Chronic PeriodontitisNCT05663476
NSPT On Vitronectin And Fetuin-A Levels In Patients With Periodontitis And Coronary Artery Disease
A study testing Non Surgical Periodontal Therapy in people with Chronic Periodontitis and Cardiovascular Diseases, run by Meenakshi Ammal Dental College and Hospital at 1 site in India.
Trial summary
Periodontitis is a chronic inflammatory disease mainly caused by the oral microbial biofilm. It involves the periodontal supporting tissues mainly features gum inflammation, alveolar bone resorption, periodontal pocket formation, and tooth loosening but also induces various systemic diseases, which seriously affect… Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Cardiovascular Diseases, Periodontal Inflammation
- What is being tested?
- Non Surgical Periodontal Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2023to 1 May 2024
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients willing to participate in the study.
- Patients within the age group of 30-65 years (male)
- Patients should have ≥ 10 remaining natural teeth.
- No history of long term antibiotic use in past 6 months.
Who cannot join
- Subjects with systemic conditions such as type I and type II diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies/neoplasm and HIV infection will be excluded from the present investigation.
- Chronic treatment (>2 weeks) with drugs known to affect periodontal tissues (phenytoin or cyclosporin).
- Female patients were excluded due to hormonal variations.
- For Group II and III, subjects on drugs such as corticosteroids, antibiotics, within 6 months of investigation will be excluded.
- Current smokers and individuals who quit smoking less than 6 months.
- Patients who have undergone periodontal therapy within the previous 6 months.
Trial locations and contacts
1 site in 1 country.
India1 site
Meenakshi Ammal Dental College and Hospital
Chennai, Tamil Nadu, 600095
Dr. JAIDEEP MAHENDRA, M.D.S, Ph.D. Post Doc (USA), 09444963973, jaideep_m_23@yahoo.co.in
Dr. PAVITHRA H DAVE, BDS, 09962705033, pavithradave1997@gmail.com
About this study
Official title: Effect Of Non Surgical Therapy On Vitronectin And Fetuin-A Levels In Patients With Periodontitis And Coronary Artery Disease- An Interventional Study
Periodontitis is a chronic inflammatory disease mainly caused by the oral microbial biofilm. It involves the periodontal supporting tissues mainly features gum inflammation, alveolar bone resorption, periodontal pocket formation, and tooth loosening but also induces various systemic diseases, which seriously affect the physical and mental health of patients. The response to periodontal infection is mediated by various intracellular signalling pathways leading to the production of numerous bio-molecules. Vitronectin is a multifunctional protein with a multiple binding domain that interacts with a variety of plasma and cell proteins. It belongs to the group of adhesive glycoproteins that is involved in various functions including complement activation, blood coagulation, binding to proteoglycans, and modification of the matrix. Among the various cystatins expressed in serum and saliva, Fetuin-A, an another protein is produced majorly by healthy hepatic and adipose tissues. Fetuin-A has been recognized as a multifunctional molecule related to its role in metabolic processes, insulin resistance, regulation of adipogenesis and mineralization throughout the body. The study aims to determine the expression of Vitronectin and Fetuin-A as potential pro-inflammatory and anti-inflammatory biomarkers respectively. These protein molecules can further play a role as putative risk indicators in periodontitis subjects with and without coronary artery disease following non-surgical therapy.
Read the detailed description
Periodontitis is a chronic inflammatory disease mainly caused by the oral microbial biofilm. It involves the periodontal supporting tissues mainly features gum inflammation, alveolar bone resorption, periodontal pocket formation, and tooth loosening but also induces various systemic diseases, which seriously affect the physical and mental health of patients. The response to periodontal infection is mediated by various intracellular signaling pathways leading to the production of numerous bio-molecules. Vitronectin is a multifunctional protein with multiple binding domains that interact with a variety of plasma and cell proteins. It belongs to the group of adhesive glycoproteins that are involved in various functions including complement activation, blood coagulation, binding to proteoglycans, and modification of the matrix. Among the various cystatins expressed in serum and saliva, Fetuin-A, another protein is produced majorly by healthy hepatic and adipose tissues. Fetuin-A has been recognized as a multifunctional molecule related to its role in metabolic processes, insulin resistance, regulation of adipogenesis, and mineralization throughout the body. To find out the effect of non-surgical therapy on the periodontal and cardiac parameters and the salivary levels of Vitronectin and Fetuin-A in patients with periodontitis (stage II-III) and coronary artery disease.
- Being tested
- Non Surgical Periodontal Therapy
- Medical subject headings
- Chronic Periodontitis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Surgical Periodontal TherapyOther
Scaling and root planing using scalers and periodontal curettes will be done
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Periodontally and systemically healthy participants Receives: Other: Non Surgical Periodontal Therapy |
| Periodontitis without coronary artery disease | Experimental | Periodontitis participants without coronary artery disease Receives: Other: Non Surgical Periodontal Therapy |
| Periodontitis with coronary artery disease | Experimental | Periodontitis participants with coronary artery disease Receives: Other: Non Surgical Periodontal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in periodontal parameters
Reduction in PPD (measured in mm)
Measured: Two years
Reduction in periodontal variables
Reduction in CAL (measured in mm)
Measured: Two years
Reduction in periodontal criteria
Reduction in Plaque Index (measured in numericals)
Measured: Two years
Reduction in periodontal variables
Reduction in Gingival index (measured in numericals)
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 May 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three arm clinical trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meenakshi Ammal Dental College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663476
- Sponsor's protocol ID
- MADC/IEC-1/18/2022
- Status last verified
- Apr 2023
- First submitted
- 10 Nov 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Non Surgical Therapy On Vitronectin And Fetuin-A Levels In Patients With Periodontitis And Coronary Artery Disease- An Interventional Study
- ClinicalTrials.gov ID
- NCT05663476
- Acronym / sponsor ID
- MADC/IEC-1/18/2022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meenakshi Ammal Dental College and HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 23 Dec 2022 (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.
Periodontitis is a chronic inflammatory disease mainly caused by the oral microbial biofilm. It involves the periodontal supporting tissues mainly features gum inflammation, alveolar bone resorption, periodontal pocket formation, and tooth loosening but also induces various systemic diseases, which seriously affect the physical and mental health of patients. The response to periodontal infection is mediated by various intracellular signalling pathways leading to the production of numerous bio-molecules. Vitronectin is a multifunctional protein with a multiple binding domain that interacts with a variety of plasma and cell proteins. It belongs to the group of adhesive glycoproteins that is involved in various functions including complement activation, blood coagulation, binding to proteoglycans, and modification of the matrix. Among the various cystatins expressed in serum and saliva, Fetuin-A, an another protein is produced majorly by healthy hepatic and adipose tissues. Fetuin-A has been recognized as a multifunctional molecule related to its role in metabolic processes, insulin resistance, regulation of adipogenesis and mineralization throughout the body. The study aims to determine the expression of Vitronectin and Fetuin-A as potential pro-inflammatory and anti-inflammatory biomarkers respectively. These protein molecules can further play a role as putative risk indicators in periodontitis subjects with and without coronary artery disease following non-surgical therapy.
Detailed description
Periodontitis is a chronic inflammatory disease mainly caused by the oral microbial biofilm. It involves the periodontal supporting tissues mainly features gum inflammation, alveolar bone resorption, periodontal pocket formation, and tooth loosening but also induces various systemic diseases, which seriously affect the physical and mental health of patients. The response to periodontal infection is mediated by various intracellular signaling pathways leading to the production of numerous bio-molecules. Vitronectin is a multifunctional protein with multiple binding domains that interact with a variety of plasma and cell proteins. It belongs to the group of adhesive glycoproteins that are involved in various functions including complement activation, blood coagulation, binding to proteoglycans, and modification of the matrix. Among the various cystatins expressed in serum and saliva, Fetuin-A, another protein is produced majorly by healthy hepatic and adipose tissues. Fetuin-A has been recognized as a multifunctional molecule related to its role in metabolic processes, insulin resistance, regulation of adipogenesis, and mineralization throughout the body. To find out the effect of non-surgical therapy on the periodontal and cardiac parameters and the salivary levels of Vitronectin and Fetuin-A in patients with periodontitis (stage II-III) and coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Other: Non Surgical Periodontal TherapyPeriodontally and systemically healthy participants |
| Periodontitis without coronary artery disease | Experimental | Other: Non Surgical Periodontal TherapyPeriodontitis participants without coronary artery disease |
| Periodontitis with coronary artery disease | Experimental | Other: Non Surgical Periodontal TherapyPeriodontitis participants with coronary artery disease |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients willing to participate in the study.
- Patients within the age group of 30-65 years (male)
- Patients should have ≥ 10 remaining natural teeth.
- No history of long term antibiotic use in past 6 months.
Key exclusion criteria (6 listed)
- Subjects with systemic conditions such as type I and type II diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies/neoplasm and HIV infection will be excluded from the present investigation.
- Chronic treatment (>2 weeks) with drugs known to affect periodontal tissues (phenytoin or cyclosporin).
- Female patients were excluded due to hormonal variations.
- For Group II and III, subjects on drugs such as corticosteroids, antibiotics, within 6 months of investigation will be excluded.
- Current smokers and individuals who quit smoking less than 6 months.
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 TherapyScaling and root planing using scalers and periodontal curettes will be done | Other | Control group, Periodontitis with coronary artery disease, Periodontitis without coronary artery disease |
Primary outcome
Reduction in periodontal parameters
Time frame: Two years
Reduction in PPD (measured in mm)
Reduction in periodontal variables
Time frame: Two years
Reduction in CAL (measured in mm)
Reduction in periodontal criteria
Time frame: Two years
Reduction in Plaque Index (measured in numericals)
Reduction in periodontal variables
Time frame: Two years
Reduction in Gingival index (measured in numericals)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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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.
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 Chronic Periodontitis and Cardiovascular Diseases, run by Meenakshi Ammal Dental College and 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 4 inclusion and 6 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 13 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in periodontal parameters (time frame: Two years). The study lists 4 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 13 Apr 2023.