Clinical trial NCT00955643: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Disease
Keywords: periodontitis
hyperbaric oxygen therapy
Lead sponsor: Escola Bahiana de Medicina e Saude Publica
Sponsor class: OTHER
First posted: 2009-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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®).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: EBMSP Central Clinic
state: Bahia
Study officials:
References: