Periodontal Treatment Associated With Hyperbaric Oxygen Therapy

NCT ID: NCT00955643

Last Updated: 2009-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2003-04-30

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.

Conditions

Periodontal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

hyperbaric therapy

Hyperbaric therapy by oxygen

Group Type: EXPERIMENTAL

oxygen

Intervention Type: OTHER

dental scaling and root planing

dental scaling and cleaning

Group Type: EXPERIMENTAL

other

Intervention Type: OTHER

Interventions

oxygen

Intervention Type: OTHER

other

Intervention Type: OTHER

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
• 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®).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Escola Bahiana de Medicina e Saude Publica

OTHER

Sponsor Role: lead

Responsible Party

Bahiana

Locations

EBMSP Central Clinic

Salvador, Estado de Bahia, Brazil

Countries

Brazil

Other Identifiers

HBOT900208-06

Identifier Type: -

Identifier Source: org_study_id