Chronic Periodontitis (CP) Subjects.Phase 4NCT02583841
"Effect of Scaling and Root Planing on Liver Function Test (Alanine Aminotransferase and Aspartate Aminotransferase) in Systemically Healthy - Chronic Periodontitis Subjects: a Clinical Trial."
A Phase 4 study testing Scaling and root planing in people with Chronic Periodontitis (CP) Subjects., run by Tatyasaheb Kore Dental College.
Trial summary
Aim: To evaluate effect of non- surgical periodontal therapy on liver function in systemically healthy chronic periodontitis (CP) subjects. Materials and methods: The study is non surgical interventional trial, includes 50 CP subjects in the age group of 35- 60 years selected from the OPD (Out Patient Department) of… Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis (CP) Subjects.
- 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
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Mar 2015
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with CP (moderate and severe) as per Centers for disease control and prevention (CDC) criteria 2007.
- Patients without any known systemic diseases
- -
Who cannot join
- Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
- Subjects who have undergone periodontal treatment within six months of inception of study.
- Smokers, tobacco habits in any form and alcoholics.
- Pregnant and lactating women.
- -
About this study
Aim:
To evaluate effect of non- surgical periodontal therapy on liver function in systemically healthy chronic periodontitis (CP) subjects.
Read more
Materials and methods:
The study is non surgical interventional trial, includes 50 CP subjects in the age group of 35- 60 years selected from the OPD (Out Patient Department) of department of periodontology Tatyasaheb Kore Dental College and Research center (TKDC and RC), Kolhapur. CP subjects were equally divided into test group and control group. Liver function test- aspartate aminotransferase (AST), alanine aminotransferase (ALT) were checked at baseline and at 1 month after treatment. Clinical examination includes plaque index, gingival index, sulcus bleeding index, probing depth, clinical attachment loss.
- Conditions
- Chronic Periodontitis (CP) Subjects.
- 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
scaling and root planing as an intervention was done in patients of the test group
| Study group | Role | What they receive |
|---|---|---|
| Scaling and Root Planing( SRP) | Active comparator | This was an interventional study in which scaling and root planing was done in systemically healthy patients with chronic periodontitis Receives: Procedure: Scaling and root planing |
| Control Group | No intervention | Scaling and root planing was not done , that is no intervention is carried out in the patients of this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine aminotransferase
Measured: 1month
Aspartate aminotransferase
Measured: 1 month
Secondary outcomes (5)
plaque index
Measured: 1month
gingival index
Measured: 1 month
sulcus bleeding index
Measured: 1month
probing depth
Measured: 1month
Clinical attachment loss
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 posted22 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 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 Periodontitis (CP) Subjects.Studies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatyasaheb Kore Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pradnya Rajendra Khatavkar, Tatyasaheb Kore Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583841
- Sponsor's protocol ID
- TatyasahebKoreDentalC
- Status last verified
- Oct 2015
- First submitted
- 17 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Scaling and Root Planing on Liver Function Test (Alanine Aminotransferase and Aspartate Aminotransferase) in Systemically Healthy - Chronic Periodontitis Subjects: a Clinical Trial."
- ClinicalTrials.gov ID
- NCT02583841
- Acronym / sponsor ID
- TatyasahebKoreDentalC
- Conditions
- Chronic Periodontitis (CP) Subjects.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tatyasaheb Kore Dental CollegeUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Oct 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.
Aim:
To evaluate effect of non- surgical periodontal therapy on liver function in systemically healthy chronic periodontitis (CP) subjects.
Materials and methods:
The study is non surgical interventional trial, includes 50 CP subjects in the age group of 35- 60 years selected from the OPD (Out Patient Department) of department of periodontology Tatyasaheb Kore Dental College and Research center (TKDC and RC), Kolhapur. CP subjects were equally divided into test group and control group. Liver function test- aspartate aminotransferase (AST), alanine aminotransferase (ALT) were checked at baseline and at 1 month after treatment. Clinical examination includes plaque index, gingival index, sulcus bleeding index, probing depth, clinical attachment loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scaling and Root Planing( SRP) | Active comparator | Procedure: Scaling and root planingThis was an interventional study in which scaling and root planing was done in systemically healthy patients with chronic periodontitis |
| Control Group | No intervention | –Scaling and root planing was not done , that is no intervention is carried out in the patients of this group. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects with CP (moderate and severe) as per Centers for disease control and prevention (CDC) criteria 2007.
- Patients without any known systemic diseases
- -
Key exclusion criteria (5 listed)
- Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
- Subjects who have undergone periodontal treatment within six months of inception of study.
- Smokers, tobacco habits in any form and alcoholics.
- Pregnant and lactating women.
- -
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 planingscaling and root planing as an intervention was done in patients of the test group | Procedure or surgery | Scaling and Root Planing( SRP) |
Primary outcome
Alanine aminotransferase
Time frame: 1month
Aspartate aminotransferase
Time frame: 1 month
5 secondary outcomes
plaque index
Time frame: 1month
gingival index
Time frame: 1 month
sulcus bleeding index
Time frame: 1month
probing depth
Time frame: 1month
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 22 Oct 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Scaling and root planing in people with Chronic Periodontitis (CP) Subjects., run by Tatyasaheb Kore Dental College.
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 22 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Alanine aminotransferase (time frame: 1month). The study lists 2 primary outcomes in all. 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 22 Oct 2015.