Chronic PeriodontitisNCT02636114
Effect of Scaling and Root Planing on Serum Renal Function Markers in Chronic Periodontitis Subjects.
A study testing scaling and root planing in people with Chronic Periodontitis, run by Maharashtra University of Health Sciences at 1 site in India.
Trial summary
ABSTRACT:- Introduction: Chronic periodontitis (CP), the commonest type of periodontal disease, it is an infectious disease resulting in inflammation within of the tissues supporting the teeth, progressive loss of attachment and bone loss. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2015to Mar 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group 35-60 years.
- Subjects should have at least 20 natural teeth.
- Subjects who have not received periodontal therapy, within preceding six months.
- Patients with chronic generalized periodontitis (moderate and severe) according to CDC working group, 2007 criteria.
Who cannot join
- Tobacco in any form and alcoholics.
- Any other systemic disease which can alter the course of periodontal disease.
- Subjects should have pregnant, women on hormone replacement therapy or hormonal contraceptives, patients taking steroidal or non-steroidal anti-inflammatory drugs (previous 3 months) or antibiotics (previous 6 months), anti-inflammatory drugs and antibiotics in the previous six month.
- Aggressive periodontitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Scaling and Root Planing on Serum Renal Function Markers in Systematically Healthy Chronic Periodontitis Subjects - A Control Clinical Trial.
ABSTRACT:-
Introduction:
Read more
Chronic periodontitis (CP), the commonest type of periodontal disease, it is an infectious disease resulting in inflammation within of the tissues supporting the teeth, progressive loss of attachment and bone loss. It is closely related to several systemic diseases, such as diabetes and cardiovascular disease. The link between periodontal disease and chronic kidney disease (CKD) may be due to infection and inflammation. The periodontal inflammatory state may increases the chronic inflammation present in CKD, thus decreasing renal function. Periodontal therapy may reduce inflammation and improves endothelial function.
Aim:- To investigate the effect of mechanical non-surgical periodontal therapy on serum renal function markers in systematically healthy CP subjects.
Objectives:- To evaluate the effect of scaling and root planing (SRP) on serum renal function markers such as urea, creatinine, bilurubin in systematically healthy CP patient and to compare the clinical parameters such as Gingival index (GI), Plaque index (PI), Probing depth (PD), Bleeding on probing (BOP), Clinical attachment level (CAL) between test group (TG) \& control group (CG).
Materials and Methods: - 51 CP patients; age ranging between 35-60 years was selected. Categorized equally into group I and groups II. Group I was test group (TG) included 25 patients and group II was control group (CG) included 26 patients. The serum levels of renal function markers included Urea, Creatinine, Bilurubin were measured. SRP was done in test group only. All the parameters were checked at baseline and one month after SRP. Comparisons of baseline and value after 1 month among each criterion among each group unpaired-t test and comparisons of two groups for each criterion by paired-t test.
Read the detailed description
MATERIAL AND METHODS:- A non-surgical interventional clinical study was carried out from January 2015 to March 2015 in 51 patients at the department of Periodontology, Tatyasaheb Kore Dental College \& Research Centre, New Pargaon. Prior approval for the study was obtained from the local ethical committee.
Patients with chronic generalized periodontitis [(moderate and severe) according to CDC working group, 2007 criteria]. Age ranging from 35-60 ( mean 45) years, should have at least 20 natural teeth, who have not received periodontal therapy, within preceding six months were included in this study. Tobacco in any form and alcoholics, any other systemic disease which can alter the course of periodontal disease, subjects should have pregnant, women on hormone replacement therapy or hormonal contraceptives, patients taking steroidal or non-steroidal anti-inflammatory drugs (previous 3 months) or antibiotics (previous 6 months), anti-inflammatory drugs and antibiotics in the previous six month and patients with aggressive periodontitis were excluded from this study.
Study was explained, including the benefits, risks and alternative treatments, the patients signed an informed consent form indicating their agreement to participate in the study and each patient was assigned a patient number in ascending order to maintain the masking of evaluators. Eg. First patient is given a number D1, Second D2, and so on.
GROUPS This was a Phase 2 clinical trial with an Interventional model of parallel assignment with two arms. Hence, after screening through inclusion and exclusion criteria patients were divided into two groups, 25 (13 males and 12 females) patients were included in TG and 26 (13 males and 13 females) subjects included in CG.
INTERVENTION:- The study was non-surgical controlled clinical trial. A single study co-ordinator patients into two groups by using Quick Cals, Graph pad software and it has stratified with a 1:1 allocation. SRP had performed for all subjects in TG at baseline by one trained Periodontist under local anaesthesia (if required) using Piezoelectric scaler [Satelec ACTEON P5TM], Hand scalers, Universal curette and Gracey Curette. Clinical and biochemical parameters had recorded by trained examiner in both TG and CG.
BLOOD COLLECTION:- 5 ml of blood was collected from the antecubital fossa by venipuncture using 20-guage needle with 5 ml syringes. Blood samples were left to clot for (1-2) hours, then centrifuged to obtain the serum. Serum was collected in disposable plastic serum containing tube, which was stored at (2-40C) until time of assay. Estimation of levels of urea (by GLDH- urease method), bilirubin total (by Diazo Method), creatinine (modified JAFFE'S method) was done at the baseline and one month in both the groups, at ANANT laboratory, kodoli, Kolhapur (INDIA).
- Conditions
- Chronic Periodontitis
- Being tested
- scaling and root planing
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling and root planingProcedure or surgery
Also called Non surgical periodontal therapy
Scaling and root planing at baseline , checked clinical parameter and serum renal function markers at baseline and 1 month after therapy
| Study group | Role | What they receive |
|---|---|---|
| scaling and root planing | Active comparator | this was an international study in which scaling and root planing was done in systemically healthy patients patients with chronic periodontitis Receives: Procedure: scaling and root planing |
| control group | No intervention | Scaling and planing was not done that no intervention is carried out in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine, serum urea, serum bilirubin
to evaluate serum renal markers at baseline and 1 month after scaling and root planing
Measured: 1 month
Secondary outcomes (4)
plaque index
to evaluate plaque index at baseline and 1 month after scaling and root planing
Measured: 1 month
gingival index
to evaluate gingival index at baseline and 1 month after scaling and root planing
Measured: 1 month
pocket depth
to evaluate pocket depth at baseline and 1 month after scaling and root planing
Measured: 1 month
clinical attachment loss
to evaluate clinical attachment loss at baseline and 1 month after scaling and root planing
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharashtra University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sagar Kadam, Maharashtra University of Health Sciences
- Investigators
- sagar kadam, MDS, Principal investigator, muhs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636114
- Sponsor's protocol ID
- MaharashtraUHS
- Status last verified
- Dec 2015
- First submitted
- 3 Dec 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: renal function markers report
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Scaling and Root Planing on Serum Renal Function Markers in Systematically Healthy Chronic Periodontitis Subjects - A Control Clinical Trial.
- ClinicalTrials.gov ID
- NCT02636114
- Acronym / sponsor ID
- MaharashtraUHS
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Maharashtra University of Health SciencesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 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.
ABSTRACT:-
Introduction:
Chronic periodontitis (CP), the commonest type of periodontal disease, it is an infectious disease resulting in inflammation within of the tissues supporting the teeth, progressive loss of attachment and bone loss. It is closely related to several systemic diseases, such as diabetes and cardiovascular disease. The link between periodontal disease and chronic kidney disease (CKD) may be due to infection and inflammation. The periodontal inflammatory state may increases the chronic inflammation present in CKD, thus decreasing renal function. Periodontal therapy may reduce inflammation and improves endothelial function.
Aim:- To investigate the effect of mechanical non-surgical periodontal therapy on serum renal function markers in systematically healthy CP subjects.
Objectives:- To evaluate the effect of scaling and root planing (SRP) on serum renal function markers such as urea, creatinine, bilurubin in systematically healthy CP patient and to compare the clinical parameters such as Gingival index (GI), Plaque index (PI), Probing depth (PD), Bleeding on probing (BOP), Clinical attachment level (CAL) between test group (TG) \& control group (CG).
Materials and Methods: - 51 CP patients; age ranging between 35-60 years was selected. Categorized equally into group I and groups II. Group I was test group (TG) included 25 patients and group II was control group (CG) included 26 patients. The serum levels of renal function markers included Urea, Creatinine, Bilurubin were measured. SRP was done in test group only. All the parameters were checked at baseline and one month after SRP. Comparisons of baseline and value after 1 month among each criterion among each group unpaired-t test and comparisons of two groups for each criterion by paired-t test.
Detailed description
MATERIAL AND METHODS:- A non-surgical interventional clinical study was carried out from January 2015 to March 2015 in 51 patients at the department of Periodontology, Tatyasaheb Kore Dental College \& Research Centre, New Pargaon. Prior approval for the study was obtained from the local ethical committee.
Patients with chronic generalized periodontitis [(moderate and severe) according to CDC working group, 2007 criteria]. Age ranging from 35-60 ( mean 45) years, should have at least 20 natural teeth, who have not received periodontal therapy, within preceding six months were included in this study. Tobacco in any form and alcoholics, any other systemic disease which can alter the course of periodontal disease, subjects should have pregnant, women on hormone replacement therapy or hormonal contraceptives, patients taking steroidal or non-steroidal anti-inflammatory drugs (previous 3 months) or antibiotics (previous 6 months), anti-inflammatory drugs and antibiotics in the previous six month and patients with aggressive periodontitis were excluded from this study.
Study was explained, including the benefits, risks and alternative treatments, the patients signed an informed consent form indicating their agreement to participate in the study and each patient was assigned a patient number in ascending order to maintain the masking of evaluators. Eg. First patient is given a number D1, Second D2, and so on.
GROUPS This was a Phase 2 clinical trial with an Interventional model of parallel assignment with two arms. Hence, after screening through inclusion and exclusion criteria patients were divided into two groups, 25 (13 males and 12 females) patients were included in TG and 26 (13 males and 13 females) subjects included in CG.
INTERVENTION:- The study was non-surgical controlled clinical trial. A single study co-ordinator patients into two groups by using Quick Cals, Graph pad software and it has stratified with a 1:1 allocation. SRP had performed for all subjects in TG at baseline by one trained Periodontist under local anaesthesia (if required) using Piezoelectric scaler [Satelec ACTEON P5TM], Hand scalers, Universal curette and Gracey Curette. Clinical and biochemical parameters had recorded by trained examiner in both TG and CG.
BLOOD COLLECTION:- 5 ml of blood was collected from the antecubital fossa by venipuncture using 20-guage needle with 5 ml syringes. Blood samples were left to clot for (1-2) hours, then centrifuged to obtain the serum. Serum was collected in disposable plastic serum containing tube, which was stored at (2-40C) until time of assay. Estimation of levels of urea (by GLDH- urease method), bilirubin total (by Diazo Method), creatinine (modified JAFFE'S method) was done at the baseline and one month in both the groups, at ANANT laboratory, kodoli, Kolhapur (INDIA).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scaling and root planing | Active comparator | Procedure: scaling and root planingthis was an international study in which scaling and root planing was done in systemically healthy patients patients with chronic periodontitis |
| control group | No intervention | –Scaling and planing was not done that no intervention is carried out in this group |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age group 35-60 years.
- Subjects should have at least 20 natural teeth.
- Subjects who have not received periodontal therapy, within preceding six months.
- Patients with chronic generalized periodontitis (moderate and severe) according to CDC working group, 2007 criteria.
Key exclusion criteria (4 listed)
- Tobacco in any form and alcoholics.
- Any other systemic disease which can alter the course of periodontal disease.
- Subjects should have pregnant, women on hormone replacement therapy or hormonal contraceptives, patients taking steroidal or non-steroidal anti-inflammatory drugs (previous 3 months) or antibiotics (previous 6 months), anti-inflammatory drugs and antibiotics in the previous six month.
- Aggressive periodontitis.
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 planingAlso: Non surgical periodontal therapyScaling and root planing at baseline , checked clinical parameter and serum renal function markers at baseline and 1 month after therapy | Procedure or surgery | scaling and root planing |
Primary outcome
serum creatinine, serum urea, serum bilirubin
Time frame: 1 month
to evaluate serum renal markers at baseline and 1 month after scaling and root planing
4 secondary outcomes
plaque index
Time frame: 1 month
gingival index
Time frame: 1 month
pocket depth
Time frame: 1 month
clinical attachment loss
Time frame: 1 month
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 21 Dec 2015.
- Individual participant dataSharing planned: Yes. renal function markers report
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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.
sagar kadam, MDS principal investigator
muhs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scaling and root planing in people with Chronic Periodontitis, run by Maharashtra University of Health Sciences at 1 site in India.
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 4 inclusion and 4 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 21 Dec 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 India. 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?
serum creatinine, serum urea, serum bilirubin (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2015.