Effects of Non-surgical Periodontal Therapy on Cardiovascular Risk

NCT05459727 | Not Yet Recruiting

• 1 other identifier: NFEC-2022-243
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 2

Brief Summary

This study is to evaluate whether non-surgical periodontal therapy can help to control the cardiovascular risk among patients with moderate/severe periodontitis and at risk of cardiovascular disease.

Conditions

Cardiovascular Diseases; Periodontitis

Keywords

Periodontitis; Non-surgical Periodontal Therapy; Cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Cardiovascular risk (Framingham risk score (FRS)) at 1 year.

  Cardiovascular risk is assessed by "Framingham risk score (FRS)". (Circulation, 2008,117(6): 743-753.) Generally, the "Framingham risk score (FRS)" ranges from -4 to 33 for men and -5 to 33 for women. A higher "Framingham risk score (FRS)" means a higher risk of developing cardiovascular disease.

  Baseline; 1 year

Secondary Outcomes (16)

• Change from baseline systolic blood pressure at 1 year after enrollment.

  Baseline; 1 year

• Change from baseline diastolic blood pressure at 1 year after enrollment.

  Baseline; 1 year

• Change from baseline fasting blood glucose at 1 year after enrollment.

  Baseline; 1 year

• Change from baseline glycosylated hemoglobin at 1 year after enrollment.

  Baseline; 1 year

• Change from baseline total cholesterol at 1 year after enrollment.

  Baseline; 1 year

Study Arms (2)

Intervention arm

EXPERIMENTAL

1. Basic oral hygiene instructions. 2. Full-mouth subgingival scaling and root planing under local anesthesia. 3. Additional full-mouth subgingival scaling and root planing under local anesthesia every 3 months during the follow-up period if necessary.

Procedure: Non-surgical periodontal therapy

Control arm

PLACEBO COMPARATOR

1. Basic oral hygiene instructions. 2. Full-mouth supragingival ultrasonic scaling.

Procedure: Control periodontal treatment

Interventions

Non-surgical periodontal therapy PROCEDURE

Non-surgical periodontal therapy includes basic oral hygiene instructions and full-mouth subgingival scaling and root planing under local anesthesia.

Intervention arm

Control periodontal treatment PROCEDURE

Control periodontal treatment includes basic oral hygiene instructions and full-mouth supragingival ultrasonic scaling.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• At risk of cardiovascular disease (defined as "Framingham Score" predicted 10-year risk of cardiovascular disease ≥ 20%);
• Moderate//severe periodontitis;

You may not qualify if:

• Cardiovascular diseases at baseline (coronary heart disease, stroke and peripheral artery disease);
• Received periodontal treatment within the past 6 months;
• Pregnant or lactating females;
• Non residents of Guangzhou and its surrounding cities or expected to leave Guangzhou or its surrounding cities within 1 year;
• Malignant tumors or other end-stage diseases with life expectancy less than 1 year;
• End-stage renal disease;
• Patients with high bleeding risk, high blood pressures or other situations that make them unable to receive interventions;
• Refuse to provide informed consent;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Southern Medical University, China: collaborator

Study Sites (2)

Stomatological Hospital, Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jiancheng Xiu, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiancheng Xiu, MD

CONTACT

+86-020-61648319; xiujch@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the characteristics of the intervention in this trial, it would be impossible to blind the enrolled participants. However, the investigators and outcomes assessors will be blinded. Allocation to arms will be concealed in an envelope and revealed to the stomatologist and patient before delivering the first treatment. Other investigators like outcomes assessors and staff involved in the data collection and analyses will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 15, 2022
• Study Start: August 1, 2022
• Primary Completion: August 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 15, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)