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Completed

NCT Number: NCT00955643

Periodontal Treatment Associated With Hyperbaric Oxygen Therapy

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EBMSP Central Clinic

Salvador, Estado de Bahia, 40000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Patients were excluded according to the following criteria:
  • smoking
  • 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®).

Treatment and study plan

Oxygen

Other

other

Other

Sponsors and collaborators

Lead sponsor

Escola Bahiana de Medicina e Saude Publica

Other

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2003
First posted
Aug 10, 2009
Registry last updated
Aug 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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