Periodontal Therapy in a Primary Prevention of Cardiovascular Disease

NCT02081976 | Completed Phase 2 DMC

• 1 other identifier: Mac/Saibliss 2120
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Coronary Disease

Outcome Measures

Primary Outcomes (1)

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

  Change from baseline to six month

Secondary Outcomes (2)

• High- and low-density lipoprotein cholesterol

  Change from baseline to six month

• cardiovascular risk scores (Framingham)

  Change from baseline to six months

Other Outcomes (1)

• Blood Pressure and Sugar

  Change from baseline to six months

Study Arms (2)

Standard Care Group

ACTIVE COMPARATOR

Dental therapist providing standard periodontal treatment

Other: Standard Care Group

Integrated Care Group

EXPERIMENTAL

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

Behavioral: Integrated Care Group

Interventions

Integrated Care Group BEHAVIORAL

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.

Integrated Care Group

Standard Care Group OTHER

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.

Standard Care Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Macmillan Research Group UK: lead
• Saibliss Healthcare Vision: collaborator

Study Sites (1)

GyanSanjeevani

Jaipur, Rajasthan, 302019, India

Location

MeSH Terms

Conditions

Periodontitis; Coronary Disease

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Neelam Maheshwari, BDS

  Maheshwari Dental Clinic

  PRINCIPAL INVESTIGATOR

• Neha Sharma, PhD

  Macmillan Research Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 7, 2014
• Study Start: April 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

IN (1)