跳至主要内容
临床试验/CTRI/2025/03/082127
CTRI/2025/03/082127尚未招募不适用

Evaluating the effectiveness of local drug delivery of Multi-berry gel and Tetracycline fibers for the management of periodontitis patients: A randomized control study

Dr Sakshi Romil Shah1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年4月1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
50
试验地点
1
主要终点
Pocket probing depth, Clinical Attachment Level

研究概览

简要总结

Pyorrhoea is an infection that leads to the degradation of the areas around the tooth. Cleaning of the teeth by itself does not eliminate infection, since pyorrhoea reside deeper in the tissue, making them unreachable by instruments, hence different treatments like multi-berry and antibiotics are administered. Systemic antibiotics can cause several side effects like toxicity, development of bacterial resistance, and interactions with other drugs. To address this, a local drug delivery method is employed in gums. Cranberry is a superfruit in many countries including India. The development of two bacterial species, Porphyromonas Gingivalis and Fusobacterium Nucleatum linked to pyorrhoea is suppressed by cranberry extract. This berry also possess anti-bacterial, anti-oxidant and anti-inflammatory properties. Garcinia Cambogia shows strong anti-oxidant and anti-inflammatory effects.Tetracyclines are generally considered to be more effective against Gram-positive bacteria than Gram-negative bacteria and display good activity against most spirochetes as well as many anaerobic and facultative bacteria which is present in pyorrhoea. The other properties of tetracyclines are inhibition of bone resorption, anti-inflammatory actions, and to promote the attachment of fibroblasts and connective tissue to root surfaces and hence it is used in periodontal therapy. Thus, the current research investigates the efficacy of clinical parameters involving multi-berry gel or tetracycline fibers as a local drug delivery for management of periodontitis patients.

研究设计

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

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy patients of both sexes between 30 and 65 years.
  • Having at minimum two teeth with one proximal site with (clinical attachment level [CAL] of 3-4mm, and (probing pocket depth [PPD] of 5-7mm).
  • stage II/III.

排除标准

  • 1.Previous use of systemic or local antibiotic, anti-inflammatory drugs or periodontal therapy in the previous 6 months.
  • 2.Allergic to tetracycline, cranberry and garcinia cambogia 3.Smokers 4.Pregnant/lactating woman .
  • 5.Patients on any medication for systemic diseases like diabetes and hypertension etc.

结局指标

主要结局

Pocket probing depth, Clinical Attachment Level

时间窗: Baseline, 1 month and 3 months

次要结局

  • Sulcus Bleeding Index and Quigley and Hein’s plaque index as modified by Turesky et al.(Baseline, 1 month and 3 months)

研究者

发起方
Dr Sakshi Romil Shah
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sakshi Romil Shah

KM Shah Dental College and Hospital

研究点 (1)

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