Periodontal Treatment Associated With Hyperbaric Oxygen Therapy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bahia
      • Salvador, Bahia, Brazil, 40000
        • EBMSP Central Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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®).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: hyperbaric therapy
Hyperbaric therapy by oxygen
EXPERIMENTAL: dental scaling and root planing
dental scaling and cleaning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion (ACTUAL)

April 1, 2003

Study Registration Dates

First Submitted

August 7, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (ESTIMATE)

August 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2009

Last Update Submitted That Met QC Criteria

August 7, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • HBOT900208-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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