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

February 20, 2015 updated by: Juliana Oliveira da Silveira, Federal University of Minas Gerais

Effect Off Full Mouth Disinfection And Scaling Root Planing Per Quadrant In Halitosis in Patients With Advanced Chronic Periodontitis: Randomized Controlled Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in clinical attachment level at 3 months
Time Frame: Baseline and 90 days
Gain of clinical attachment levels (mean values)
Baseline and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Investigators

  • Principal Investigator: Juliana O. da Silveira, Master, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

February 8, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimate)

February 23, 2015

Study Record Updates

Last Update Posted (Estimate)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 20, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K4gnj9dd

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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