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CompletedNCT02081976Updated Mar 7, 2014

Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

A Phase 2 interventional study of Integrated Care Group and Standard Care Group in Periodontitis and Coronary Disease, sponsored by Macmillan Research Group UK. Completed at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-03-07.

Sponsored by Macmillan Research Group UK · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 57 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Macmillan Research Group UK is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Individuals having at least 50% of their dentition with periodontal probing pocket depths N4 mm and
  • With documented radiographic alveolar bone loss were included

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
57 participants (actual)

Study arms

  • Active comparator
    Standard Care Group

    Dental therapist providing standard periodontal treatment

    Other: Standard Care Group

  • Experimental
    Integrated Care Group

    a combined treatment approach of Dental Therapist, Dental Hygienist, Cardiologist along with counselor

    Behavioral: Integrated Care Group

Interventions

  • BehavioralIntegrated Care Group

    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.

  • OtherStandard Care Group

    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.

06

What researchers measure

Primary outcomes

  1. Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides)

    Time frame: Change from baseline to six month

Secondary outcomes

  1. High- and low-density lipoprotein cholesterol

    Time frame: Change from baseline to six month

  2. cardiovascular risk scores (Framingham)

    Time frame: Change from baseline to six months

Other outcomes

  1. Blood Pressure and Sugar

    Time frame: Change from baseline to six months

07

Study locations

1 site
  • GyanSanjeevani
    Jaipur, Rajasthan 302019, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02081976
Lead sponsor
Macmillan Research Group UK
Collaborators
Saibliss Healthcare Vision
Responsible party
Sponsor
First posted
Mar 7, 2014
Start date
Apr 2013
Primary completion
Oct 2013
Completion
Jan 2014
Last update
Mar 7, 2014

Study contacts

Neelam Maheshwari, BDS
principal investigator · Maheshwari Dental Clinic
Neha Sharma, PhD
study director · Macmillan Research Group

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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