Gingivitis and Periodontal DiseasesNCT04198610
Evaluation and Correlation of Serum Fetuin-A Levels in Periodontal Health and Disease: A Clinico-biochemical Study
A study testing Non surgical periodontal therapy in people with Gingivitis and Periodontal Diseases, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The present clinico-biochemical study was carried out to estimate the levels of Fetuin A and MMP7 in serum of systemically healthy subjects in periodontal health and disease and to evaluate the impact of periodontal interventional therapy (scaling and root planing) on the same. Read more about this study
- Who is it for?
- Ages 30 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis and Periodontal Diseases
- 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
- 1 siteIndia
- Study dates
- 10 Mar 2017to 28 Aug 2017
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age group of 30-39 years.
- Systemically healthy subjects.
- Patient who are co-operative and able to attend follow up.
- Patient who have not received any periodontal treatment within the past six months of baseline examination.
- Dentition with at least 20 functional teeth.
Who cannot join
- Medically compromised patients (history of diabetes mellitus, liver diseases, cardiovascular disease, kidney diseases, rheumatoid arthritis, bone diseases pulmonary disease, viral and fungal infections).
- Patients with calcification disorders (chronic kidney disease with vascular calcification, hyperparathyroidism, excessive intake of vitamin D, valvular calcific aortic stenosis
- Aggressive periodontitis.
- Bleeding disorders
- Gross oral pathology and suppuration
- Patients who had received antibiotic therapy and anti inflammatory within the last six months.
- Anomalies of the immune system.
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157
About this study
The present clinico-biochemical study was carried out to estimate the levels of Fetuin A and MMP7 in serum of systemically healthy subjects in periodontal health and disease and to evaluate the impact of periodontal interventional therapy (scaling and root planing) on the same.
Read the detailed description
Sixty sex-matched subjects (30 males and 30 females) belonging to a common age group (30-39 yrs) were enrolled for the study to eliminate bias from confounding factors. They were divided into three groups consisting of 20 subjects in each group based on the clinical and radiological parameters; Periodontally healthy (Group I), Chronic gingivitis (Group II) and chronic periodontitis ( Group IIIa) from whom serum samples were collected. The Group IIIb further comprised of the subjects from Group IIIa, who had received non-surgical periodontal therapy (scaling and root planing). Serum samples were collected at baseline and at 12 weeks post therapy. Fetuin A and MMP-7 concentration was determined from serum samples of patients using ELISA. The results of our study depicted that Fetuin A concentration negatively correlates, whereas, MMP7 positively correlates with the extent of periodontal inflammation. Further, Periodontal therapy demonstrated a significant increase in serum Fetuin A and decrease in MMP 7 levels establishing the influence of periodontal therapy in stabilizing their levels.
- Conditions
- Gingivitis and Periodontal Diseases
- Being tested
- Non surgical periodontal therapy
- Medical subject headings
- Gingivitis, 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
Procedure/Surgery: non surgical periodontal therapy and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 months. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.
| Study group | Role | What they receive |
|---|---|---|
| healthy | No intervention | Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present. |
| chronic gingivitis | No intervention | Chronic gingivitis was defined as having probing depth (PD) less than or equal to 4mm, relative attachment loss (RAL) ) less than or equal to 3mm and more than to 25% sites with gingival bleeding present (BOP) |
| chronic periodontitis | Active comparator | Chronic periodontitis was defined as having probing depth more than or equal to 5mm, RAL more than or equal to 8mm, with more than or equal to 10% sites with BOP positive and evidence of bone loss determined radiographically.
Non surgical periodontal therapy (SRP) was concluded in 3 months. Within the duration of the study, all subjects received supportive therapy Receives: Procedure: Non surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate the change in levels of Fetuin A and MMP7 in serum at baseline and 3 months post SRP
Serum was collected at baseline and 3 months and subjected to ELISA
Measured: Serum collection at baseline and 3 months
Secondary outcomes (5)
Modified Gingival index (GI)
The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group
Measured: At baseline and 3 months
Relative Attachment level (RAL)
The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group
Measured: At baseline and 3 months
Probing Depth (PD)
The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group
Measured: At baseline and 3 months
Bleeding on Probing (BOP%)
The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group
Measured: At baseline and 3 months
Plaque index (PI)
The index was recorded at only baseline for healthy and gingivitis groups and at baseline and 3 months post therapy for periodontitis group
Measured: At baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start10 Mar 2017
- Primary completion28 Aug 2017
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingivitis and Periodontal DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BV Karthikeyan, MDS, Study director, Krishnadevaraya college of Dental sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198610
- Sponsor's protocol ID
- 02_D012_63396
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Correlation of Serum Fetuin-A Levels in Periodontal Health and Disease: A Clinico-biochemical Study
- ClinicalTrials.gov ID
- NCT04198610
- Acronym / sponsor ID
- 02_D012_63396
- Conditions
- Gingivitis and Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 13 Dec 2019 (actual)
- 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 present clinico-biochemical study was carried out to estimate the levels of Fetuin A and MMP7 in serum of systemically healthy subjects in periodontal health and disease and to evaluate the impact of periodontal interventional therapy (scaling and root planing) on the same.
Detailed description
Sixty sex-matched subjects (30 males and 30 females) belonging to a common age group (30-39 yrs) were enrolled for the study to eliminate bias from confounding factors. They were divided into three groups consisting of 20 subjects in each group based on the clinical and radiological parameters; Periodontally healthy (Group I), Chronic gingivitis (Group II) and chronic periodontitis ( Group IIIa) from whom serum samples were collected. The Group IIIb further comprised of the subjects from Group IIIa, who had received non-surgical periodontal therapy (scaling and root planing). Serum samples were collected at baseline and at 12 weeks post therapy. Fetuin A and MMP-7 concentration was determined from serum samples of patients using ELISA. The results of our study depicted that Fetuin A concentration negatively correlates, whereas, MMP7 positively correlates with the extent of periodontal inflammation. Further, Periodontal therapy demonstrated a significant increase in serum Fetuin A and decrease in MMP 7 levels establishing the influence of periodontal therapy in stabilizing their levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy | No intervention | –Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present. |
| chronic gingivitis | No intervention | –Chronic gingivitis was defined as having probing depth (PD) less than or equal to 4mm, relative attachment loss (RAL) ) less than or equal to 3mm and more than to 25% sites with gingival bleeding present (BOP) |
| chronic periodontitis | Active comparator | Procedure: Non surgical periodontal therapyChronic periodontitis was defined as having probing depth more than or equal to 5mm, RAL more than or equal to 8mm, with more than or equal to 10% sites with BOP positive and evidence of bone loss determined radiographically. Non surgical periodontal therapy (SRP) was concluded in 3 months. Within the duration of the study, all subjects received supportive therapy |
Who may qualify
- Ages
- 30 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age group of 30-39 years.
- Systemically healthy subjects.
- Patient who are co-operative and able to attend follow up.
- Patient who have not received any periodontal treatment within the past six months of baseline examination.
- Dentition with at least 20 functional teeth.
Key exclusion criteria (8 listed)
- Medically compromised patients (history of diabetes mellitus, liver diseases, cardiovascular disease, kidney diseases, rheumatoid arthritis, bone diseases pulmonary disease, viral and fungal infections).
- Patients with calcification disorders (chronic kidney disease with vascular calcification, hyperparathyroidism, excessive intake of vitamin D, valvular calcific aortic stenosis
- Aggressive periodontitis.
- Bleeding disorders
- Gross oral pathology and suppuration
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 therapyProcedure/Surgery: non surgical periodontal therapy and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 months. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene. | Procedure or surgery | chronic periodontitis |
Primary outcome
estimate the change in levels of Fetuin A and MMP7 in serum at baseline and 3 months post SRP
Time frame: Serum collection at baseline and 3 months
Serum was collected at baseline and 3 months and subjected to ELISA
5 secondary outcomes
Modified Gingival index (GI)
Time frame: At baseline and 3 months
Relative Attachment level (RAL)
Time frame: At baseline and 3 months
Probing Depth (PD)
Time frame: At baseline and 3 months
Bleeding on Probing (BOP%)
Time frame: At baseline and 3 months
Plaque index (PI)
Time frame: At baseline and 3 months
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 13 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Gingivitis and Periodontal Diseases
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Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
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Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
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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.
BV Karthikeyan, MDS study director
Krishnadevaraya college of Dental sciences
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 Gingivitis and Periodontal Diseases, run by Krishnadevaraya College of Dental Sciences & Hospital 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 5 inclusion and 8 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 13 Dec 2019. 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?
estimate the change in levels of Fetuin A and MMP7 in serum at baseline and 3 months post SRP (time frame: Serum collection at baseline and 3 months). 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 13 Dec 2019.