"Study of Halitosis in Patients With Advanced Chronic Periodontitis"

Periodontitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368678
• Other study ID #: K4gnj9dd
• Status: Completed
• Phase: N/A
• First received: February 8, 2015
• Last updated: February 20, 2015
• Start date: April 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Gingival Diseases
• Halitosis
• Periodontal Disease
• Periodontal Diseases
• Periodontitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

References & Publications (54)

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* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Halitosis at 3 months	Reduction in the number of patients with halitosis and improvement regarding halitosis severity	Baseline and 90 days	No
Secondary	Change from baseline in clinical attachment level at 3 months	Gain of clinical attachment levels (mean values)	Baseline and 90 days	No