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临床试验/CTRI/2025/07/090645
CTRI/2025/07/090645尚未招募2 期

Comparative evaluation of clinical efficacy of Origanum oil, Magnolia oil, Cranberry oil and Tea tree oil oral in-situ gels as local drug delivery in the treatment of Stage -I and Stage-II Periodontitis

Dr Boyapati Ramanarayana1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月20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
80
试验地点
1
主要终点
1. Improvement in clinical attachment level

研究概览

简要总结

Periodontal disease is a significant global public health concern affecting individuals across all demographics. It encompasses inflammatory conditions like gingivitis and periodontitis, with the latter leading to irreversible damage such as alveolar bone resorption and periodontal ligament detachment. The disease is primarily initiated by gram-negative bacterial colonization, which stimulates a destructive host immune response through the release of pro-inflammatory mediators like IL-1 and PGE2.

Traditional treatment through scaling and root planing (SRP) helps reduce microbial load but is limited in accessing deeper periodontal pockets. Although systemic antibiotics are effective, they pose risks such as antibiotic resistance and secondary infections. To overcome these limitations, localized drug delivery systems have gained attention, offering targeted treatment with fewer systemic side effects. However, many synthetic agents still cause undesirable effects like gastrointestinal distress and tooth staining.

As a result, attention has shifted to phytotherapy, which explores natural plant-based agents with antimicrobial and anti-inflammatory properties. Several herbal compounds have demonstrated potential in periodontal therapy. Carvacrol, derived from Origanum vulgare, exhibits antibacterial, anti-inflammatory, and antioxidant properties. Magnolol, a bioactive compound from Magnolia officinalis, shows diverse pharmacological benefits including antibacterial and anti-inflammatory actions. Cranberry extracts, particularly rich in proanthocyanidins, hinder bacterial adhesion and proteolytic activity of key periodontopathogens. Tea tree oil, containing active constituents like 1,8-cineole and terpinen-4-ol, demonstrates antimicrobial efficacy comparable to chlorhexidine with a different mechanism of action and better biocompatibility.

Given these promising properties, the present study proposes to evaluate and compare the clinical efficacy of in situ oral gels formulated from Carvacrol (Origanum vulgare oil), Magnolol (Magnolia officinalis oil), Vaccinium macrocarpon (cranberry) oil, and Tea Tree Oil as adjuncts to SRP in managing Stage-1 and Stage-2 periodontitis. These natural alternatives may offer effective periodontal therapy with fewer adverse effects.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
30.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with Stage I and Stage II Periodontitis.
  • 2.Patients within the age group of 30 to 55 years of age for both genders.
  • 3.Subjects with no history of allergies to the components used in the study 4.Apparently healthy individuals 5.Patients who are willing to give consent.

排除标准

  • 1.Patients with habits like any form of tobacco, or alcohol consumption.
  • 2.Systemically compromised patients 3.Pregnant women or lactating mothers 4.Patients who are on medication that influences Periodontal health.
  • 5.Patients who will not be able to be attend for follow up visits.

结局指标

主要结局

1. Improvement in clinical attachment level

时间窗: baseline,1 month and 3 months

2.Reduction of Periodontal Pocket Probing Depth

时间窗: baseline,1 month and 3 months

次要结局

  • better wound healing (PISA index)(baseline,1 month and 3 months)

研究者

发起方
Dr Boyapati Ramanarayana
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Boyapati Ramanarayana

SIBAR INSTITUTE OF DENTAL SCIENCES

研究点 (1)

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