"Study of Halitosis in Patients With Advanced Chronic Periodontitis"

Not Applicable

Completed

• Conditions: Periodontal Disease; Halitosis; Periodontitis
• Interventions: Procedure: Scaling and Root Planning (SRP); Procedure: Full Mouth Scaling (FMS)

• Registration Number: NCT02368678
• Lead Sponsor: Federal University of Minas Gerais

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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-02
• Study First Submitted: 2015-02-08
• Study First Submitted QC: 2015-02-20
• Last Update Submitted: 2015-02-20
• Study First Posted: 2015-02-23
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaling and Root Planning (SRP)	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.
Full Mouth Scaling (FMS)	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Halitosis at 3 months	Baseline and 90 days	Reduction in the number of patients with halitosis and improvement regarding halitosis severity

Secondary Outcome Measures

Name	Time	Method
Change from baseline in clinical attachment level at 3 months	Baseline and 90 days	Gain of clinical attachment levels (mean values)