Interaction Between Hypertension and Periodontitis
1 other identifier
interventional
42
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Jan 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2018
CompletedFirst Submitted
Initial submission to the registry
November 16, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2023
CompletedFebruary 23, 2023
February 1, 2023
1.2 years
November 16, 2022
February 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Salivary and Gingival crevicular fluid Interleukin-6 and CRP
pg/mL unite
change from baseline to postoperative 4 weeks
Plaque index and Gingival index
scores from 1-3
change from baseline to postoperative 4 weeks
Pocket depth and Clinical attachment level
mm
change from baseline to postoperative 4 weeks
Bleeding on probing
percentage
change from baseline to postoperative 4 weeks
Secondary Outcomes (1)
Gingival crevicular fluid volume
change from baseline to postoperative 4 weeks
Study Arms (4)
IL-6 and CRP levels of the hypertensive and periodontitis group
ACTIVE COMPARATORAll 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).
IL-6 and CRP levels of the hypertensive and healthy group
NO INTERVENTIONGCF and saliva samples were obtained and clinical measurements were performed at baseline
IL-6 and CRP levels of the periodontitis and healthy group
ACTIVE COMPARATORAll 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).
IL-6 and CRP levels of the systemically and periodontally healthy group
NO INTERVENTIONGCF and saliva samples were obtained and clinical measurements were performed at baseline
Interventions
Each tooth with inflammation symptoms was cleaned with scalers, curettes and ultrasonic devices routinely.
Eligibility Criteria
You may qualify if:
- Hypertensive patients with at least 5 years of followup were included in the hypertension group.
You may not qualify if:
- Hypertension patients treated with antihypertensive drugs known to cause gingival overgrowth were excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Related Publications (2)
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.
PMID: 33506429RESULTChapple 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.
PMID: 24585887RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 16, 2022
First Posted
February 23, 2023
Study Start
January 2, 2017
Primary Completion
March 30, 2018
Study Completion
June 25, 2018
Last Updated
February 23, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share