ObeseEONSPTNCT02618486
The Effects of Obesity on Non Surgical Periodontal Therapy
A study testing Non surgical periodontal therapy in people with Obese and Periodontal Disease, run by University of Malaya.
Trial summary
The investigators' earlier study reported a high prevalence of chronic periodontitis among obese Malaysian adult population. Non-surgical periodontal therapy (NSPT) has been shown to effectively reduce microbial load and contributes to reduction in periodontal parameters and inflammatory burden up to 6 months… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy 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, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who are obese
- Those whose age are 30 years and above
- Those who have at least 12 teeth present
Who cannot join
- Those who have received periodontal treatment within the last 4 months
- Those who have been on antibiotics within the past 4 months
- Those who require prophylactic antibiotic coverage, on systemic or topical steroidal anti-inflammatory drugs for the past 4 months,
- Those who are pregnant or intend to be pregnant
- Those lactating mothers, mentally handicapped
About this study
The investigators' earlier study reported a high prevalence of chronic periodontitis among obese Malaysian adult population. Non-surgical periodontal therapy (NSPT) has been shown to effectively reduce microbial load and contributes to reduction in periodontal parameters and inflammatory burden up to 6 months post-therapy. This study will cast light on the effects of obesity on chronic periodontitis (CP) patients following NSPT. The objectives of the study were to quantify and to compare the periodontal pathogens, serum and salivary interleukins in obese and non obese with CP following NSPT.
Read the detailed description
Obesity is a health concern, associated with complex diseases such as diabetes, hypertension as well as chronic periodontitis. The prevalence is estimated as 24% worldwide, 3% for South East Asia, and 27.2% for Malaysia. Prevalence of CP is increasing, with 10-15% reported in various adult populations and estimated 5-20% categorised as severe CP. In Malaysia, the prevalence of severe CP is estimated as 18%.
The first paper on the relationship between obesity and periodontal disease reported that obese-hypertensive rats are more likely to have periodontal tissue deterioration than normal rats. Subsequent study reported an induction of expression of Tumour Necrosis Factor (TNF) -a gene in obese mice and thus proposed TNF-α represents a key mediator of obesity-linked insulin resistance. This was strongly supported by an extension study on human adipose tissue. A model was proposed linking inflammation to obesity, diabetes, and periodontal infection in 2005. Subsequent studies found association between obesity and increased risk for CP in the United States, Japanese and Jordanian adult populations.
Adipose tissue produces a number of adipokines linked to inflammation, including adiponectin, interleukin (IL)-1β, IL-6, TNF-α, Monocyte Chemoattractant Protein (MCP)-1 and Macrophages Migrant Inhibitory Factor (MIF). Increased in circulating levels of pro-inflammatory cytokines such as TNF-α and IL-6 are strongly correlated with obesity, insulin resistance, hyperglycemia and diabetes mellitus. These cytokines also stimulate the synthesis of C-reactive protein (CRP) and fibrinogen by liver, as CRP is known for its role in inflammation, atherosclerosis and insulin resistance. In addition, these cytokines are also secreted from adipose tissues are involved in the pathophysiology of both obesity and periodontitis. Obese individuals have higher levels of circulating TNF-α and IL-6 when compared to normal weight individuals. This may increase the risk of destructive periodontal diseases development. Interestingly, studies on the immune response to periodontal pathogens showed that TNF-α enhanced the immune response to these pathogens.
Periodontal health is accomplished through non-surgical periodontal therapy (NSPT), which includes oral hygiene education (OHE) and scaling and root planing (SRP). NSPT has been reported to effectively reduce microbial load and contributes to reduction in periodontal parameters and inflammatory burden up to 6 months post-therapy. In a general population, NSPT has been shown to induce a shift from a pre-dominant gram-negative to a gram-positive subgingival microbiota. The total bacteria count and positives sites of Porphyromonas gingivalis (P gingivalis) and Tannerella forsythia (T forsythia) were significant decreased in treated group compared to control groups. In addition, SRP has markedly reduced these periodontal pathogens: Porphyromonas gingivalis, Tannerella forsythia as well as Prevotella intermedia 24 months post NSPT.
Molecular mechanisms between inflammatory cytokines and CP are unclear and warrant further studies to determine whether pro-inflammatory cytokines is the pathogenic factor linking obesity to periodontal infections. To date, there are not many studies that examine the changes in periodontal pathogen, salivary and serum interleukins levels in obese patients with CP following NSPT. Further prospective studies are needed to address this issue and to determine stronger evidence on the association between obesity, periodontal diseases and potential mediating factors following NSPT.
- Conditions
- Obese, Periodontal Disease
- Being tested
- Non surgical periodontal therapy
- 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 therapyProcedure or surgery
Also called NSPT
NSPT includes oral hygiene education, scaling root planing and mouth wash
| Study group | Role | What they receive |
|---|---|---|
| Obese with CP | Experimental | Procedure/Surgery Non surgical periodontal therapy Received OHE, scaling and root planing. OHE includes brushing and flossing techniques, chlorhexidine rinse thrice a day Receives: Procedure: Non surgical periodontal therapy |
| Non obese with CP | Active comparator | Procedure/Surgery Non surgical periodontal therapy Received OHE, scaling and root planing. OHE includes brushing and flossing techniques, chlorhexidine rinse thrice a day Receives: Procedure: Non surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in clinical attachment level (CAL) (mean in mm, as a measure of periodontal parameter) in obese and non obese, with chronic periodontitis following NSPT
Measured: 12 weeks
Secondary outcomes (3)
Changes in microbial profile (mean count of Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia and Actinobacillus actinomycetemcomitans quality and quantity) in obese and non obese, with chronic periodontitis before and after NSPT
Measured: 12 weeks
Changes in serum interleukins levels (mean value in ng/mL, of TNF-α, IL-1, IL-6 and resistin) in obese and non obese, with chronic periodontitis before and after NSPT
Measured: 12 weeks
Changes in salivary interleukins levels (mean value in ng/mL, of TNF-α, IL-1, IL-6 and resistin) in obese and non obese, with chronic periodontitis before and after NSPT
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 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, Faculty of Dentistry University of Malaya Kuala Lumpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618486
- Sponsor's protocol ID
- 101269-1
- Acronym
- EONSPT
- Status last verified
- Nov 2015
- First submitted
- 3 Nov 2015
- Last updated
- 1 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khan S, Saub R, Vaithilingam RD, Safii SH, Vethakkan SR, Baharuddin NA. Prevalence of chronic periodontitis in an obese population: a preliminary study. BMC Oral Health. 2015 Sep 29;15:114. doi: 10.1186/s12903-015-0098-3.
PubMed 26419358Albandar JM, Tinoco EM. Global epidemiology of periodontal diseases in children and young persons. Periodontol 2000. 2002;29:153-76. doi: 10.1034/j.1600-0757.2002.290108.x. No abstract available.
PubMed 12102707Albandar JM, Brunelle JA, Kingman A. Destructive periodontal disease in adults 30 years of age and older in the United States, 1988-1994. J Periodontol. 1999 Jan;70(1):13-29. doi: 10.1902/jop.1999.70.1.13.
PubMed 10052767Hugoson A, Norderyd O, Slotte C, Thorstensson H. Distribution of periodontal disease in a Swedish adult population 1973, 1983 and 1993. J Clin Periodontol. 1998 Jul;25(7):542-8. doi: 10.1111/j.1600-051x.1998.tb02485.x.
PubMed 9696253Brown LJ, Loe H. Prevalence, extent, severity and progression of periodontal disease. Periodontol 2000. 1993 Jun;2:57-71. doi: 10.1111/j.1600-0757.1993.tb00220.x. No abstract available.
PubMed 9673181Petersen PE, Bourgeois D, Ogawa H, Estupinan-Day S, Ndiaye C. The global burden of oral diseases and risks to oral health. Bull World Health Organ. 2005 Sep;83(9):661-9. Epub 2005 Sep 30.
PubMed 16211157Brennan DS, Spencer AJ, Roberts-Thomson KF. Quality of life and disability weights associated with periodontal disease. J Dent Res. 2007 Aug;86(8):713-7. doi: 10.1177/154405910708600805.
PubMed 17652197Petersen PE. The World Oral Health Report 2003: continuous improvement of oral health in the 21st century--the approach of the WHO Global Oral Health Programme. Community Dent Oral Epidemiol. 2003 Dec;31 Suppl 1:3-23. doi: 10.1046/j..2003.com122.x.
PubMed 15015736Mohamud WN, Musa KI, Khir AS, Ismail AA, Ismail IS, Kadir KA, Kamaruddin NA, Yaacob NA, Mustafa N, Ali O, Isa SH, Bebakar WM. Prevalence of overweight and obesity among adult Malaysians: an update. Asia Pac J Clin Nutr. 2011;20(1):35-41.
PubMed 21393108Kurukulasuriya LR, Stas S, Lastra G, Manrique C, Sowers JR. Hypertension in obesity. Med Clin North Am. 2011 Sep;95(5):903-17. doi: 10.1016/j.mcna.2011.06.004.
PubMed 21855699Park SH, Park JH, Song PS, Kim DK, Kim KH, Seol SH, Kim HK, Jang HJ, Lee JG, Park HY, Park J, Shin KJ, Kim Di, Moon YS. Sarcopenic obesity as an independent risk factor of hypertension. J Am Soc Hypertens. 2013 Nov-Dec;7(6):420-5. doi: 10.1016/j.jash.2013.06.002. Epub 2013 Jul 30.
PubMed 23910010Marotta T, Russo BF, Ferrara LA. Triglyceride-to-HDL-cholesterol ratio and metabolic syndrome as contributors to cardiovascular risk in overweight patients. Obesity (Silver Spring). 2010 Aug;18(8):1608-13. doi: 10.1038/oby.2009.446. Epub 2009 Dec 17.
PubMed 20019684Matsushita Y, Nakagawa T, Yamamoto S, Kato T, Ouchi T, Kikuchi N, Takahashi Y, Yokoyama T, Mizoue T, Noda M. Adiponectin and visceral fat associate with cardiovascular risk factors. Obesity (Silver Spring). 2014 Jan;22(1):287-91. doi: 10.1002/oby.20425. Epub 2013 Jun 11.
PubMed 23519992Rasmussen F, Hancox RJ. Mechanisms of obesity in asthma. Curr Opin Allergy Clin Immunol. 2014 Feb;14(1):35-43. doi: 10.1097/ACI.0000000000000024.
PubMed 24300417Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
PubMed 17167477
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Obesity on Non Surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT02618486
- Acronym / sponsor ID
- EONSPT / 101269-1
- Conditions
- Obese, Periodontal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Dec 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 investigators' earlier study reported a high prevalence of chronic periodontitis among obese Malaysian adult population. Non-surgical periodontal therapy (NSPT) has been shown to effectively reduce microbial load and contributes to reduction in periodontal parameters and inflammatory burden up to 6 months post-therapy. This study will cast light on the effects of obesity on chronic periodontitis (CP) patients following NSPT. The objectives of the study were to quantify and to compare the periodontal pathogens, serum and salivary interleukins in obese and non obese with CP following NSPT.
Detailed description
Obesity is a health concern, associated with complex diseases such as diabetes, hypertension as well as chronic periodontitis. The prevalence is estimated as 24% worldwide, 3% for South East Asia, and 27.2% for Malaysia. Prevalence of CP is increasing, with 10-15% reported in various adult populations and estimated 5-20% categorised as severe CP. In Malaysia, the prevalence of severe CP is estimated as 18%.
The first paper on the relationship between obesity and periodontal disease reported that obese-hypertensive rats are more likely to have periodontal tissue deterioration than normal rats. Subsequent study reported an induction of expression of Tumour Necrosis Factor (TNF) -a gene in obese mice and thus proposed TNF-α represents a key mediator of obesity-linked insulin resistance. This was strongly supported by an extension study on human adipose tissue. A model was proposed linking inflammation to obesity, diabetes, and periodontal infection in 2005. Subsequent studies found association between obesity and increased risk for CP in the United States, Japanese and Jordanian adult populations.
Adipose tissue produces a number of adipokines linked to inflammation, including adiponectin, interleukin (IL)-1β, IL-6, TNF-α, Monocyte Chemoattractant Protein (MCP)-1 and Macrophages Migrant Inhibitory Factor (MIF). Increased in circulating levels of pro-inflammatory cytokines such as TNF-α and IL-6 are strongly correlated with obesity, insulin resistance, hyperglycemia and diabetes mellitus. These cytokines also stimulate the synthesis of C-reactive protein (CRP) and fibrinogen by liver, as CRP is known for its role in inflammation, atherosclerosis and insulin resistance. In addition, these cytokines are also secreted from adipose tissues are involved in the pathophysiology of both obesity and periodontitis. Obese individuals have higher levels of circulating TNF-α and IL-6 when compared to normal weight individuals. This may increase the risk of destructive periodontal diseases development. Interestingly, studies on the immune response to periodontal pathogens showed that TNF-α enhanced the immune response to these pathogens.
Periodontal health is accomplished through non-surgical periodontal therapy (NSPT), which includes oral hygiene education (OHE) and scaling and root planing (SRP). NSPT has been reported to effectively reduce microbial load and contributes to reduction in periodontal parameters and inflammatory burden up to 6 months post-therapy. In a general population, NSPT has been shown to induce a shift from a pre-dominant gram-negative to a gram-positive subgingival microbiota. The total bacteria count and positives sites of Porphyromonas gingivalis (P gingivalis) and Tannerella forsythia (T forsythia) were significant decreased in treated group compared to control groups. In addition, SRP has markedly reduced these periodontal pathogens: Porphyromonas gingivalis, Tannerella forsythia as well as Prevotella intermedia 24 months post NSPT.
Molecular mechanisms between inflammatory cytokines and CP are unclear and warrant further studies to determine whether pro-inflammatory cytokines is the pathogenic factor linking obesity to periodontal infections. To date, there are not many studies that examine the changes in periodontal pathogen, salivary and serum interleukins levels in obese patients with CP following NSPT. Further prospective studies are needed to address this issue and to determine stronger evidence on the association between obesity, periodontal diseases and potential mediating factors following NSPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese with CP | Experimental | Procedure: Non surgical periodontal therapyProcedure/Surgery Non surgical periodontal therapy Received OHE, scaling and root planing. OHE includes brushing and flossing techniques, chlorhexidine rinse thrice a day |
| Non obese with CP | Active comparator | Procedure: Non surgical periodontal therapyProcedure/Surgery Non surgical periodontal therapy Received OHE, scaling and root planing. OHE includes brushing and flossing techniques, chlorhexidine rinse thrice a day |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those who are obese
- Those whose age are 30 years and above
- Those who have at least 12 teeth present
Key exclusion criteria (5 listed)
- Those who have received periodontal treatment within the last 4 months
- Those who have been on antibiotics within the past 4 months
- Those who require prophylactic antibiotic coverage, on systemic or topical steroidal anti-inflammatory drugs for the past 4 months,
- Those who are pregnant or intend to be pregnant
- Those lactating mothers, mentally handicapped
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 therapyAlso: NSPTNSPT includes oral hygiene education, scaling root planing and mouth wash | Procedure or surgery | Non obese with CP, Obese with CP |
Primary outcome
Changes in clinical attachment level (CAL) (mean in mm, as a measure of periodontal parameter) in obese and non obese, with chronic periodontitis following NSPT
Time frame: 12 weeks
3 secondary outcomes
Changes in microbial profile (mean count of Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia and Actinobacillus actinomycetemcomitans quality and quantity) in obese and non obese, with chronic periodontitis before and after NSPT
Time frame: 12 weeks
Changes in serum interleukins levels (mean value in ng/mL, of TNF-α, IL-1, IL-6 and resistin) in obese and non obese, with chronic periodontitis before and after NSPT
Time frame: 12 weeks
Changes in salivary interleukins levels (mean value in ng/mL, of TNF-α, IL-1, IL-6 and resistin) in obese and non obese, with chronic periodontitis before and after NSPT
Time frame: 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 1 Dec 2015.
- Background: PubMed 26419358Khan S, Saub R, Vaithilingam RD, Safii SH, Vethakkan SR, Baharuddin NA. Prevalence of chronic periodontitis in an obese population: a preliminary study. BMC Oral Health. 2015 Sep 29;15:114. doi: 10.1186/s12903-015-0098-3.
- Background: PubMed 12102707Albandar JM, Tinoco EM. Global epidemiology of periodontal diseases in children and young persons. Periodontol 2000. 2002;29:153-76. doi: 10.1034/j.1600-0757.2002.290108.x. No abstract available.
- Background: PubMed 10052767Albandar JM, Brunelle JA, Kingman A. Destructive periodontal disease in adults 30 years of age and older in the United States, 1988-1994. J Periodontol. 1999 Jan;70(1):13-29. doi: 10.1902/jop.1999.70.1.13.
- Background: PubMed 9696253Hugoson A, Norderyd O, Slotte C, Thorstensson H. Distribution of periodontal disease in a Swedish adult population 1973, 1983 and 1993. J Clin Periodontol. 1998 Jul;25(7):542-8. doi: 10.1111/j.1600-051x.1998.tb02485.x.
- Background: PubMed 9673181Brown LJ, Loe H. Prevalence, extent, severity and progression of periodontal disease. Periodontol 2000. 1993 Jun;2:57-71. doi: 10.1111/j.1600-0757.1993.tb00220.x. No abstract available.
- Background: PubMed 16211157Petersen PE, Bourgeois D, Ogawa H, Estupinan-Day S, Ndiaye C. The global burden of oral diseases and risks to oral health. Bull World Health Organ. 2005 Sep;83(9):661-9. Epub 2005 Sep 30.
- Background: PubMed 17652197Brennan DS, Spencer AJ, Roberts-Thomson KF. Quality of life and disability weights associated with periodontal disease. J Dent Res. 2007 Aug;86(8):713-7. doi: 10.1177/154405910708600805.
- Background: PubMed 15015736Petersen PE. The World Oral Health Report 2003: continuous improvement of oral health in the 21st century--the approach of the WHO Global Oral Health Programme. Community Dent Oral Epidemiol. 2003 Dec;31 Suppl 1:3-23. doi: 10.1046/j..2003.com122.x.
- Background: PubMed 21393108Mohamud WN, Musa KI, Khir AS, Ismail AA, Ismail IS, Kadir KA, Kamaruddin NA, Yaacob NA, Mustafa N, Ali O, Isa SH, Bebakar WM. Prevalence of overweight and obesity among adult Malaysians: an update. Asia Pac J Clin Nutr. 2011;20(1):35-41.
- Background: PubMed 21855699Kurukulasuriya LR, Stas S, Lastra G, Manrique C, Sowers JR. Hypertension in obesity. Med Clin North Am. 2011 Sep;95(5):903-17. doi: 10.1016/j.mcna.2011.06.004.
- Background: PubMed 23910010Park SH, Park JH, Song PS, Kim DK, Kim KH, Seol SH, Kim HK, Jang HJ, Lee JG, Park HY, Park J, Shin KJ, Kim Di, Moon YS. Sarcopenic obesity as an independent risk factor of hypertension. J Am Soc Hypertens. 2013 Nov-Dec;7(6):420-5. doi: 10.1016/j.jash.2013.06.002. Epub 2013 Jul 30.
- Background: PubMed 20019684Marotta T, Russo BF, Ferrara LA. Triglyceride-to-HDL-cholesterol ratio and metabolic syndrome as contributors to cardiovascular risk in overweight patients. Obesity (Silver Spring). 2010 Aug;18(8):1608-13. doi: 10.1038/oby.2009.446. Epub 2009 Dec 17.
Related trials for Obese
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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
Faculty of Dentistry University of Malaya Kuala Lumpur
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.
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 5 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 1 Dec 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?
Changes in clinical attachment level (CAL) (mean in mm, as a measure of periodontal parameter) in obese and non obese, with chronic periodontitis following NSPT (time frame: 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 NCT02618486, which also lists 26 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 1 Dec 2015.