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Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

M

Macmillan Research Group UK

Status and phase

Completed
Phase 2

Conditions

Periodontitis
Coronary Disease

Treatments

Behavioral: Integrated Care Group
Other: Standard Care Group

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT02081976
Mac/Saibliss 2120

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

57 participants in 2 patient groups

Standard Care Group
Active Comparator group
Description:
Dental therapist providing standard periodontal treatment
Treatment:
Other: Standard Care Group
Integrated Care Group
Experimental group
Description:
a combined treatment approach of Dental Therapist, Dental Hygienist, Cardiologist along with counselor
Treatment:
Behavioral: Integrated Care Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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