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

Primary Purpose

Periodontal Disease, Halitosis, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scaling and Root Planning (SRP)
Full Mouth Scaling (FMS)
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Disease focused on measuring Halitosis, Sulfur compounds, Periodontitis, Periodontal treatment

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Scaling and Root Planning (SRP)

    Full Mouth Scaling (FMS)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change from baseline in Halitosis at 3 months
    Reduction in the number of patients with halitosis and improvement regarding halitosis severity

    Secondary Outcome Measures

    Change from baseline in clinical attachment level at 3 months
    Gain of clinical attachment levels (mean values)

    Full Information

    First Posted
    February 8, 2015
    Last Updated
    February 20, 2015
    Sponsor
    Federal University of Minas Gerais
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02368678
    Brief Title
    "Study of Halitosis in Patients With Advanced Chronic Periodontitis"
    Acronym
    HACP
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Minas Gerais

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Disease, Halitosis, Periodontitis
    Keywords
    Halitosis, Sulfur compounds, Periodontitis, Periodontal treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Scaling and Root Planning (SRP)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Full Mouth Scaling (FMS)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Scaling and Root Planning (SRP)
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Full Mouth Scaling (FMS)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from baseline in Halitosis at 3 months
    Description
    Reduction in the number of patients with halitosis and improvement regarding halitosis severity
    Time Frame
    Baseline and 90 days
    Secondary Outcome Measure Information:
    Title
    Change from baseline in clinical attachment level at 3 months
    Description
    Gain of clinical attachment levels (mean values)
    Time Frame
    Baseline and 90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juliana O. da Silveira, Master
    Organizational Affiliation
    Federal University of Minas Gerais
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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