Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05741970
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2022-11-16
Brief Title:
Interaction Between Hypertension and Periodontitis
Sponsor:
Gazi University
Organization:
Gazi University
Study Overview
Official Title:
Interaction Between Hypertension and Periodontitis
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ObjectiveThe 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 MethodsForty 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 ResultsBefore the periodontal treatment significantly higher GCF IL-6 and CRP levels were detected in CPHP and CP groups compared to HP and control groups p001 Salivary CRP level in CPHP group was found to be higher than the control group p005 Statistically significant gingival and plaque index measurements p001 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 Conclusionthe 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 localsystemic antibiotics and antimicrobial agentsPatients 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 BOP10 and PD3 mmThe 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 29120811 and all patients signed an informed consent form Exclusion criteria were smoking pregnancy established secondary hypertension diagnosis other systemic diseases and previous periodontal andor antibiotic treatment within the last six months All patients with periodontitis received phase I periodontal therapy including oral hygiene instruction OHI and scalingroot 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 01 bovine serum albuminphosphate buffered saline solution in Eppendorf tubes and the fluid from the paper strip was eluted by centrifugation for 6 minutes at 5000 g at 4 C Following centrifugation the strips were removedThe 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 15000 g at 4C to remove any particulate matter The supernatants were stored at -20C 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 manufacturers instructions Results were expressed as pgmL Total amounts were also calculated by multiplying concentrations and CRP volumes
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 localsystemic antibiotics and antimicrobial agentsPatients 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 BOP10 and PD3 mmThe 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 29120811 and all patients signed an informed consent form Exclusion criteria were smoking pregnancy established secondary hypertension diagnosis other systemic diseases and previous periodontal andor antibiotic treatment within the last six months All patients with periodontitis received phase I periodontal therapy including oral hygiene instruction OHI and scalingroot 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 01 bovine serum albuminphosphate buffered saline solution in Eppendorf tubes and the fluid from the paper strip was eluted by centrifugation for 6 minutes at 5000 g at 4 C Following centrifugation the strips were removedThe 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 15000 g at 4C to remove any particulate matter The supernatants were stored at -20C 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 manufacturers instructions Results were expressed as pgmL Total amounts were also calculated by multiplying concentrations and CRP volumes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None