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Completed

NCT Number: NCT02368678

"Study of Halitosis in Patients With Advanced Chronic Periodontitis"

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

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Key information

Conditions

Periodontal Disease Halitosis Mouth Diseases Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Signs and Symptoms Signs and Symptoms, Digestive Stomatognathic Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scaling and Root Planning (SRP)

Procedure

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 (FMS)

Procedure

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 outcomes

  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 outcomes

  1. Change from baseline in clinical attachment level at 3 months

    Time frame: Baseline and 90 days

    Gain of clinical attachment levels (mean values)

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Acronym: HACP

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 23, 2015
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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