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Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

A Randomized, Controlled Trial to Study Effects of Periodontal Therapy in Primary Prevention of Cardiovascular Disease.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02081976
Enrollment
57
Registered
2014-03-07
Start date
2013-04-30
Completion date
2014-01-31
Last updated
2014-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis, Coronary Disease

Brief 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.

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.

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.

Sponsors

Saibliss Healthcare Vision
CollaboratorUNKNOWN
Macmillan Research Group UK
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

* 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

Design outcomes

Primary

MeasureTime frame
Traditional cardiovascular risk markers (total cholesterol, LDL-C, HDL-C and triglycerides)Change from baseline to six month

Secondary

MeasureTime frame
High- and low-density lipoprotein cholesterolChange from baseline to six month
cardiovascular risk scores (Framingham)Change from baseline to six months

Other

MeasureTime frame
Blood Pressure and SugarChange from baseline to six months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026