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Periodontal Treatment Associated With Hyperbaric Oxygen Therapy

Primary Purpose

Periodontal Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
oxygen
other
Sponsored by
Escola Bahiana de Medicina e Saude Publica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Disease focused on measuring periodontitis, hyperbaric oxygen therapy

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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®).

Sites / Locations

  • EBMSP Central Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

hyperbaric therapy

dental scaling and root planing

Arm Description

Hyperbaric therapy by oxygen

dental scaling and cleaning

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 7, 2009
Last Updated
August 7, 2009
Sponsor
Escola Bahiana de Medicina e Saude Publica
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1. Study Identification

Unique Protocol Identification Number
NCT00955643
Brief Title
Periodontal Treatment Associated With Hyperbaric Oxygen Therapy
Official Title
Periodontal Therapy in Severe Cases of Periodontitis: Preliminary Findings of Non-surgical Instrumentation With or Without Hyperbaric Oxygen Therapy (HBOT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Escola Bahiana de Medicina e Saude Publica

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
Keywords
periodontitis, hyperbaric oxygen therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hyperbaric therapy
Arm Type
Experimental
Arm Description
Hyperbaric therapy by oxygen
Arm Title
dental scaling and root planing
Arm Type
Experimental
Arm Description
dental scaling and cleaning
Intervention Type
Other
Intervention Name(s)
oxygen
Intervention Type
Other
Intervention Name(s)
other

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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®).
Facility Information:
Facility Name
EBMSP Central Clinic
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40000
Country
Brazil

12. IPD Sharing Statement

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Periodontal Treatment Associated With Hyperbaric Oxygen Therapy

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