"Study of Halitosis in Patients With Advanced Chronic Periodontitis"
HACP
Effect Off Full Mouth Disinfection And Scaling Root Planing Per Quadrant In Halitosis in Patients With Advanced Chronic Periodontitis: Randomized Controlled Clinical Trial
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
The objective of this study was to evaluate whether short-term full mouth disinfection protocol could have a greater reduction in the levels of halitosis and volatile sulfur compound or not, when compared to quadrant-wise scaling and root planing
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
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
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 8, 2015
CompletedFirst Posted
Study publicly available on registry
February 23, 2015
CompletedFebruary 23, 2015
February 1, 2015
1.1 years
February 8, 2015
February 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Halitosis at 3 months
Reduction in the number of patients with halitosis and improvement regarding halitosis severity
Baseline and 90 days
Secondary Outcomes (1)
Change from baseline in clinical attachment level at 3 months
Baseline and 90 days
Study Arms (2)
Scaling and Root Planning (SRP)
ACTIVE COMPARATORScaling and root planing (SRP) (n=15): the traditional mechanical periodontal therapy consisting of quadrant-wise (30 min. per quadrant) scaling and root planning performed at weekly sessions (one or two weeks of interval between session) and completed within 2 months.
Full Mouth Scaling (FMS)
ACTIVE COMPARATORFull mouth scaling (FMS) (n=15): the alternative mechanical periodontal therapy consisting of full-mouth scaling and root planning completed in a single stage within 24 hours; i.e two sessions (60 min. per session) in two consecutive days.
Interventions
Scaling and Root Planing (n=15): quadrant-wise scaling and root planing performed within four weekly session (30 min. per quadrant). Oral malodor was measured by organoleptic test and Oral Chroma (Abilit, Osaka Japan) prior to the oral examination, at Baseline and also at 90 days after treatment. Clinical monitoring and tongue coating index were taken at these same times. Oral hygiene instructions were given to all participants.
Full Mouth Scaling (n=15): scaling and root planning was performed in a single stage (within 24 hours); two sessions (60 min. per session) in two consecutive days. Oral malodor was measured by organoleptic test and Oral Chroma (Abilit, Osaka Japan) prior to the oral examination, at Baseline and also at 90 days after treatment. Clinical monitoring and tongue coating index were taken at these same times. Oral hygiene instructions were given to all participants.
Eligibility Criteria
You may qualify if:
- age between 35 and 60 years
- presence of at least 20 natural teeth
- diagnosis of chronic periodontitis
- halitosis
- no smokers
You may not qualify if:
- smokers or former smokers
- individuals diagnosed with diabetes and / or immunological disorders
- pregnant or lactating / patients with removable partial dentures and / or fixed or removable orthodontic appliance
- systemic use of antibiotics or anti-inflammatory in the last six months
- need for prophylactic use of antibiotics for performing the treatment
- regular use or use in the last six months of any kind of mouthwash
- individuals who underwent periodontal treatment in the 6 months preceding the start of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (54)
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PMID: 17716310BACKGROUNDTonzetich J, Carpenter PA. Production of volatile sulphur compounds from cysteine, cystine and methionine by human dental plague. Arch Oral Biol. 1971 Jun;16(6):599-607. doi: 10.1016/0003-9969(71)90063-x. No abstract available.
PMID: 5283484BACKGROUNDBollen CM, Beikler T. Halitosis: the multidisciplinary approach. Int J Oral Sci. 2012 Jun;4(2):55-63. doi: 10.1038/ijos.2012.39.
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PMID: 11210077RESULTNadanovsky P, Carvalho LB, Ponce de Leon A. Oral malodour and its association with age and sex in a general population in Brazil. Oral Dis. 2007 Jan;13(1):105-9. doi: 10.1111/j.1601-0825.2006.01257.x.
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PMID: 12694427RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliana O. da Silveira, Master
Federal University of Minas Gerais
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Juliana Oliveira da Silveira
Study Record Dates
First Submitted
February 8, 2015
First Posted
February 23, 2015
Study Start
April 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
February 23, 2015
Record last verified: 2015-02