • male and female participants with age group of 18-50 years.
  • 5.The participants who have a healthy periodontal state.

排除标准

  • 1.Participants with any systemic diseases.
  • Consumption of drugs causing gingival hyperplasia.
  • Participants with periodontal pocket and malocclusion.
  • 4.Pregnant and lactating women.
  • Participants who have coagulopathies.
  • 6.Participants who are undergoing orthodontic treatment.

结局指标

主要结局

Anterior Interdental papillary gain.

时间窗: Baseline, 4 weeks and 24 weeks

次要结局

  • Gingival index(Bleeding index)

研究者

发起方
Dr. Maturu Sai Sruthi
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Dr Maturu Sai Sruthi

Narayana Dental College and Hospital

研究点 (1)

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