NCT00955643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2009

Completed
Last Updated

August 10, 2009

Status Verified

August 1, 2009

First QC Date

August 7, 2009

Last Update Submit

August 7, 2009

Conditions

Periodontal Disease

Keywords

periodontitishyperbaric oxygen therapy

Study Arms (2)

hyperbaric therapy

EXPERIMENTAL

Hyperbaric therapy by oxygen

Other: oxygen

dental scaling and root planing

EXPERIMENTAL

dental scaling and cleaning

Other: other

Interventions

oxygenOTHER
hyperbaric therapy
otherOTHER
dental scaling and root planing

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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®)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EBMSP Central Clinic

Salvador, Estado de Bahia, 40000, Brazil

Location

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2009

First Posted

August 10, 2009

Study Start

March 1, 2002

Study Completion

April 1, 2003

Last Updated

August 10, 2009

Record last verified: 2009-08

Locations

BR(1)