Periodontal Treatment Associated With Hyperbaric Oxygen Therapy

Periodontal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955643
• Other study ID #: HBOT900208-06
• Status: Completed
• Phase: N/A
• First received: August 7, 2009
• Last updated: August 7, 2009
• Start date: March 2002
• Est. completion date: April 2003

Study information

• Verified date: August 2009
• Source: Escola Bahiana de Medicina e Saude Publica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Other:
• oxygen

• other

Locations

Country	Name	City	State
Brazil	EBMSP Central Clinic	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Escola Bahiana de Medicina e Saude Publica

Country where clinical trial is conducted

Brazil,