Impact of Periodontal Intervention on Vascular Dysfunction

NCT01917292 | Completed Phase 3 DMC

• 2 other identifiers: 20130718emp31270992
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis; Prehypertension

Keywords

Periodontitis; Prehypertension; Periodontal Intervention

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in the Number of Endothelial Microparticle at 6 months

  Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

• Change from Baseline in the Blood Pressure at 6 months

  Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

Secondary Outcomes (6)

• Change in Brachia-ankle Pulse Wave Velocity(baPWV)

  Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

• Changes in high-sensitivity C-Reactive Protein(hs-CRP) and Interleukin-6(IL-6)

  Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

• Expression of the Long non-protein-coding RNA(lncRNA) and microRNA

  baseline

• Changes in Malondialdehyde(MDA) and Superoxide Dismutase(SOD)

  Baseline; 1 month post periodontal therapy; 3 months post periodontal therapy; 6 months post periodontal therapy

• Change in Periodontal Inflamed Surface Area(PISA)

  Baseline; 3 months post periodontal therapy; 6 months post periodontal therapy

Study Arms (2)

Periodontal care

OTHER

Procedure: Periodontal care

One-Stage Full-Mouth Disinfection

EXPERIMENTAL

Procedure: One-Stage Full-Mouth Disinfection

Interventions

One-Stage Full-Mouth Disinfection 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

One-Stage Full-Mouth Disinfection

Periodontal care PROCEDURE

1. Basic oral hygiene instructions 2. Standard cycle of supragingival ultrasonic scaling and polishing

Periodontal care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be 18 years of age or older
• 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
• Have at least 16 natural teeth excluding third molars
• BPs ranging from 120 to 139 mm Hg systolic and/or 80 to 89 mm Hg diastolic blood pressure
• Provide informed consent and willingness to cooperate with the study protocol

You may not qualify if:

• History of antibiotic use in the previous three months
• Pregnant or lactating females
• Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
• Medical history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease, cerebrovascular accident, hypertension
• Patients who received periodontal treatment within the last 6 months
• Patients who require antibiotic prophylaxis before examination or treatment
• Patients with mental retardation and dementia

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• 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.

  PMID: 28452620 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Prehypertension; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jun Ying Yang, Master

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

• Jun Tao, M.D.,phD.

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 6, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

CN (1)