PeriodontitisPhase 2NCT02081976
Periodontal Therapy in a Primary Prevention of Cardiovascular Disease
A Phase 2 study testing Integrated Care Group in people with Periodontitis and Coronary Disease, run by Macmillan Research Group UK at 1 site in India.
Trial summary
Cardiovascular diseases (CVD) are still considered the main cause of mortality and morbidity all over the world. In the last years, efforts have been made to define more effective therapeutic and preventive strategies.Periodontal diseases have been considered a probable risk factor for CVD with a great amount of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontitis, Coronary Disease
- What is being tested?
- Integrated Care Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2013to Jan 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals having at least 50% of their dentition with periodontal probing pocket depths N4 mm and
- With documented radiographic alveolar bone loss were included
Who cannot join
- Known systemic diseases
- History and/or presence of other infections
- Systemic antibiotic treatment in the preceding 3 months
- Treatment with any medication known to affect the serum level of inflammatory markers, lipids, or BP
- Pregnant or lactating females
- Allergy to tetracyclines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Trial to Study Effects of Periodontal Therapy in Primary Prevention of Cardiovascular Disease.
Cardiovascular diseases (CVD) are still considered the main cause of mortality and morbidity all over the world. In the last years, efforts have been made to define more effective therapeutic and preventive strategies.Periodontal diseases have been considered a probable risk factor for CVD with a great amount of evidence from observational studies. Although there are some interventional studies evaluating the systemic effects of periodontal therapy, there is little information regarding the impact of periodontal treatment on the prevention of cardiovascular events. To the best of our knowledge, there are no randomized controlled trials published to date assessing the effect of periodontal therapy in primary prevention of CVD.
- Conditions
- Periodontitis, Coronary Disease
- Being tested
- Integrated Care Group, Standard Care Group
- Medical subject headings
- Periodontitis, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Care GroupBehavioural
The group (TG) consisted of periodontal treatment comprising one session of supragingival scaling and personalized oral hygiene instructions, followed by one to four sessions of subgingival scaling and root planing (SRP) by quadrant, under local anesthesia, in a period of 14 days. Individuals were be followed monthly during the first 6 months. In the follow-up sessions, professional plaque removal, oral hygiene instructions, cardiac support along with counseling reinforcement were be provided.
Standard Care GroupOther
The group (TG) comprising one session of supragingival scaling followed by one to four sessions of subgingival scaling and root planing (SRP) by quadrant, under local anesthesia, in a period of 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | Active comparator | Dental therapist providing standard periodontal treatment Receives: Other: Standard Care Group |
| Integrated Care Group | Experimental | a combined treatment approach of Dental Therapist, Dental Hygienist, Cardiologist along with counselor Receives: Behavioral: Integrated Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides)
Measured: Change from baseline to six month
Secondary outcomes (2)
High- and low-density lipoprotein cholesterol
Measured: Change from baseline to six month
cardiovascular risk scores (Framingham)
Measured: Change from baseline to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startApr 2013
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macmillan Research Group UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Saibliss Healthcare Vision
- Responsible party
- Sponsor
- Investigators
- Neelam Maheshwari, BDS, Principal investigator, Maheshwari Dental ClinicNeha Sharma, PhD, Study director, Macmillan Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081976
- Sponsor's protocol ID
- Mac/Saibliss 2120
- Status last verified
- Mar 2014
- First submitted
- 6 Mar 2014
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial to Study Effects of Periodontal Therapy in Primary Prevention of Cardiovascular Disease.
- ClinicalTrials.gov ID
- NCT02081976
- Acronym / sponsor ID
- Mac/Saibliss 2120
- Conditions
- Periodontitis, Coronary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Macmillan Research Group UKIndustry (pharma, biotech, devices)
- Collaborators
- Saibliss Healthcare Vision
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 7 Mar 2014 (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.
Cardiovascular diseases (CVD) are still considered the main cause of mortality and morbidity all over the world. In the last years, efforts have been made to define more effective therapeutic and preventive strategies.Periodontal diseases have been considered a probable risk factor for CVD with a great amount of evidence from observational studies. Although there are some interventional studies evaluating the systemic effects of periodontal therapy, there is little information regarding the impact of periodontal treatment on the prevention of cardiovascular events. To the best of our knowledge, there are no randomized controlled trials published to date assessing the effect of periodontal therapy in primary prevention of CVD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | Active comparator | Other: Standard Care GroupDental therapist providing standard periodontal treatment |
| Integrated Care Group | Experimental | Behavioral: Integrated Care Groupa combined treatment approach of Dental Therapist, Dental Hygienist, Cardiologist along with counselor |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Individuals having at least 50% of their dentition with periodontal probing pocket depths N4 mm and
- With documented radiographic alveolar bone loss were included
Key exclusion criteria (6 listed)
- Known systemic diseases
- History and/or presence of other infections
- Systemic antibiotic treatment in the preceding 3 months
- Treatment with any medication known to affect the serum level of inflammatory markers, lipids, or BP
- Pregnant or lactating females
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 |
|---|---|---|
| Integrated Care GroupThe group (TG) consisted of periodontal treatment comprising one session of supragingival scaling and personalized oral hygiene instructions, followed by one to four sessions of subgingival scaling and root planing (SRP) by quadrant, under local anesthesia, in a period of 14 days. Individuals were be followed monthly during the first 6 months. In the follow-up sessions, professional plaque removal, oral hygiene instructions, cardiac support along with counseling reinforcement were be provided. | Behavioural | Integrated Care Group |
| Standard Care GroupThe group (TG) comprising one session of supragingival scaling followed by one to four sessions of subgingival scaling and root planing (SRP) by quadrant, under local anesthesia, in a period of 14 days. | Other | Standard Care Group |
Primary outcome
Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides)
Time frame: Change from baseline to six month
2 secondary outcomes
High- and low-density lipoprotein cholesterol
Time frame: Change from baseline to six month
cardiovascular risk scores (Framingham)
Time frame: Change from baseline to six 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 7 Mar 2014.
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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.
Neelam Maheshwari, BDS principal investigator
Maheshwari Dental Clinic
Neha Sharma, PhD study director
Macmillan Research Group
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 Integrated Care Group in people with Periodontitis and Coronary Disease, run by Macmillan Research Group UK 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 2 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: finished, as of the sponsor's last update on 7 Mar 2014. 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.
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?
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?
Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides) (time frame: Change from baseline to six 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 7 Mar 2014.