Impact of Periodontal Intervention on Vascular Dysfunction

NCT ID: NCT01917292

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-06-30

Brief Summary

The purpose of this study is to determine the effect of periodontal intervention on vascular dysfunction among Chinese prehypertensive adults with moderate to severe periodontal disease.

Detailed Description

Periodontitis is one of the low-grade chronic diseases, and it is the principal cause of tooth loss among middle-aged and elderly. Recently, epidemiological data indicate that patients with periodontitis are associated with increases in blood pressure levels and hypertension prevalence. Furthermore, studies from cross-sectional investigations demonstrate that hypertensive patients with periodontitis may enhance the risk and degree of vascular damage. Therefore, periodontal therapy is a novel therapeutic strategy to prevent the occurrence of BP elevation and retard the development vascular injury.

The term "prehypertension" indicates those with BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic blood pressure. Accumulating evidence suggests that subjects with prehypertension is associated with higher incidence of atherosclerotic vascular disease. However, until now there are no available data to investigate the influence of periodontitis on prehypertension and whether periodontal intervention may reduce the BP rise in subjects with prehypertension and improve the vascular function. We hypothesized that periodontitis leads to elevation in BP and periodontal therapy improves vascular function in subjects with prehypertension. To address these assumptions, The present study is designed to study the effect of periodontal intervention on blood pressure and vascular function and inflammatory biomarkers among Chinese prehypertensive adults with moderate to severe periodontal disease, and determine whether intensive periodontal therapy improves these measures over a 6-month follow-up period.

Conditions

Chronic Periodontitis; Prehypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Periodontal care

Group Type: OTHER

Periodontal care

Intervention Type: PROCEDURE

1. Basic oral hygiene instructions

2. Standard cycle of supragingival ultrasonic scaling and polishing

One-Stage Full-Mouth Disinfection

Group Type: EXPERIMENTAL

One-Stage Full-Mouth Disinfection

Intervention Type: PROCEDURE

1. Basic oral hygiene instructions

2. Dental extractions will be performed (only in cases of teeth that could not be saved)

3. Standard cycle of supragingival ultrasonic scaling and polishing

4. Scaling and root planning after the administration of local anesthesia, four quadrants in one session

5. Minocycline Hydrochloride Ointment (Periocline, OraPharma) were delivered locally into the periodontal pockets

Interventions

One-Stage Full-Mouth Disinfection

1. Basic oral hygiene instructions

2. Dental extractions will be performed (only in cases of teeth that could not be saved)

3. Standard cycle of supragingival ultrasonic scaling and polishing

4. Scaling and root planning after the administration of local anesthesia, four quadrants in one session

5. Minocycline Hydrochloride Ointment (Periocline, OraPharma) were delivered locally into the periodontal pockets

Intervention Type: PROCEDURE

Periodontal care

1. Basic oral hygiene instructions

2. Standard cycle of supragingival ultrasonic scaling and polishing

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Subjects must be 18 years of age or older

2. Moderate to severe generalized periodontitis(probing pocket depths of >6 mm and Marginal alveolar bone loss of >30%) with 50% or more of their teeth affected

3. Have at least 16 natural teeth excluding third molars

4. BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic blood pressure

5. Provide informed consent and willingness to cooperate with the study protocol

Exclusion Criteria

1. History of antibiotic use in the previous three months

2. Pregnant or lactating females

3. Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases

4. Medical history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease, cerebrovascular accident, hypertension

5. Patients who received periodontal treatment within the last 6 months

6. Patients who require antibiotic prophylaxis before examination or treatment

7. Patients with mental retardation and dementia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Junying Yang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Ying Yang, Master

Role: STUDY_DIRECTOR

First Affiliated Hospital, Sun Yat-Sen University

Jun Tao, M.D.,phD.

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

References

Zhou QB, Xia WH, Ren J, Yu BB, Tong XZ, Chen YB, Chen S, Feng L, Dai J, Tao J, Yang JY. Effect of Intensive Periodontal Therapy on Blood Pressure and Endothelial Microparticles in Patients With Prehypertension and Periodontitis: A Randomized Controlled Trial. J Periodontol. 2017 Aug;88(8):711-722. doi: 10.1902/jop.2017.160447. Epub 2017 Apr 28.

Reference Type: DERIVED

PMID: 28452620 (View on PubMed)

Other Identifiers

31270992

Identifier Type: REGISTRY

Identifier Source: secondary_id

20130718emp

Identifier Type: -

Identifier Source: org_study_id