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临床试验/CTRI/2024/09/074503
CTRI/2024/09/074503已完成4 期

Effect of ozonated aloe vera gel application as an adjunctive to scaling and root planing in the treatment of stage II grade a periodontitis patients

Pedapudi Divya1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Clinical attachment level (CAL) gain

研究概览

简要总结

Periodontitis is the  chronic  inflammation of the periodontium that extends beyond the gingiva and involves the destruction of the tooth supporting tissues. Gingivitis as the early stage of this disease may turn into more severe periodontitis characterized by pocket formation, alveolar bone destruction, and loss of clinical attachment level. The first treatment goal in periodontal disease is  changing or removing microbial origin and risk factors to prevent disease progression and maintain periodontal tissue health. Various host-response modulation therapies and local drug therapies have been developed to block the pathways responsible for periodontal tissue break down . Since bacterial products, immunological and inflammatory factors are involved in the pathogenesis of periodontal disease, some products as adjunctive therapy can be used to help the healing process or controlling bacterial infection. Currently, ozone therapy is gaining popularity as a modern non-invasive method of treatment , it is a powerful oxidizing agent with a high antimicrobial power against oral pathogens. Due to the fewer side effects of medicinal herbs, some studies showed green tea, Cordiaverbenacea (a native plant of Brazil coasts) and Mikanialaevigata, per se or in combination with SRP, can be beneficial in periodontitis treatment.  Aloe vera is a cactus-like plant of Liliaceae family with about 360 species containing 75 active ingredients such as vitamins, enzymes, minerals, sugars, lignins, saponins, salicylic acids, and amino acids. Bhat et al examined the clinical effects of aloe vera gel during periodontal surgeries in patients with periodontal disease after mechanical debridement, reporting that topical aloe vera gel improved periodontal status; therefore, it can be used as a topical drug in periodontal pockets. Taking into considerations  of effectiveness of aloe vera and ozone The present study was planned to observe the clincal outcomes with placement Ozonated alovera gel as an  adjunctive to scaling and root planing( SRP). At initial visit, clinical examination will be performed on each patient and all the clinical parameters will be recorded.  Patients who met the inclusion criteria are randomly divided into Group I and Group II. All the patients will receive Phase 1 therapy followed by non surgical periodontal therapy. Patients in group I will receive ozonated aloe vera gel application along with non surgical periodontal therapy where as group II patients will receive Non Ozonated aloe vera gel application with non surgical periodontal therapy.Patients were instructed not to eat, drink, or rinse for at least 30 min and refrain from chewing hard or sticky foods, brushing near the gel treated site or using inter-dental aids. All clinical parameters are recorded at 30 and 60 days visit. Reinforcement of oral hygiene instructions at each appointment will be done.

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 and Outcome Assessor Blinded

入排标准

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

入选标准

  • Subjects with Stage II Grade A periodontitis.
  • Subjects who are apparently healthy.

排除标准

  • Pregnant women and lactating mothers.
  • Allergic drug history .
  • Subjects who are under antibiotic therapy.

结局指标

主要结局

Clinical attachment level (CAL) gain

时间窗: Baseline, 1 month, 2 months

次要结局

  • Plaque index(Gingival index)

研究者

发起方
Pedapudi Divya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DrPedapudi Divya

SIBAR INSTITUTE OF DENTAL SCIENCES

研究点 (1)

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