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Interaction Between Hypertension and Periodontitis

Primary Purpose

Hypertension, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scaling and root planing
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension focused on measuring IL-6, CRP, Periodontitis, Hypertension, Phase I therapy

Eligibility Criteria

39 Years - 58 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Hypertensive patients with at least 5 years of followup were included in the hypertension group. Exclusion Criteria: Hypertension patients treated with antihypertensive drugs known to cause gingival overgrowth were excluded from the study. Other exclusion criteria were diabetes mellitus, high cholesterol levels, CVD and drugs usage other than antihypertensive drugs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    No Intervention

    Active Comparator

    No Intervention

    Arm Label

    IL-6 and CRP levels of the hypertensive and periodontitis group

    IL-6 and CRP levels of the hypertensive and healthy group

    IL-6 and CRP levels of the periodontitis and healthy group

    IL-6 and CRP levels of the systemically and periodontally healthy group

    Arm Description

    All patients with periodontitis received phase I periodontal therapy including oral hygiene instruction (OHI) and scaling/root planning (SRP) without any antimicrobial therapy. GCF and saliva samples were obtained and clinical measurements were performed at baseline (before treatment (BT) and four weeks (4 weeks 3 days) after the phase I periodontal therapy (AT).

    GCF and saliva samples were obtained and clinical measurements were performed at baseline

    All patients with periodontitis received phase I periodontal therapy including oral hygiene instruction (OHI) and scaling/root planning (SRP) without any antimicrobial therapy. GCF and saliva samples were obtained and clinical measurements were performed at baseline (before treatment (BT) and four weeks (4 weeks 3 days) after the phase I periodontal therapy (AT).

    GCF and saliva samples were obtained and clinical measurements were performed at baseline

    Outcomes

    Primary Outcome Measures

    Salivary and Gingival crevicular fluid Interleukin-6 and CRP
    pg/mL unite
    Plaque index and Gingival index
    scores from 1-3
    Pocket depth and Clinical attachment level
    mm
    Bleeding on probing
    percentage

    Secondary Outcome Measures

    Gingival crevicular fluid volume
    microgram

    Full Information

    First Posted
    November 16, 2022
    Last Updated
    February 14, 2023
    Sponsor
    Gazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05741970
    Brief Title
    Interaction Between Hypertension and Periodontitis
    Official Title
    Interaction Between Hypertension and Periodontitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2, 2017 (Actual)
    Primary Completion Date
    March 30, 2018 (Actual)
    Study Completion Date
    June 25, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gazi University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objective:The possible association between hypertension and periodontitis and the effect of hypertension on periodontal treatment were investigated by evaluating salivary and gingival crevicular fluid (GCF) interleukin (IL)-6 and C reactive protein (CRP) levels. Methods:Forty two healthy individuals without any previously diagnosed systemic disease [10 periodontally healthy (control) and 10 periodontitis (CP)] and subjects with hypertension [13 periodontally healthy (HP) and 9 with periodontitis (CP + HP)] participated in the study. GCF and saliva samples were obtained at baseline and four weeks after Phase I periodontal treatment. Biochemical parameters were analyzed using ELISA. Results:Before the periodontal treatment, significantly higher GCF IL-6 and CRP levels were detected in CP+HP and CP groups compared to HP and control groups (p<0.01). Salivary CRP level in CP+HP group was found to be higher than the control group (p<0.05). Statistically significant gingival and plaque index measurements (p<0.01) might suggest a possible effect of hypertension on periodontal status. Periodontal treatment significantly improved the clinical indices, however biochemical parameters did not change after the treatment. Conclusion:the association of hypertension with periodontitis through local salivary and GCF mediators might be possible in disease process.
    Detailed Description
    Forty-two participants were included in the study. The study groups consisted of 20 healthy individuals without any previously diagnosed systemic disease (10 periodontally healthy and 10 with periodontitis) and 22 patients with hypertension (13 periodontally healthy and 9 with periodontitis). The patient population was randomly selected among the patients who referred to Periodontology Clinic. Hypertensive patients with at least 5 years of follow up were included in the hypertension group. Hypertension patients treated with antihypertensive drugs known to cause gingival overgrowth were excluded from the study. Other exclusion criteria were diabetes mellitus, high cholesterol levels, CVD and drugs usage other than antihypertensive drugs. A calibrated examiner performed a comprehensive periodontal examination included plaque index (Silness & Loe, 1964) (PI), gingival index (Loe & Silness, 1963) (GI), probing depth (PD), clinical attachment level (CAL) and bleeding on probing (BOP). The measurements were made at six sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual) using a periodontal probe (Williams periodontal probe, Nordent Manufacturing, Elk Grove Village, IL., USA) To perform the intra-examiner calibration, PD and CAL were measured twice at six sites of each tooth within 24 hours. Intra-examiner agreement was at least 90% for both PD and CAL within 1 mm. Examiner who recorded the clinical indexes was blinded to the systemical status of the patients and the periodontologists who were responsible for patients periodontal treatment were not blinded because of the anesthesia applied to hypertension patients and the precautions needed to be taken. During the study period, patients were instructed not to use any local/systemic antibiotics and antimicrobial agents.Patients diagnosed with periodontitis had Stage II periodontitis in a generalized pattern with probing depths of 3-4mm. The diagnosis was performed based on criteria that maximum probing depth ≤5 mm, mostly horizontal loss and >30% of teeth involved. Healthy periodontium was identified as the presence of BOP≤10% and PD≤3 mm.The deepest four pockets of non-adjacent single rooted teeth were selected for GCF sampling. The participants were distributed into four groups; healthy subjects with healthy periodontal condition (control), healthy subjects with periodontitis (CP), hypertension patients with periodontitis (CP + HP) and hypertension patients with healthy periodontal condition (HP). The study was approved by the local ethics committee (291208/11) and all patients signed an informed consent form. Exclusion criteria were smoking, pregnancy, established secondary hypertension diagnosis, other systemic diseases and previous periodontal and/or antibiotic treatment within the last six months. All patients with periodontitis received phase I periodontal therapy including oral hygiene instruction (OHI) and scaling/root planning (SRP) without any antimicrobial therapy. GCF and saliva samples were obtained and clinical measurements were performed at baseline (before treatment (BT) and four weeks after the phase I periodontal therapy (AT). The timeline for the phase I therapy (within 2 weeks of baseline examination 4 days). Primary biochemical outcome measures included salivary and GCF IL-6 and CRP, and primary periodontal outcome measures were PI, GI, PD, CAL and BOP. Secondary outcome measure was GCF volume. GCF and saliva sampling and processing The GCF sampling site was gently air dried and supragingival plaque was removed. The area was carefully isolated with cotton rolls in order to prevent contamination. Standardized paper strips (Periopaper, Pro Flow, Amityville, NY, USA) were inserted into the sulcus until slight resistance was felt and left in place for 30 seconds. Strips contaminated by bleeding or exudates were discarded. GCF volumes were determined as described previously. To determine the amount of GCF, an electronic balance was used to weigh the paper strips before and immediately after collection. The mass (mg) of the fluid on each strip was converted to a volume in millimeters by assuming that the density of GCF was 1. Strips were placed into coded micro centrifuge tubes and stored at -800C until processing. Before biochemical analysis, paper strips were placed in 0,1 % bovine serum albumin/phosphate buffered saline solution in Eppendorf tubes, and the fluid from the paper strip was eluted by centrifugation for 6 minutes at 5,000 · g at 4 C. Following centrifugation, the strips were removed.The participants were asked to stop eating and drinking 2 hours before each sampling. They were instructed to rinse their mouth for 30 seconds with 10 mL of water and to rest for 2 minutes before unstimulated saliva was collected by spitting. Approximately 1 mL of unstimulated whole saliva was collected into Eppendorf tubes. Samples were centrifuged for 10 minutes at 15.000 × g at 4°C to remove any particulate matter. The supernatants were stored at -20°C until analysed. GCF and saliva enzyme-linked immunosorbent assay (ELISA) analysis for IL-6 and CRPThe levels of IL-6 and CRP in GCF and saliva were measured using a sandwich ELISA kit (Biosource, Invitrogen Corporation, Carlsbad, California 92008). The ELISA procedures were carried out according to the manufacturer's instructions. Results were expressed as pg/mL. Total amounts were also calculated by multiplying concentrations and CRP volumes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Periodontitis
    Keywords
    IL-6, CRP, Periodontitis, Hypertension, Phase I therapy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Examiner who recorded the clinical indexes was blinded to the systemical status of the patients and the periodontologists who were responsible for patients periodontal treatment were not blinded because of the anesthesia applied to hypertension patients and the precautions needed to be taken.
    Allocation
    Non-Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IL-6 and CRP levels of the hypertensive and periodontitis group
    Arm Type
    Active Comparator
    Arm Description
    All patients with periodontitis received phase I periodontal therapy including oral hygiene instruction (OHI) and scaling/root planning (SRP) without any antimicrobial therapy. GCF and saliva samples were obtained and clinical measurements were performed at baseline (before treatment (BT) and four weeks (4 weeks 3 days) after the phase I periodontal therapy (AT).
    Arm Title
    IL-6 and CRP levels of the hypertensive and healthy group
    Arm Type
    No Intervention
    Arm Description
    GCF and saliva samples were obtained and clinical measurements were performed at baseline
    Arm Title
    IL-6 and CRP levels of the periodontitis and healthy group
    Arm Type
    Active Comparator
    Arm Description
    All patients with periodontitis received phase I periodontal therapy including oral hygiene instruction (OHI) and scaling/root planning (SRP) without any antimicrobial therapy. GCF and saliva samples were obtained and clinical measurements were performed at baseline (before treatment (BT) and four weeks (4 weeks 3 days) after the phase I periodontal therapy (AT).
    Arm Title
    IL-6 and CRP levels of the systemically and periodontally healthy group
    Arm Type
    No Intervention
    Arm Description
    GCF and saliva samples were obtained and clinical measurements were performed at baseline
    Intervention Type
    Procedure
    Intervention Name(s)
    Scaling and root planing
    Intervention Description
    Each tooth with inflammation symptoms was cleaned with scalers, curettes and ultrasonic devices routinely.
    Primary Outcome Measure Information:
    Title
    Salivary and Gingival crevicular fluid Interleukin-6 and CRP
    Description
    pg/mL unite
    Time Frame
    change from baseline to postoperative 4 weeks
    Title
    Plaque index and Gingival index
    Description
    scores from 1-3
    Time Frame
    change from baseline to postoperative 4 weeks
    Title
    Pocket depth and Clinical attachment level
    Description
    mm
    Time Frame
    change from baseline to postoperative 4 weeks
    Title
    Bleeding on probing
    Description
    percentage
    Time Frame
    change from baseline to postoperative 4 weeks
    Secondary Outcome Measure Information:
    Title
    Gingival crevicular fluid volume
    Description
    microgram
    Time Frame
    change from baseline to postoperative 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    39 Years
    Maximum Age & Unit of Time
    58 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Hypertensive patients with at least 5 years of followup were included in the hypertension group. Exclusion Criteria: Hypertension patients treated with antihypertensive drugs known to cause gingival overgrowth were excluded from the study. Other exclusion criteria were diabetes mellitus, high cholesterol levels, CVD and drugs usage other than antihypertensive drugs.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33506429
    Citation
    Bengtsson VW, Persson GR, Berglund JS, Renvert S. Periodontitis related to cardiovascular events and mortality: a long-time longitudinal study. Clin Oral Investig. 2021 Jun;25(6):4085-4095. doi: 10.1007/s00784-020-03739-x. Epub 2021 Jan 28.
    Results Reference
    result
    PubMed Identifier
    24585887
    Citation
    Chapple IL, Busby M, Clover H, Matthews R. Periodontal disease and systemic disease. J R Soc Med. 2014 Mar;107(3):94. doi: 10.1177/0141076813518770. No abstract available.
    Results Reference
    result

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    Interaction Between Hypertension and Periodontitis

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