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"Study of Halitosis in Patients With Advanced Chronic Periodontitis" (HACP)

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ClinicalTrials.gov Identifier: NCT02368678
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Juliana Oliveira da Silveira, Federal University of Minas Gerais

Study Description
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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

Condition or disease Intervention/treatment Phase
Periodontal Disease Halitosis Periodontitis Procedure: Scaling and Root Planning (SRP) Procedure: Full Mouth Scaling (FMS) Not Applicable

Detailed Description:
In recent years, several studies have shown that the levels of volatile sulfur compounds are higher in periodontitis patients. However, the relationship between periodontal disease and bad breath is still controversial. Aspects that should be clarified include its relation to periodontitis severity, the influence of risk variables and the subject of the present research, that is treatment choice. To help clinicians and patients when deciding about mechanical periodontal therapy, 30 patients with advanced chronic periodontitis were selected from the periodontics clinic, Dental School, Pontiphical Catholic University of Minas Gerais from April 2013 to May 2014. A complete periodontal clinical examination was performed and the following parameters were recorded: probing depth (PD), clinical attachment level (CAL), bleeding on probing, plaque index, and tongue coating index. Halitosis was assessed by using the organoleptic method and measurements of volatile sulfur compounds (VSC), including hydrogen sulfide (H2S) and methyl mercaptan (CH3SH) by using gas chromatography, at baseline and 90 days after non-surgical periodontal treatment. After periodontal clinical examination, individuals were randomly allocated to full-mouth scaling (FMS) - completed within 24 hours - or to conventional quadrant-wise scaling and root planing (SRP) - completed within 2 months. Halitosis and sulfur gas levels were were statistically compared (Mann-Whitney and Wilcoxon tests, p < 0.05). For inter- and intra-group comparisons regarding categorical variables Chi-square, McNemar, and Fisher exact tests were used. Primary outcome was halitosis changing.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect Off Full Mouth Disinfection And Scaling Root Planing Per Quadrant In Halitosis in Patients With Advanced Chronic Periodontitis: Randomized Controlled Clinical Trial
Study Start Date : April 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Scaling and Root Planning (SRP)
Scaling 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.
 Procedure: Scaling and Root Planning (SRP)

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.
Active Comparator: Full Mouth Scaling (FMS)
Full 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.
 Procedure: Full Mouth Scaling (FMS)

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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in Halitosis at 3 months [ Time Frame: Baseline and 90 days ]
    Reduction in the number of patients with halitosis and improvement regarding halitosis severity


Secondary Outcome Measures :
  1. Change from baseline in clinical attachment level at 3 months [ Time Frame: Baseline and 90 days ]
    Gain of clinical attachment levels (mean values)


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 35 and 60 years
  • presence of at least 20 natural teeth
  • diagnosis of chronic periodontitis
  • halitosis
  • no smokers

Exclusion Criteria:

  • 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368678


Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
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Principal Investigator: Juliana O. da Silveira, Master Federal University of Minas Gerais
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Juliana Oliveira da Silveira, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02368678    
Other Study ID Numbers: K4gnj9dd
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015
Keywords provided by Juliana Oliveira da Silveira, Federal University of Minas Gerais:
Halitosis
Sulfur compounds
Periodontitis
Periodontal treatment
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Halitosis
 Mouth Diseases
Stomatognathic Diseases
Signs and Symptoms, Digestive