- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00955643
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)
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bahia
-
Salvador, Bahia, Brazil, 40000
- EBMSP Central Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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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