ObeseROPDNCT02508415
Relationship Between Obesity and Periodontal Disease
A study testing Non Surgical Periodontal Therapy in people with Obese and Periodontal Disease, run by University of Malaya at 1 site in Malaysia.
Trial summary
Obesity is an epidemic with increasing prevalence in the Asia Pacific region. The first Malaysian national estimate in 1996 of obesity was 5.8%. A systematic review reported a marked increase in obesity in 2003, 2004 and 2006 with 12.2%, 12.3% and 14.0% respectively. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obese, Periodontal Disease
- What is being tested?
- Non Surgical Periodontal Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteMalaysia
- Study dates
- Feb 2013to Jan 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese i.e. BMI ≥ 30 kg/m2 (WHO 1997)
- Age should be ≥ 30 years old
- Patients should have at least 12 teeth present
Who cannot join
- Non Malaysian subjects
- Patients who have received periodontal treatment within the past 4 months
- Patients who have been on antibiotics within the past 4 months
- Patients who require prophylactic antibiotic coverage
- Patients who have been on systemic or topical steroidal anti-inflammatory drugs for the past 4 months
- Patients who are pregnant and lactating mothers
- Patients who are mentally handicapped that may interfere with oral hygiene procedures
Trial locations and contacts
1 site in 1 country.
About this study
Obesity is an epidemic with increasing prevalence in the Asia Pacific region. The first Malaysian national estimate in 1996 of obesity was 5.8%. A systematic review reported a marked increase in obesity in 2003, 2004 and 2006 with 12.2%, 12.3% and 14.0% respectively.
Periodontal disease is a chronic inflammatory disease which results in gingival inflammation, irreversible attachment loss, alveolar bone destruction and eventually tooth loss. Worldwide, the prevalence of periodontitis in the adult population is about 10-15%. Periodontal disease, through inflammation and destruction of the periodontium produces clinical signs and symptoms, some of which may have a considerable impact on quality of life (QoL).
Read more
A positive association between obesity and periodontal disease was repeatedly demonstrated worldwide. Obese individuals have elevated levels of circulating TNF- α and IL-6 compared to normal weight individuals. These cytokines decrease after weight loss. Adipokines produced by adipose tissue could be one of the mechanisms mediating the association between obesity and periodontal disease. This suggests that obesity may have the potential to modify the host's immunity and inflammatory system.
This project will extend the existing information on the association between obesity and periodontal disease including QoL aspect to a Malaysia population. It will also improve knowledge on the cellular and molecular mechanisms that underpin obesity-periodontal disease relationship. By extension, this study also will cast light on the effects of periodontal interventions for the subgroup population.
Read the detailed description
Obesity is an epidemic with increasing prevalence in most countries in the Asia Pacific region. It is characterized by abnormal or excessive lipid deposition as a result of chronic disproportion between energy intake and energy outflow. The first Malaysian national estimate in 1996 of obesity was 5.8%. A systematic review reported a marked increase in obesity in 1996, 2003, 2004 and 2006 with 5.5%, 12.2%, 12.3% and 14.0%. Obesity is highest among adults of 40-59 years old, is greater risk in women compared to men and is highest among Indians followed by Malays, Chinese and Aboriginals.
Periodontitis and obesity are both chronic health problems, and an association between the two conditions exists. A positive association was repeatedly demonstrated between obesity and periodontal disease in multiple studies around the world.
Periodontal disease is a chronic oral infection, in which destruction of tooth supporting structures, periodontal ligament and alveolar bone occurs, leading ultimately to tooth loss. Worldwide, the prevalence of periodontitis in the adult population is about 10-15%. In Malaysia, the National Oral Health study reported 90.2% of the adults presented with some forms of periodontal conditions. About 5.5% of these subjects had deep pockets of 6 mm or more.
Periodontal disease, through inflammation and destruction of the periodontium produces a wide range of clinical signs and symptoms, some of which may have a considerable impact on quality of life (QoL). A study conducted using a community sample found a significant association between periodontal disease and quality of life (QoL). They also found that self-reported symptoms of periodontal diseases such as swollen gums, sore gums and receding gums has an apparent impact on the quality of life of the person. With the mechanism of obesity, it is expected that the obese patients may have experienced more severe periodontal diseases and hence they may experience more impact on the quality of life. However, the evidence is still lacking.
Cytokines play a role in the pathogenesis of periodontitis. They play an active role in wound repair and in transient inflammation. They also activate defence mechanisms in which they may give rise to considerable tissue damage in severe inflammation.
Adipose tissue cells namely adipocytes, preadipocytes and macrophages secrete protein signals collectively known as adipokines or adipocytokines. Adipokines are involved in inflammation and the acute-phase response. Production of adipokines increased in obesity, and raised circulating levels of several acute-phase proteins and inflammatory cytokines. This has led to the concept that obese is a state of chronic low-grade systemic inflammation causally link to insulin resistance and metabolic syndrome.
Salivary components comprising of several inflammatory and immune mediators have been identified which are involved in periodontal destruction. Among all the adipokines, resistin which is an adipocyte-derived cytokine is raised in obese mice. In humans, it is suggested that resistin is largely expressed from neutrophils, macrophages, and monocytes other than adipocytes. Resistin is identified as a proinflammatory adipokine that potentially links obesity to diabetes. It is also believed that human resistin stimulates the production and secretion of other proinflammatory molecules like tumor necrosis factor (TNF)-α and interleukin (IL)-12. Studies have shown high levels of resistin in subjects having chronic periodontitis and this may affect systemic health. In a study by Devanoorkar et al., stated that the decrease in the resistin levels was not statistically significant following non-surgical periodontal therapy.
The reason for the interest in GCF/serum levels of resistin in periodontitis lies in the fact that epidemiological research indicates that periodontitis interplays between obesity and diabetes mellitus. It is possible that raised levels of resistin in periodontitis can explain at least in part the link between periodontitis and other chronic inflammatory diseases. Therefore, the overall aim of this systematic review was to provide evidence of resistin biomarker in chronic periodontal disease which might underpin the relationship between periodontal disease, diabetes and obesity. Evidence from case-control studies are all summarized and evaluated.
- Conditions
- Obese, Periodontal Disease
- Being tested
- Non Surgical Periodontal Therapy
- Keywords
- obesity, periodontal disease, intervention
- Medical subject headings
- Obesity, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Surgical Periodontal TherapyOther
OHE, scaling root planing, mouth wash
| Study group | Role | What they receive |
|---|---|---|
| Non Surgical Periodontal Therapy | Experimental | Will receive oral hygiene education, scaling and root planing. OHE includes brushing and flossing techniques, chlorhexidine mouth rinse twice a day Receives: Other: Non Surgical Periodontal Therapy |
| No Non Surgical Periodontal Therapy | No intervention | No treatment received |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in clinical attachment levels (CAL) (mean CAL in mm, as a measure for periodontal parameters) following non surgical periodontal therapy
Measured: baseline to 12 weeks
Secondary outcomes (2)
Oral health related quality of life (OHRQoL)
Measured: baseline to 12 weeks
salivary resistin (measured in ng/ml)
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startFeb 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nor Adinar Baharuddin, DClinDent, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508415
- Sponsor's protocol ID
- UMalaya
- Acronym
- ROPD
- Status last verified
- Jul 2015
- First submitted
- 2 Apr 2015
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Price RA, Reed DR, Guido NJ. Resemblance for body mass index in families of obese African American and European American women. Obes Res. 2000 Aug;8(5):360-6. doi: 10.1038/oby.2000.43.
PubMed 10968727Asia Pacific Cohort Studies Collaboration. The burden of overweight and obesity in the Asia-Pacific region. Obes Rev. 2007 May;8(3):191-6. doi: 10.1111/j.1467-789X.2006.00292.x.
PubMed 17444961Khambalia AZ, Seen LS. Trends in overweight and obese adults in Malaysia (1996-2009): a systematic review. Obes Rev. 2010 Jun;11(6):403-12. doi: 10.1111/j.1467-789X.2010.00728.x. Epub 2010 Mar 11.
PubMed 20233309Kussmann M, Raymond F, Affolter M. OMICS-driven biomarker discovery in nutrition and health. J Biotechnol. 2006 Aug 5;124(4):758-87. doi: 10.1016/j.jbiotec.2006.02.014. Epub 2006 Apr 4.
PubMed 16600411Suvan J, D'Aiuto F, Moles DR, Petrie A, Donos N. Association between overweight/obesity and periodontitis in adults. A systematic review. Obes Rev. 2011 May;12(5):e381-404. doi: 10.1111/j.1467-789X.2010.00808.x. Epub 2011 Feb 23.
PubMed 21348914Chaffee BW, Weston SJ. Association between chronic periodontal disease and obesity: a systematic review and meta-analysis. J Periodontol. 2010 Dec;81(12):1708-24. doi: 10.1902/jop.2010.100321. Epub 2010 Aug 19.
PubMed 20722533Page RC. The role of inflammatory mediators in the pathogenesis of periodontal disease. J Periodontal Res. 1991 May;26(3 Pt 2):230-42. doi: 10.1111/j.1600-0765.1991.tb01649.x.
PubMed 1679130Yudkin JS, Stehouwer CD, Emeis JJ, Coppack SW. C-reactive protein in healthy subjects: associations with obesity, insulin resistance, and endothelial dysfunction: a potential role for cytokines originating from adipose tissue? Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):972-8. doi: 10.1161/01.atv.19.4.972.
PubMed 10195925Steppan CM, Bailey ST, Bhat S, Brown EJ, Banerjee RR, Wright CM, Patel HR, Ahima RS, Lazar MA. The hormone resistin links obesity to diabetes. Nature. 2001 Jan 18;409(6818):307-12. doi: 10.1038/35053000.
PubMed 11201732Hiroshima Y, Bando M, Inagaki Y, Mihara C, Kataoka M, Murata H, Shinohara Y, Nagata T, Kido J. Resistin in gingival crevicular fluid and induction of resistin release by Porphyromonas gingivalis lipopolysaccharide in human neutrophils. J Periodontal Res. 2012 Oct;47(5):554-62. doi: 10.1111/j.1600-0765.2011.01466.x. Epub 2012 Feb 6.
PubMed 22309231Devanoorkar A, Dwarakanath CD, Gundanavar G, Kathariya R, Patil SR. Evaluation of serum resistin levels in periodontal health and disease and effects of non surgical periodontal therapy on its levels. Dis Markers. 2012;32(5):289-94. doi: 10.1155/2012/153418.
PubMed 22848926Basher SS, Saub R, Vaithilingam RD, Safii SH, Daher AM, Al-Bayaty FH, Baharuddin NA. Impact of non-surgical periodontal therapy on OHRQoL in an obese population, a randomised control trial. Health Qual Life Outcomes. 2017 Nov 21;15(1):225. doi: 10.1186/s12955-017-0793-7.
PubMed 29157276
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Obesity and Periodontal Disease
- ClinicalTrials.gov ID
- NCT02508415
- Acronym / sponsor ID
- ROPD / UMalaya
- Conditions
- Obese, Periodontal Disease
- Keywords
- obesity, periodontal disease, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Jul 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.
Obesity is an epidemic with increasing prevalence in the Asia Pacific region. The first Malaysian national estimate in 1996 of obesity was 5.8%. A systematic review reported a marked increase in obesity in 2003, 2004 and 2006 with 12.2%, 12.3% and 14.0% respectively.
Periodontal disease is a chronic inflammatory disease which results in gingival inflammation, irreversible attachment loss, alveolar bone destruction and eventually tooth loss. Worldwide, the prevalence of periodontitis in the adult population is about 10-15%. Periodontal disease, through inflammation and destruction of the periodontium produces clinical signs and symptoms, some of which may have a considerable impact on quality of life (QoL).
A positive association between obesity and periodontal disease was repeatedly demonstrated worldwide. Obese individuals have elevated levels of circulating TNF- α and IL-6 compared to normal weight individuals. These cytokines decrease after weight loss. Adipokines produced by adipose tissue could be one of the mechanisms mediating the association between obesity and periodontal disease. This suggests that obesity may have the potential to modify the host's immunity and inflammatory system.
This project will extend the existing information on the association between obesity and periodontal disease including QoL aspect to a Malaysia population. It will also improve knowledge on the cellular and molecular mechanisms that underpin obesity-periodontal disease relationship. By extension, this study also will cast light on the effects of periodontal interventions for the subgroup population.
Detailed description
Obesity is an epidemic with increasing prevalence in most countries in the Asia Pacific region. It is characterized by abnormal or excessive lipid deposition as a result of chronic disproportion between energy intake and energy outflow. The first Malaysian national estimate in 1996 of obesity was 5.8%. A systematic review reported a marked increase in obesity in 1996, 2003, 2004 and 2006 with 5.5%, 12.2%, 12.3% and 14.0%. Obesity is highest among adults of 40-59 years old, is greater risk in women compared to men and is highest among Indians followed by Malays, Chinese and Aboriginals.
Periodontitis and obesity are both chronic health problems, and an association between the two conditions exists. A positive association was repeatedly demonstrated between obesity and periodontal disease in multiple studies around the world.
Periodontal disease is a chronic oral infection, in which destruction of tooth supporting structures, periodontal ligament and alveolar bone occurs, leading ultimately to tooth loss. Worldwide, the prevalence of periodontitis in the adult population is about 10-15%. In Malaysia, the National Oral Health study reported 90.2% of the adults presented with some forms of periodontal conditions. About 5.5% of these subjects had deep pockets of 6 mm or more.
Periodontal disease, through inflammation and destruction of the periodontium produces a wide range of clinical signs and symptoms, some of which may have a considerable impact on quality of life (QoL). A study conducted using a community sample found a significant association between periodontal disease and quality of life (QoL). They also found that self-reported symptoms of periodontal diseases such as swollen gums, sore gums and receding gums has an apparent impact on the quality of life of the person. With the mechanism of obesity, it is expected that the obese patients may have experienced more severe periodontal diseases and hence they may experience more impact on the quality of life. However, the evidence is still lacking.
Cytokines play a role in the pathogenesis of periodontitis. They play an active role in wound repair and in transient inflammation. They also activate defence mechanisms in which they may give rise to considerable tissue damage in severe inflammation.
Adipose tissue cells namely adipocytes, preadipocytes and macrophages secrete protein signals collectively known as adipokines or adipocytokines. Adipokines are involved in inflammation and the acute-phase response. Production of adipokines increased in obesity, and raised circulating levels of several acute-phase proteins and inflammatory cytokines. This has led to the concept that obese is a state of chronic low-grade systemic inflammation causally link to insulin resistance and metabolic syndrome.
Salivary components comprising of several inflammatory and immune mediators have been identified which are involved in periodontal destruction. Among all the adipokines, resistin which is an adipocyte-derived cytokine is raised in obese mice. In humans, it is suggested that resistin is largely expressed from neutrophils, macrophages, and monocytes other than adipocytes. Resistin is identified as a proinflammatory adipokine that potentially links obesity to diabetes. It is also believed that human resistin stimulates the production and secretion of other proinflammatory molecules like tumor necrosis factor (TNF)-α and interleukin (IL)-12. Studies have shown high levels of resistin in subjects having chronic periodontitis and this may affect systemic health. In a study by Devanoorkar et al., stated that the decrease in the resistin levels was not statistically significant following non-surgical periodontal therapy.
The reason for the interest in GCF/serum levels of resistin in periodontitis lies in the fact that epidemiological research indicates that periodontitis interplays between obesity and diabetes mellitus. It is possible that raised levels of resistin in periodontitis can explain at least in part the link between periodontitis and other chronic inflammatory diseases. Therefore, the overall aim of this systematic review was to provide evidence of resistin biomarker in chronic periodontal disease which might underpin the relationship between periodontal disease, diabetes and obesity. Evidence from case-control studies are all summarized and evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Surgical Periodontal Therapy | Experimental | Other: Non Surgical Periodontal TherapyWill receive oral hygiene education, scaling and root planing. OHE includes brushing and flossing techniques, chlorhexidine mouth rinse twice a day |
| No Non Surgical Periodontal Therapy | No intervention | –No treatment received |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Obese i.e. BMI ≥ 30 kg/m2 (WHO 1997)
- Age should be ≥ 30 years old
- Patients should have at least 12 teeth present
Key exclusion criteria (7 listed)
- Non Malaysian subjects
- Patients who have received periodontal treatment within the past 4 months
- Patients who have been on antibiotics within the past 4 months
- Patients who require prophylactic antibiotic coverage
- Patients who have been on systemic or topical steroidal anti-inflammatory drugs for the past 4 months
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 |
|---|---|---|
| Non Surgical Periodontal TherapyOHE, scaling root planing, mouth wash | Other | Non Surgical Periodontal Therapy |
Primary outcome
changes in clinical attachment levels (CAL) (mean CAL in mm, as a measure for periodontal parameters) following non surgical periodontal therapy
Time frame: baseline to 12 weeks
2 secondary outcomes
Oral health related quality of life (OHRQoL)
Time frame: baseline to 12 weeks
salivary resistin (measured in ng/ml)
Time frame: baseline to 12 weeks
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 27 Jul 2015.
- Background: PubMed 10968727Price RA, Reed DR, Guido NJ. Resemblance for body mass index in families of obese African American and European American women. Obes Res. 2000 Aug;8(5):360-6. doi: 10.1038/oby.2000.43.
- Background: PubMed 17444961Asia Pacific Cohort Studies Collaboration. The burden of overweight and obesity in the Asia-Pacific region. Obes Rev. 2007 May;8(3):191-6. doi: 10.1111/j.1467-789X.2006.00292.x.
- Background: PubMed 20233309Khambalia AZ, Seen LS. Trends in overweight and obese adults in Malaysia (1996-2009): a systematic review. Obes Rev. 2010 Jun;11(6):403-12. doi: 10.1111/j.1467-789X.2010.00728.x. Epub 2010 Mar 11.
- Background: PubMed 16600411Kussmann M, Raymond F, Affolter M. OMICS-driven biomarker discovery in nutrition and health. J Biotechnol. 2006 Aug 5;124(4):758-87. doi: 10.1016/j.jbiotec.2006.02.014. Epub 2006 Apr 4.
- Background: PubMed 21348914Suvan J, D'Aiuto F, Moles DR, Petrie A, Donos N. Association between overweight/obesity and periodontitis in adults. A systematic review. Obes Rev. 2011 May;12(5):e381-404. doi: 10.1111/j.1467-789X.2010.00808.x. Epub 2011 Feb 23.
- Background: PubMed 20722533Chaffee BW, Weston SJ. Association between chronic periodontal disease and obesity: a systematic review and meta-analysis. J Periodontol. 2010 Dec;81(12):1708-24. doi: 10.1902/jop.2010.100321. Epub 2010 Aug 19.
- Background: PubMed 1679130Page RC. The role of inflammatory mediators in the pathogenesis of periodontal disease. J Periodontal Res. 1991 May;26(3 Pt 2):230-42. doi: 10.1111/j.1600-0765.1991.tb01649.x.
- Background: PubMed 10195925Yudkin JS, Stehouwer CD, Emeis JJ, Coppack SW. C-reactive protein in healthy subjects: associations with obesity, insulin resistance, and endothelial dysfunction: a potential role for cytokines originating from adipose tissue? Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):972-8. doi: 10.1161/01.atv.19.4.972.
- Background: PubMed 11201732Steppan CM, Bailey ST, Bhat S, Brown EJ, Banerjee RR, Wright CM, Patel HR, Ahima RS, Lazar MA. The hormone resistin links obesity to diabetes. Nature. 2001 Jan 18;409(6818):307-12. doi: 10.1038/35053000.
- Background: PubMed 22309231Hiroshima Y, Bando M, Inagaki Y, Mihara C, Kataoka M, Murata H, Shinohara Y, Nagata T, Kido J. Resistin in gingival crevicular fluid and induction of resistin release by Porphyromonas gingivalis lipopolysaccharide in human neutrophils. J Periodontal Res. 2012 Oct;47(5):554-62. doi: 10.1111/j.1600-0765.2011.01466.x. Epub 2012 Feb 6.
- Background: PubMed 22848926Devanoorkar A, Dwarakanath CD, Gundanavar G, Kathariya R, Patil SR. Evaluation of serum resistin levels in periodontal health and disease and effects of non surgical periodontal therapy on its levels. Dis Markers. 2012;32(5):289-94. doi: 10.1155/2012/153418.
- Derived from this study: PubMed 29157276Basher SS, Saub R, Vaithilingam RD, Safii SH, Daher AM, Al-Bayaty FH, Baharuddin NA. Impact of non-surgical periodontal therapy on OHRQoL in an obese population, a randomised control trial. Health Qual Life Outcomes. 2017 Nov 21;15(1):225. doi: 10.1186/s12955-017-0793-7.
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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.
Nor Adinar Baharuddin, DClinDent principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Surgical Periodontal Therapy in people with Obese and Periodontal Disease, run by University of Malaya at 1 site in Malaysia.
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 3 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 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
changes in clinical attachment levels (CAL) (mean CAL in mm, as a measure for periodontal parameters) following non surgical periodontal therapy (time frame: baseline to 12 weeks). 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 NCT02508415, which also lists 12 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 27 Jul 2015.