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Periodontal Treatment Associated With Hyperbaric Oxygen Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00955643
First Posted: August 10, 2009
Last Update Posted: August 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Escola Bahiana de Medicina e Saude Publica
  Purpose
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.

Condition Intervention
Periodontal Disease Other: oxygen Other: other

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Periodontal Therapy in Severe Cases of Periodontitis: Preliminary Findings of Non-surgical Instrumentation With or Without Hyperbaric Oxygen Therapy (HBOT)

Resource links provided by NLM:


Further study details as provided by Escola Bahiana de Medicina e Saude Publica:

Enrollment: 20
Study Start Date: March 2002
Study Completion Date: April 2003
Arms Assigned Interventions
Experimental: hyperbaric therapy
Hyperbaric therapy by oxygen
Other: oxygen
Experimental: dental scaling and root planing
dental scaling and cleaning
Other: other

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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®).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955643


Locations
Brazil
EBMSP Central Clinic
Salvador, Bahia, Brazil, 40000
Sponsors and Collaborators
Escola Bahiana de Medicina e Saude Publica
  More Information

Responsible Party: EBMSP, Bahiana
ClinicalTrials.gov Identifier: NCT00955643     History of Changes
Other Study ID Numbers: HBOT900208-06
First Submitted: August 7, 2009
First Posted: August 10, 2009
Last Update Posted: August 10, 2009
Last Verified: August 2009

Keywords provided by Escola Bahiana de Medicina e Saude Publica:
periodontitis
hyperbaric oxygen therapy

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases