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临床试验/NCT06994455
NCT06994455进行中(未招募)不适用

Efficacy of Local Doxycycline Gel Delivery Versus Doxycycline Nanoparticles Prepared Gel in The Treatment of Stage II Periodontitis

Mansoura University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
45
试验地点
2
主要终点
probing pocket depth reduction

研究概览

简要总结

To evaluate the Efficacy of Local Doxycycline Gel Delivery Versus Doxycycline Nanoparticles Prepared Gel in The Treatment of stage II Periodontitis

Materials and methods: forty five patients (n=45) were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University. 45 particpants are classified into 3 groups

Group 1(test group): 15 Patients will be treated with doxycycline gel (regular non-nanoparticle form) as an adjunct to mechanical debridement.

Group 2 (test group): 15 Patients will be treated with doxycycline-loaded Poly lactic-co-glycolic acid (PLGA) nanoparticles gel as an adjunct to mechanical debridement.

Group 3 (control group): 15 patients will be treated with mechanical debridement only.

After proper examination and diagnosis, full mouth supra- and subgingival scaling and root planning will be performed over two weeks (two consecutive days per week) and all periodontitis patients will be treated with ultrasonic scaler and hand instrument for meticulous removal of subgingival and supragingival plaque and calculus. All patients will receive oral hygiene instructions.

Gel Application:

After completion of scaling and root planning the doxycycline gel will be injected subgingivally in the deepest selected periodontitis pockets of the group 1 and doxycycline-loaded Poly lactic-co-glycolic acid (PLGA) gel in group 2 using a disposable syringe.

Care will be taken to apply the gel without traumatizing or damaging the periodontal tissues. Participants will be instructed to refrain from chewing hard or consuming sticky foods, brushing near the treated areas, or using any interdental aids for 1 week. The injection will be applied in the third week with maintenance of good oral hygiene.

Periodontal Parameters:

Changes in the clinical parameters will be evaluated. For all periodontitis patients, the Clinical assessment will be performed at baseline, after 4 weeks and after 8 weeks from the start of the study.

All these clinical parameters will be assessed:

  1. Plaque Index according to Silness & Loe 1964.26
  2. Gingival Bleeding Index according to Ainamo & Bay 1975.27
  3. Probing pocket depth (PPD) 28 is measured from free gingival margin to the base of the pocket.
  4. Clinical attachment level (CAL) 29 is measured from the cement-enamel junction to the base of the pocket.

Microbiological assessment:

Subgingival plaque sample collection will be done for semi-quantitative measuring of P.gingivalis and P.intermedia. Each periodontal site included in the study will be isolated with cotton rolls and dried with an air syringe to avoid contamination with saliva. Before sample collection, all clinically detected supragingival plaque are remove with a sterile curette to avoid contamination between supragingival and subgingival plaque. The subgingival plaque samples are collected by insertion of sterile medium size paper point into the pocket for 30 seconds. Samples with any saliva or blood contamination are discard. After that, the paper point is immediately store in a sterile microcentrifuge tube containing 1 ml of thioglycolate broth transport media and send immediately to microbial diagnostic and infection control unit (MDICU) for sample processing. Samples are culture anaerobically for detection of total bacterial count as well as p.gingivalis and p.intermedia count.

详细描述

Inclusion criteria: The selected patients included:

Patients of both sexes above 20 years old Patients with probing pocket depth ≤ 5 mm. No history of antibiotic and periodontal therapy in the last 3 months.

Exclusion criteria included:

Patients with systemic diseases. Pregnant and lactating females. Heavy smokers.

Gel Application:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes above 20 years old
  • Patients with probing pocket depth ≤ 5 mm.
  • No history of antibiotic and periodontal therapy in the last 3 months

排除标准

  • Patients with systemic diseases.
  • Pregnant and lactating females.
  • Heavy smokers.

结局指标

主要结局

probing pocket depth reduction

时间窗: 8 weeks

pocket depth is calculated using periodontal probe to calculate the distance between the base of the pocket to the free gingival margin

次要结局

  • plaque index(8 weeks)
  • clinical attachment gain(8 weeks)
  • gingival bleeding index(8 weeks)
  • microbiological detection of p.gingivalis(8 weeks)
  • microbiological detection for p.intermedia(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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