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临床试验/NCT06404190
NCT06404190已完成1 期

DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN PEROXIDE FOR POCKET DECONTAMINATION A CLINICAL STUDY

Krishnadevaraya College of Dental Sciences & Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年5月28日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Probing pocket Depth

研究概览

简要总结

Routine non surgical periodontal thearpy often fails to achieve complete elimination of pathogenic microorganism. This could be attiributable to deep periodontal pockets, root concavities, furcation involvement etc. Systemic and local antimicrobials have been used adjunctively with scaling and root planning to optimize the results. They have their own draw backs namely antibiotic resistance and narrow spectrum of action over periodontal pathogens. In the last decade lasers applications have diversified occupying greater part of the periodontal treatment strategies. Photodynamic thearpy has shown conflicting results as a adjunctive thearpy. The routinely used dyes are Methyelene blue, indocyanine green and rose bengal .These dyes are difficult to procure and may not be economical . Hydrogen peroxide due to its super radicals has a local antimicrobial effect. Since hydrogen peroxide can be easily available in a clinical setting and is cost effective. It could be used for photodisinfection . From the near-infrared spectrum lasers, the Nd-YAG laser can remove periodontal pathogens because of its thermal effect. However, changes in the neighboring tissues can be attributed to these unwanted thermal effects. The diode lasers that belong to the 655-980 nm spectrum could represent a safer alternative.Because of the transmission or scattering effect on hydroxyapatite, diode lasers have no effect on calculus. Anaerobic bacterial species intermedia produce black pigments in Brucella media from blood agar. Hemoglobin in the soft periodontal tissues behaves like a chromophore, being absorbed by the diode laser. Photoactivated procedure use photolysis of hydrogen peroxide with 810nm laser. It acts as an endogenous dye, which can increase the laser effect at this level and also generate ROS stopped immediately after the laser irridation. Therefore, the diode laser stimulation of 3%hydrogen peroxide has been utilized adjuvantive to SRP to optimize clinical outcome.

详细描述

This study was designed as a randomized controlled single-blind clinical trial to assest the antimicrobial effect of non surgical periodontal thearpy with SRP alone , and photoactivation of 3% H2O2 with 810nm diode in combination with SRP. Based on the method of randomization, each patient was allocated to one of the two treatment groups as follows: Group 1: SRP as monotherapy; Group 2: SRP+H2O2photoactivation with diode laser. One week after the baseline periodontal examination and microbiological sampling, scaling and root planning is carried out using conventional ultrasonic scaler .Every patient received oral hygiene instructions that included modified BASS brushing technique . In Group 1- Only SRP: Group 2- 3% H2O2solution was inserted to the bottom of the periodontal pocket using a disposable plastic needle similar to the endodontic irrigation followed by diode 810 nm laser irridation with 1.1 W, continuous wave (CW) with 300mm The activated fiber was applied from the bottom to the free gingival margin of the periodontal pocket in parallel with the root surface and side-to-side movements were performed for*30 sec per test surface. Microbiological assessment was performed 1 week before periodontal treatment.

Microbiological samples were obtained from the selected periodontal pockets at baseline (before treatment) and at 1 month after the periodontal treatment by the examiner. Sterile paper points will be placed into periodontal pocket to collect the gcf sample for 30 sec, then it is transfer to Eppendorf tubes(individual sampling) having (thioglycate broth) and incubated for 2 hrs then broth is( vortex). Later sample is cultured on the anerobic blood agar media and incubated in gas jar with anerobic gas pack for 48hrs and colony counting is done after 48hrs of incubation. Clinical periodontal parameters PPD, BOP, CAL and mobility were assessed baseine and 3 months after the periodontal treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

盲法说明

GROUP A: 10 SRP ALONE GROUP B: 10 SRP+3%HYDROGEN PEROXIDE+DIODE LASER

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥18 years of age Minimum of 5mm of periodontal probing depth Patient under going orthodontic prosthodontic restorative treatment Stage 2 and 3 Grade B and C periodontitis acc to 2017 classification
  • Exclusive Criteria:
  • Pregnacy systemic disease people

排除标准

  • 未提供

结局指标

主要结局

Probing pocket Depth

时间窗: 3 months

1\. Probing pocket Depth (PPD), dept measuring from cej to depth of pocket through william probe

次要结局

  • DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN-PEROXIDE FOR POCKET DECONTAMINATION - A CLINICAL STUDY(3 month)

研究者

发起方
Krishnadevaraya College of Dental Sciences & Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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