Periodontal DiseaseHACPNCT02368678
"Study of Halitosis in Patients With Advanced Chronic Periodontitis"
A study testing Scaling and Root Planning (SRP) and Full Mouth Scaling (FMS) in people with Periodontal Disease and Halitosis, run by Federal University of Minas Gerais.
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 Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Periodontal Disease, Halitosis, Periodontitis
- What is being tested?
- Scaling and Root Planning (SRP) and Full Mouth Scaling (FMS)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 35 and 60 years
- presence of at least 20 natural teeth
- diagnosis of chronic periodontitis
- halitosis
- no smokers
Who cannot join
- 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
About this study
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
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
Read the 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.
- Conditions
- Periodontal Disease, Halitosis, Periodontitis
- Being tested
- Scaling and Root Planning (SRP), Full Mouth Scaling (FMS)
- Keywords
- Halitosis, Sulfur compounds, Periodontitis, Periodontal treatment
- Medical subject headings
- Periodontal Diseases, Halitosis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root Planning (SRP)Procedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Scaling and Root Planning (SRP) | Active comparator | 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. Receives: Procedure: Scaling and Root Planning (SRP) |
| Full Mouth Scaling (FMS) | Active comparator | 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. Receives: Procedure: Full Mouth Scaling (FMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Halitosis at 3 months
Reduction in the number of patients with halitosis and improvement regarding halitosis severity
Measured: Baseline and 90 days
Secondary outcomes (1)
Change from baseline in clinical attachment level at 3 months
Gain of clinical attachment levels (mean values)
Measured: Baseline and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startApr 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Oliveira da Silveira, Federal University of Minas Gerais
- Investigators
- Juliana O. da Silveira, Master, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368678
- Sponsor's protocol ID
- K4gnj9dd
- Acronym
- HACP
- Status last verified
- Feb 2015
- First submitted
- 8 Feb 2015
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tanaka M, Yamamoto Y, Kuboniwa M, Nonaka A, Nishida N, Maeda K, Kataoka K, Nagata H, Shizukuishi S. Contribution of periodontal pathogens on tongue dorsa analyzed with real-time PCR to oral malodor. Microbes Infect. 2004 Oct;6(12):1078-83. doi: 10.1016/j.micinf.2004.05.021.
PubMed 15380777Tangerman A, Winkel EG. Intra- and extra-oral halitosis: finding of a new form of extra-oral blood-borne halitosis caused by dimethyl sulphide. J Clin Periodontol. 2007 Sep;34(9):748-55. doi: 10.1111/j.1600-051X.2007.01116.x.
PubMed 17716310Tonzetich J, Carpenter PA. Production of volatile sulphur compounds from cysteine, cystine and methionine by human dental plague. Arch Oral Biol. 1971 Jun;16(6):599-607. doi: 10.1016/0003-9969(71)90063-x. No abstract available.
PubMed 5283484Bollen CM, Beikler T. Halitosis: the multidisciplinary approach. Int J Oral Sci. 2012 Jun;4(2):55-63. doi: 10.1038/ijos.2012.39.
PubMed 22722640Awano S, Gohara K, Kurihara E, Ansai T, Takehara T. The relationship between the presence of periodontopathogenic bacteria in saliva and halitosis. Int Dent J. 2002 Jun;52 Suppl 3:212-6. doi: 10.1002/j.1875-595x.2002.tb00927.x.
PubMed 12090455Awano S, Koshimune S, Kurihara E, Gohara K, Sakai A, Soh I, Hamasaki T, Ansai T, Takehara T. The assessment of methyl mercaptan, an important clinical marker for the diagnosis of oral malodor. J Dent. 2004 Sep;32(7):555-9. doi: 10.1016/j.jdent.2004.06.001.
PubMed 15386861Bosy A, Kulkarni GV, Rosenberg M, McCulloch CA. Relationship of oral malodor to periodontitis: evidence of independence in discrete subpopulations. J Periodontol. 1994 Jan;65(1):37-46. doi: 10.1902/jop.1994.65.1.37.
PubMed 8133414Bosy A. Oral malodor: philosophical and practical aspects. J Can Dent Assoc. 1997 Mar;63(3):196-201.
PubMed 9086681Bornstein MM, Kislig K, Hoti BB, Seemann R, Lussi A. Prevalence of halitosis in the population of the city of Bern, Switzerland: a study comparing self-reported and clinical data. Eur J Oral Sci. 2009 Jun;117(3):261-7. doi: 10.1111/j.1600-0722.2009.00630.x.
PubMed 19583753Coil JM, Yaegaki K, Matsuo T, Miyazaki H. Treatment needs (TN) and practical remedies for halitosis. Int Dent J. 2002 Jun;52 Suppl 3:187-91. doi: 10.1002/j.1875-595x.2002.tb00922.x.
PubMed 12090450De Boever EH, Loesche WJ. Assessing the contribution of anaerobic microflora of the tongue to oral malodor. J Am Dent Assoc. 1995 Oct;126(10):1384-93. doi: 10.14219/jada.archive.1995.0049.
PubMed 7594010Faveri M, Hayacibara MF, Pupio GC, Cury JA, Tsuzuki CO, Hayacibara RM. A cross-over study on the effect of various therapeutic approaches to morning breath odour. J Clin Periodontol. 2006 Aug;33(8):555-60. doi: 10.1111/j.1600-051X.2006.00955.x.
PubMed 16899098Figueiredo LC, Rosetti EP, Marcantonio E Jr, Marcantonio RA, Salvador SL. The relationship of oral malodor in patients with or without periodontal disease. J Periodontol. 2002 Nov;73(11):1338-42. doi: 10.1902/jop.2002.73.11.1338.
PubMed 12479639Furne J, Majerus G, Lenton P, Springfield J, Levitt DG, Levitt MD. Comparison of volatile sulfur compound concentrations measured with a sulfide detector vs. gas chromatography. J Dent Res. 2002 Feb;81(2):140-3.
PubMed 11827259Goldberg S, Kozlovsky A, Gordon D, Gelernter I, Sintov A, Rosenberg M. Cadaverine as a putative component of oral malodor. J Dent Res. 1994 Jun;73(6):1168-72. doi: 10.1177/00220345940730060701.
PubMed 8046106
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02368678
- Acronym / sponsor ID
- HACP / K4gnj9dd
- Conditions
- Periodontal Disease, Halitosis, Periodontitis
- Keywords
- Halitosis, Sulfur compounds, Periodontitis, Periodontal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scaling and Root Planning (SRP) | Active comparator | Procedure: 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) | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age between 35 and 60 years
- presence of at least 20 natural teeth
- diagnosis of chronic periodontitis
- halitosis
- no smokers
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Scaling and Root Planning (SRP) |
| 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. | Procedure or surgery | Full Mouth Scaling (FMS) |
Primary outcome
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
1 secondary outcome
Change from baseline in clinical attachment level at 3 months
Time frame: Baseline and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- Background: PubMed 15380777Tanaka M, Yamamoto Y, Kuboniwa M, Nonaka A, Nishida N, Maeda K, Kataoka K, Nagata H, Shizukuishi S. Contribution of periodontal pathogens on tongue dorsa analyzed with real-time PCR to oral malodor. Microbes Infect. 2004 Oct;6(12):1078-83. doi: 10.1016/j.micinf.2004.05.021.
- Background: PubMed 17716310Tangerman A, Winkel EG. Intra- and extra-oral halitosis: finding of a new form of extra-oral blood-borne halitosis caused by dimethyl sulphide. J Clin Periodontol. 2007 Sep;34(9):748-55. doi: 10.1111/j.1600-051X.2007.01116.x.
- Background: PubMed 5283484Tonzetich J, Carpenter PA. Production of volatile sulphur compounds from cysteine, cystine and methionine by human dental plague. Arch Oral Biol. 1971 Jun;16(6):599-607. doi: 10.1016/0003-9969(71)90063-x. No abstract available.
- Results publication: PubMed 22722640Bollen CM, Beikler T. Halitosis: the multidisciplinary approach. Int J Oral Sci. 2012 Jun;4(2):55-63. doi: 10.1038/ijos.2012.39.
- Results publication: PubMed 12090455Awano S, Gohara K, Kurihara E, Ansai T, Takehara T. The relationship between the presence of periodontopathogenic bacteria in saliva and halitosis. Int Dent J. 2002 Jun;52 Suppl 3:212-6. doi: 10.1002/j.1875-595x.2002.tb00927.x.
- Results publication: PubMed 15386861Awano S, Koshimune S, Kurihara E, Gohara K, Sakai A, Soh I, Hamasaki T, Ansai T, Takehara T. The assessment of methyl mercaptan, an important clinical marker for the diagnosis of oral malodor. J Dent. 2004 Sep;32(7):555-9. doi: 10.1016/j.jdent.2004.06.001.
- Results publication: PubMed 8133414Bosy A, Kulkarni GV, Rosenberg M, McCulloch CA. Relationship of oral malodor to periodontitis: evidence of independence in discrete subpopulations. J Periodontol. 1994 Jan;65(1):37-46. doi: 10.1902/jop.1994.65.1.37.
- Results publication: PubMed 9086681Bosy A. Oral malodor: philosophical and practical aspects. J Can Dent Assoc. 1997 Mar;63(3):196-201.
- Results publication: PubMed 19583753Bornstein MM, Kislig K, Hoti BB, Seemann R, Lussi A. Prevalence of halitosis in the population of the city of Bern, Switzerland: a study comparing self-reported and clinical data. Eur J Oral Sci. 2009 Jun;117(3):261-7. doi: 10.1111/j.1600-0722.2009.00630.x.
- Results publication: PubMed 12090450Coil JM, Yaegaki K, Matsuo T, Miyazaki H. Treatment needs (TN) and practical remedies for halitosis. Int Dent J. 2002 Jun;52 Suppl 3:187-91. doi: 10.1002/j.1875-595x.2002.tb00922.x.
- Results publication: PubMed 7594010De Boever EH, Loesche WJ. Assessing the contribution of anaerobic microflora of the tongue to oral malodor. J Am Dent Assoc. 1995 Oct;126(10):1384-93. doi: 10.14219/jada.archive.1995.0049.
- Results publication: PubMed 16899098Faveri M, Hayacibara MF, Pupio GC, Cury JA, Tsuzuki CO, Hayacibara RM. A cross-over study on the effect of various therapeutic approaches to morning breath odour. J Clin Periodontol. 2006 Aug;33(8):555-60. doi: 10.1111/j.1600-051X.2006.00955.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana O. da Silveira, Master principal investigator
Federal University of Minas Gerais
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and Root Planning (SRP) and Full Mouth Scaling (FMS) in people with Periodontal Disease and Halitosis, run by Federal University of Minas Gerais.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Halitosis at 3 months (time frame: Baseline and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02368678, which also lists 54 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.