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临床试验/NCT00955643
NCT00955643已完成不适用

Periodontal Therapy in Severe Cases of Periodontitis: Preliminary Findings of Non-surgical Instrumentation With or Without Hyperbaric Oxygen Therapy (HBOT)

Escola Bahiana de Medicina e Saude Publica2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2002年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2

研究概览

简要总结

Evaluation of the clinical effect of hyperbaric oxygen therapy (HBOT) adjunctively to scaling and root planing (SRP) in the treatment of severe case of chronic periodontitis.

详细描述

Materials and Methods

In 20 patients diagnosed with severe generalized chronic periodontitis (pockets>7mm) with bleeding on probing, SRP was rendered in all pockets. Additionally, five consecutive hyperbaric sessions were administered in 10 patients after random allocation (SRP+HBOT). Clinical parameters were assessed at baseline up to 6 months: plaque index (PI), bleeding on probing, probing depth, clinical attachment level and BANA test.

Results: SRP+HBOT resulted in greater probing reduction and attachment gain than SRP alone 3 months after treatment (p<0.001). The BANA test was negative after 1 week only for sites in the SRP+HBOT group (p<0.05). However SRP+HBOT failed to show a significant difference from SRP group after 3 months were all BANA sites became negative (p>0.05).

Conclusion: These preliminary data suggest that hyperbaric oxygen therapy had a short-term beneficial effect on pocket reduction and bacterial elimination, and may be considered a potential therapy option to improve the clinical outcomes of scaling in severe cases of chronic periodontitis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • This preliminary (pilot) study was designed with twenty subjects (12 men, 8 women, mean age 37.3 years) selected from a pool of 360 patients referred to the Periodontal Clinic of the School of Dentistry at Bahian Science Foundation (FBDC, Bahia, Brazil).
  • The patients had an initial diagnosis of severe generalized chronic periodontitis (AAP 1999).

排除标准

  • Patients were excluded according to the following criteria:
  • pregnancy or lactation
  • antibiotics or periodontal treatment within the last 6 months
  • a diagnosis of aggressive periodontitis
  • trauma from occlusion or endodontic lesions
  • According to an accurate clinical examination performed by a hyperbaric medical doctor (MD), the HBOT contra-indications (Iazzeti & Mantovani 1998) served as exclusion criteria.
  • The only absolute contraindication to hyperbaric oxygen therapy was from patients with untreated pneumothorax
  • Relative contraindications were considered:
  • upper respiratory infections
  • high fevers
  • emphysema with CO2 retention
  • historic of thoracic surgery
  • malignant disease and middle ear barotrauma
  • Patients taking or have recently taken the following drugs:
  • doxorubicin (Adriamycin®)
  • disulfiram (Antabuse®)
  • Cis-platinum and mafenide acetate (Sulfamylon®).

研究者

发起方
Escola Bahiana de Medicina e Saude Publica
申办方类型
Other

研究点 (2)

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