End Stage Renal Failure on DialysisPhase 2NCT01641757
Effect of Non-Surgical Periodontal Therapy on Serum Albumin Levels of Patients on Maintenance Hemodialysis Therapy,
A Phase 2 study testing non-surgical periodontal therapy in people with End Stage Renal Failure on Dialysis and Periodontitis, run by University of the Punjab at 1 site in Pakistan.
Trial summary
Periodontitis is a destructive chronic infection of the gums, ligaments, and bone, predominantly caused by Gram-negative bacteria. Individuals with periodontal disease are at increased risk of systemic diseases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Failure on Dialysis, Periodontitis
- What is being tested?
- non-surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- May 2012to Oct 2012
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic Kidney Disease patients, who are receiving hemodialysis therapy for >3 months. of all ages and both gender and are able to give informed consent.
- Have at least 14 teeth (excluding third molars) in oral cavity shall be included in study.
Who cannot join
- Patients have had periodontal therapy <1 year.
- Diabetes Mellitus
- Liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Non-Surgical Periodontal Therapy on Serum Albumin Levels of Patients on Maintenance Hemodialysis Therapy, A Randomized Control Trial
Periodontitis is a destructive chronic infection of the gums, ligaments, and bone, predominantly caused by Gram-negative bacteria. Individuals with periodontal disease are at increased risk of systemic diseases. Increased prevalence of periodontal disease has been reported in patients with chronic kidney disease, especially in dialysis patients. Chronic kidney disease (CKD) is the progressive loss of kidney function over time. When kidneys loose their 85-90 % function, dialysis is performed. Efficacy of dialysis is checked by serum albumin levels. Lower-than-normal levels of serum albumin may be a sign of kidney diseases. Hypoalbuminemia has been demonstrated to be a strong predictor of death in chronic renal failure. A proposed mechanism for the effect of periodontitis on the development of kidney disease is systemic inflammation. The deleterious effects of systemic inflammation on kidney function could occur during the period of active periodontal infection and accumulate during the life time of the individual. This randomized control trial is designed to observe the effect of non-surgical periodontal therapy on serum albumin levels of patients on maintenance hemodialysis therapy. Patients will undergo periodontal examination and their serum albumin levels will be checked. Then they will be randomly divided in two groups. One group will be given non surgical periodontal treatment and second group will be offered late treatment. After 6 weeks 1st group will be reevaluated by serum albumin level and periodontal examination to observe the effect of non-surgical periodontal therapy. Statistical analyses shall be performed using SPSS software. T tests and Chi-sq tests shall be used to test differences according to periodontal status for continuous and categorical variables, respectively. The level of significance is set at p<0.05.
Read the detailed description
Periodontitis is a destructive chronic infection of the gums, ligaments, and bone, predominantly caused by Gram-negative bacteria residing in biofilm surrounding the teeth. Biofilm is an aggregate of microbes with a distinct architecture. This biofilm contains clusters of bacterial species that are found commonly below the gingiva and are associated reproducibly with periodontal disease. These bacteria involved in periodontitis causes destruction of tissues which leads to formation of a periodontal pocket. This space becomes a site for further bacterial colonization and possible entry route of bacteria in blood stream.
It is evident from the data that periodontal health of the Pakistani nation is very poor with only 28% of the 12 year old having healthy gums and more than 93% of the 65 year old have some gum or periodontal disease . These results indicate that periodontal disease including inflammation of gums and calculus is endemic in Pakistan . Like caries, the level of gingival and periodontal disease is higher in the rural population of the Pakistan.
There is an increasing evidence that individuals with periodontal disease are at increased risk of cardiovascular disease, preterm delivery of low birth weight infants, pulmonary diseases, diabetes, osteoporosis, rheumatoid arthritis, alzheimer's disease \& kidney diseases. The factors predisposing to periodontal disease and accelerating its progression are clearly evident in chronic renal failure. They encompass hyposalivation and xerostomia, impaired immunity and wound healing, alveolar bone destruction due to renal osteodystrophy, bleeding diathesis, diabetes mellitus, malnutrition and a state of general disability impairing oral hygiene. There is evidence for increased prevalence of periodontal disease in patients with renal disease, especially in dialysis patients.
Chronic kidney disease (CKD) is the progressive loss of kidney function over time. Normal renal functions are normally evaluated by glomerular filtration rate (GFR). Normal results range from 90 - 120 mL/min/1.73 m2.
The loss of kidney function usually takes months or years to occur. The final stage of chronic kidney disease is called end-stage renal disease (ESRD) after which kidneys no longer function and the patient needs dialysis or a kidney transplant .
Chronic kidney disease changes the serum levels of Albumin, Potassium, Calcium, Phosphorus, Sodium, Cholesterol and electrolytes. Among all these, albumin is of prime importance because it plays an important role in keeping the fluid from the blood from leaking out into the tissues. The normal range is 3.4 - 5.4 grams per deciliter (g/dL).
Lower-than-normal levels of serum albumin may be a sign of kidney diseases or liver disease (for example, hepatitis, cirrhosis). Decreased albumin may occur when body does not get or absorb enough nutrients, such as after Crohn's disease, Low-protein diets, Sprue, Whipple's disease . Other conditions under which the albumin levels are need to be measured are widespread burns and Wilson,s disease.
Hypoalbuminemia has been demonstrated to be a strong predictor of death in chronic renal failure . Some studies have however suggested that hypoalbuminemia may be more indicative of underlying inflammation, rather than nutritional status, especially in patients with kidney disease. In a study it was observed that on dialysis initiation in the US pediatric population, hypoalbuminemic patients were at higher risk of dying as compared to patients in whom dialysis was initiated with normal albumin levels . It was also assessed that hypoalbuminemia, is highly prevalent in kidney failure and is associated with an increased mortality risk in this population. Serum albumin level may reflect both the nutritional status and chronic inflammation.
A proposed mechanism for the effect of periodontitis on the development of kidney disease is systemic inflammation . Periodontal pathogens have been shown to have the ability to adhere to, invade, and proliferate in coronary endothelial cells leading to atheroma formation and impaired vasculature relaxation. Cardiovascular diseases and CKD share many risk factors, so it is it can be assumed that periodontal disease exerts similar effects within the vasculature of the kidney. Both periodontitis and kidney diseases are associated with inflammatory markers such as C-reactive protein and chronic low level inflammation associated with periodontitis may lead to endothelial dysfunction which plays a role in the pathogenesis of kidney disease in edentulous patients. The deleterious effects of systemic inflammation on kidney function could occur during the period of active periodontal infection and accumulate during the life time of the individual. Inflammation is an important predictor of low serum albumin levels among dialysis patients, independent of nutritional status. Low albumin is often indicative of malnutrition, but chronic inflammation appears to be the culprit in half of the patients with low levels of albumin. This may explain why nutritional therapy does not increase serum albumin levels in some patients suggesting chronic inflammation. High CRP levels correlates with increased mortality, regardless of nutritional status suggesting an independent role for chronic inflammation in causing hypoalbuminemia .
Abhijit V. Kshirsagar et al. observed an association of severe periodontal disease and hypoalbuminemia in a group of patients who were receiving long-term outpatient hemodialysis. In study subjects, patients with periodontal disease were more than three times more likely to have low serum albumin than patients without periodontal disease. Increased levels of plaque have been reported for hemodialysis (HD) populations from several countries including Brazil. It has to be noted, however, that HD patients are also repeatedly exposed to systemic anticoagulation with high-dose heparin during blood purification procedures. This predisposes them further to gingival bleeding and, in consequence, facilitates bacterial colonization and growth, and may propagate periodontal disease. Recently, an impressive 3-fold decrease in C-reactive protein and a rise in hemoglobin (Hb) levels in HD patients were reported to occur already after 4-6 weeks following traditional periodontal therapy . Thus, the issue of poor oral health status in CKD patients apparently deserves a higher awareness of the problem, and increased attention, and indicates the need for a closer collaboration between primary care physicians, nephrologists and dentists.
There is evidence supporting the contribution of periodontitis to systemic inflammation. Several possible mechanisms have been suggested, including the locally produced inflammatory mediators and bacterial by-products that invade the blood stream, interact with host cells and trigger inflammatory response.
A study from Turkey of End Stage Renal disease (ESRD) patients on HD therapy found increased periodontitis as measured by the Community Periodontal Index of Treatment Needs (CPITN). In a study of renal patients receiving HD, Chaung et al, 2005 in Taiwan, reported increased rates of periodontitis when compared with national data on periodontal disease for the Taiwanese population. Studies focusing on the periodontal health of End Stage Renal disease (ESRD) patients on HD maintenance therapy have reported the presence of poor oral hygiene and attendant gingival inflammation.
Bots CP, Poortermann JHG, Brand HS et al (2006) in a study from Netherlands of ESRD patients, some of whom were receiving HD, did not find an increased loss of attachment when compared with some healthy case-matched controls. Periodontal status of End stage Renal Disease (ESRD) patients receiving HD showed no increase in periodontal indices when compared with case-matched controls. The authors did note that the HD group had greater numbers of periodontopathic bacterial species than the control group.
The results of studies conducted so far to establish association between severe periodontitis and hypoalbuminemia are variable and are not conclusive. Only one clinical trial has been conducted regarding that, therefore aim of the study is to observe the effect of non surgical periodontal therapy on changes of albumin levels in maintenance dialysis patients.
- Conditions
- End Stage Renal Failure on Dialysis, Periodontitis
- Being tested
- non-surgical periodontal therapy
- Keywords
- hemodialysis, periodontitis
- Medical subject headings
- Periodontitis
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 dental scaling and root planing
dental scaling and root planing of full mouth will be done
| Study group | Role | What they receive |
|---|---|---|
| periodontal treatment group | Experimental | non surgical periodontal therapy will be given to study subjects which will be selected by randomization from total study sample. at the end of study, serum albumin levels of both study and control groups will be compared. Receives: Procedure: non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum albumin levels
serum albumin levels are considered to be strong predictor of death in dialysis patients. in this trial we want to see the effect of non surgical periodontal therapy on serum albumin levels of patients on maintenance dialysis therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Failure on DialysisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Arsalan Wahid, University of the Punjab
- Investigators
- Ayyaz A Khan, PhD, Study director, Shaikh Zayed Medical CompleX lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641757
- Sponsor's protocol ID
- arsalanmalik
- Status last verified
- Jul 2012
- First submitted
- 10 Jul 2012
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bots CP, Poorterman JH, Brand HS, Kalsbeek H, van Amerongen BM, Veerman EC, Nieuw Amerongen AV. The oral health status of dentate patients with chronic renal failure undergoing dialysis therapy. Oral Dis. 2006 Mar;12(2):176-80. doi: 10.1111/j.1601-0825.2005.01183.x.
PubMed 16476040
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Surgical Periodontal Therapy on Serum Albumin Levels of Patients on Maintenance Hemodialysis Therapy, A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01641757
- Acronym / sponsor ID
- arsalanmalik
- Conditions
- End Stage Renal Failure on Dialysis, Periodontitis
- Keywords
- hemodialysis, periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (estimated)
- First posted
- 17 Jul 2012 (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.
Periodontitis is a destructive chronic infection of the gums, ligaments, and bone, predominantly caused by Gram-negative bacteria. Individuals with periodontal disease are at increased risk of systemic diseases. Increased prevalence of periodontal disease has been reported in patients with chronic kidney disease, especially in dialysis patients. Chronic kidney disease (CKD) is the progressive loss of kidney function over time. When kidneys loose their 85-90 % function, dialysis is performed. Efficacy of dialysis is checked by serum albumin levels. Lower-than-normal levels of serum albumin may be a sign of kidney diseases. Hypoalbuminemia has been demonstrated to be a strong predictor of death in chronic renal failure. A proposed mechanism for the effect of periodontitis on the development of kidney disease is systemic inflammation. The deleterious effects of systemic inflammation on kidney function could occur during the period of active periodontal infection and accumulate during the life time of the individual. This randomized control trial is designed to observe the effect of non-surgical periodontal therapy on serum albumin levels of patients on maintenance hemodialysis therapy. Patients will undergo periodontal examination and their serum albumin levels will be checked. Then they will be randomly divided in two groups. One group will be given non surgical periodontal treatment and second group will be offered late treatment. After 6 weeks 1st group will be reevaluated by serum albumin level and periodontal examination to observe the effect of non-surgical periodontal therapy. Statistical analyses shall be performed using SPSS software. T tests and Chi-sq tests shall be used to test differences according to periodontal status for continuous and categorical variables, respectively. The level of significance is set at p<0.05.
Detailed description
Periodontitis is a destructive chronic infection of the gums, ligaments, and bone, predominantly caused by Gram-negative bacteria residing in biofilm surrounding the teeth. Biofilm is an aggregate of microbes with a distinct architecture. This biofilm contains clusters of bacterial species that are found commonly below the gingiva and are associated reproducibly with periodontal disease. These bacteria involved in periodontitis causes destruction of tissues which leads to formation of a periodontal pocket. This space becomes a site for further bacterial colonization and possible entry route of bacteria in blood stream.
It is evident from the data that periodontal health of the Pakistani nation is very poor with only 28% of the 12 year old having healthy gums and more than 93% of the 65 year old have some gum or periodontal disease . These results indicate that periodontal disease including inflammation of gums and calculus is endemic in Pakistan . Like caries, the level of gingival and periodontal disease is higher in the rural population of the Pakistan.
There is an increasing evidence that individuals with periodontal disease are at increased risk of cardiovascular disease, preterm delivery of low birth weight infants, pulmonary diseases, diabetes, osteoporosis, rheumatoid arthritis, alzheimer's disease \& kidney diseases. The factors predisposing to periodontal disease and accelerating its progression are clearly evident in chronic renal failure. They encompass hyposalivation and xerostomia, impaired immunity and wound healing, alveolar bone destruction due to renal osteodystrophy, bleeding diathesis, diabetes mellitus, malnutrition and a state of general disability impairing oral hygiene. There is evidence for increased prevalence of periodontal disease in patients with renal disease, especially in dialysis patients.
Chronic kidney disease (CKD) is the progressive loss of kidney function over time. Normal renal functions are normally evaluated by glomerular filtration rate (GFR). Normal results range from 90 - 120 mL/min/1.73 m2.
The loss of kidney function usually takes months or years to occur. The final stage of chronic kidney disease is called end-stage renal disease (ESRD) after which kidneys no longer function and the patient needs dialysis or a kidney transplant .
Chronic kidney disease changes the serum levels of Albumin, Potassium, Calcium, Phosphorus, Sodium, Cholesterol and electrolytes. Among all these, albumin is of prime importance because it plays an important role in keeping the fluid from the blood from leaking out into the tissues. The normal range is 3.4 - 5.4 grams per deciliter (g/dL).
Lower-than-normal levels of serum albumin may be a sign of kidney diseases or liver disease (for example, hepatitis, cirrhosis). Decreased albumin may occur when body does not get or absorb enough nutrients, such as after Crohn's disease, Low-protein diets, Sprue, Whipple's disease . Other conditions under which the albumin levels are need to be measured are widespread burns and Wilson,s disease.
Hypoalbuminemia has been demonstrated to be a strong predictor of death in chronic renal failure . Some studies have however suggested that hypoalbuminemia may be more indicative of underlying inflammation, rather than nutritional status, especially in patients with kidney disease. In a study it was observed that on dialysis initiation in the US pediatric population, hypoalbuminemic patients were at higher risk of dying as compared to patients in whom dialysis was initiated with normal albumin levels . It was also assessed that hypoalbuminemia, is highly prevalent in kidney failure and is associated with an increased mortality risk in this population. Serum albumin level may reflect both the nutritional status and chronic inflammation.
A proposed mechanism for the effect of periodontitis on the development of kidney disease is systemic inflammation . Periodontal pathogens have been shown to have the ability to adhere to, invade, and proliferate in coronary endothelial cells leading to atheroma formation and impaired vasculature relaxation. Cardiovascular diseases and CKD share many risk factors, so it is it can be assumed that periodontal disease exerts similar effects within the vasculature of the kidney. Both periodontitis and kidney diseases are associated with inflammatory markers such as C-reactive protein and chronic low level inflammation associated with periodontitis may lead to endothelial dysfunction which plays a role in the pathogenesis of kidney disease in edentulous patients. The deleterious effects of systemic inflammation on kidney function could occur during the period of active periodontal infection and accumulate during the life time of the individual. Inflammation is an important predictor of low serum albumin levels among dialysis patients, independent of nutritional status. Low albumin is often indicative of malnutrition, but chronic inflammation appears to be the culprit in half of the patients with low levels of albumin. This may explain why nutritional therapy does not increase serum albumin levels in some patients suggesting chronic inflammation. High CRP levels correlates with increased mortality, regardless of nutritional status suggesting an independent role for chronic inflammation in causing hypoalbuminemia .
Abhijit V. Kshirsagar et al. observed an association of severe periodontal disease and hypoalbuminemia in a group of patients who were receiving long-term outpatient hemodialysis. In study subjects, patients with periodontal disease were more than three times more likely to have low serum albumin than patients without periodontal disease. Increased levels of plaque have been reported for hemodialysis (HD) populations from several countries including Brazil. It has to be noted, however, that HD patients are also repeatedly exposed to systemic anticoagulation with high-dose heparin during blood purification procedures. This predisposes them further to gingival bleeding and, in consequence, facilitates bacterial colonization and growth, and may propagate periodontal disease. Recently, an impressive 3-fold decrease in C-reactive protein and a rise in hemoglobin (Hb) levels in HD patients were reported to occur already after 4-6 weeks following traditional periodontal therapy . Thus, the issue of poor oral health status in CKD patients apparently deserves a higher awareness of the problem, and increased attention, and indicates the need for a closer collaboration between primary care physicians, nephrologists and dentists.
There is evidence supporting the contribution of periodontitis to systemic inflammation. Several possible mechanisms have been suggested, including the locally produced inflammatory mediators and bacterial by-products that invade the blood stream, interact with host cells and trigger inflammatory response.
A study from Turkey of End Stage Renal disease (ESRD) patients on HD therapy found increased periodontitis as measured by the Community Periodontal Index of Treatment Needs (CPITN). In a study of renal patients receiving HD, Chaung et al, 2005 in Taiwan, reported increased rates of periodontitis when compared with national data on periodontal disease for the Taiwanese population. Studies focusing on the periodontal health of End Stage Renal disease (ESRD) patients on HD maintenance therapy have reported the presence of poor oral hygiene and attendant gingival inflammation.
Bots CP, Poortermann JHG, Brand HS et al (2006) in a study from Netherlands of ESRD patients, some of whom were receiving HD, did not find an increased loss of attachment when compared with some healthy case-matched controls. Periodontal status of End stage Renal Disease (ESRD) patients receiving HD showed no increase in periodontal indices when compared with case-matched controls. The authors did note that the HD group had greater numbers of periodontopathic bacterial species than the control group.
The results of studies conducted so far to establish association between severe periodontitis and hypoalbuminemia are variable and are not conclusive. Only one clinical trial has been conducted regarding that, therefore aim of the study is to observe the effect of non surgical periodontal therapy on changes of albumin levels in maintenance dialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| periodontal treatment group | Experimental | Procedure: non-surgical periodontal therapynon surgical periodontal therapy will be given to study subjects which will be selected by randomization from total study sample. at the end of study, serum albumin levels of both study and control groups will be compared. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic Kidney Disease patients, who are receiving hemodialysis therapy for >3 months. of all ages and both gender and are able to give informed consent.
- Have at least 14 teeth (excluding third molars) in oral cavity shall be included in study.
Key exclusion criteria (3 listed)
- Patients have had periodontal therapy <1 year.
- Diabetes Mellitus
- Liver disease
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: dental scaling and root planingdental scaling and root planing of full mouth will be done | Procedure or surgery | periodontal treatment group |
Primary outcome
serum albumin levels
Time frame: 6 months
serum albumin levels are considered to be strong predictor of death in dialysis patients. in this trial we want to see the effect of non surgical periodontal therapy on serum albumin levels of patients on maintenance dialysis therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
- Background: PubMed 16476040Bots CP, Poorterman JH, Brand HS, Kalsbeek H, van Amerongen BM, Veerman EC, Nieuw Amerongen AV. The oral health status of dentate patients with chronic renal failure undergoing dialysis therapy. Oral Dis. 2006 Mar;12(2):176-80. doi: 10.1111/j.1601-0825.2005.01183.x.
Related trials for End Stage Renal Failure on Dialysis
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication
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.
Ayyaz A Khan, PhD study director
Shaikh Zayed Medical CompleX lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing non-surgical periodontal therapy in people with End Stage Renal Failure on Dialysis and Periodontitis, run by University of the Punjab at 1 site in Pakistan.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 2012. 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 Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
serum albumin levels (time frame: 6 months). 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 NCT01641757, which also lists 1 linked publication.
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 18 Jul 2012.