Ignite Creation Date:
2024-05-06 @ 4:30 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05005923
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2021-07-29
Brief Title:
Effect of Periodontal Therapy on Biomarkers in Periodontitis
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Effect of Non-Surgical Periodontal Therapy on Salivary and Serum Biomarkers in Stage III Grade B and C Periodontitis
Status:
COMPLETED
Status Verified Date:
2021-08
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:
The present study aimed to assess the effect of non-surgical periodontal treatment on serum and salivary MMP-8 MAF MIP-1α M-CSF and IL34 levels in periodontitis stage III grade B P-III-B and C P-III-C patients 20 periodontally healthy 20 P-III-B and 25 P-III-C participants were enrolled At baseline serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded Periodontitis patients received non-surgical periodontal treatment Clinical parameters were re-measured and samples were re-collected at 1 and 3 months after treatment Serum and salivary MMP-8 MAF MIP-1α M-CSF and IL34 levels were analyzed by ELISA Data were analyzed using appropriate statistical tests
Detailed Description:
Periodontal disease is an inflammatory process that can result in tooth loss and also is considered a modifying factor for systemic health Matrix metalloproteinase MMP-8 is the major collagenase of periodontal tissue breakdown Macrophage-activating factor MAF can activate macrophages M-CSF is known to modulate disease and inflammation and to play an important role in bone destruction IL-34 shares vital functions of M-CSF and manages myeloid cell survival differentiation and proliferation
This study is the first controlled clinical study that examines the levels of MIP-1α MAF MMP-8 M-CSF IL-34 in saliva and serum in two different periodontitis and evaluates the situation before and after the treatment The first hypothesis of this study in periodontitis group salivary and serum MIP-1α MAF MMP-8 M-CSF IL-34 levels will be high in contrast to the periodontal healthy group The second hypothesis of this study is that after periodontal treatment saliva and serum MIP-1α MAF MMP-8 M-CSF IL-34 levels will decrease Based on these hypotheses the aim of the study is to compare the levels of MIP-1a MAF MMP-8 M-CSF IL-34 in saliva and serum of healthy controls P-III-B and P-III-C subjects and to evaluate the effect of periodontal treatment
A total of 65 systemically healthy patients 20 periodontally healthy 20 P-III-B 25 P-III-C were included in this study The whole mouth clinical periodontal examination included measurement of probing depth PPD clinical attachment level CAL presence of bleeding on probing BOP gingival index GI and plaque index PI at 6 sites per tooth except the third molars The presence and type of the alveolar bone loss were assessed on the digital panoramic radiograph in each participant which was supplemented with periapical radiographs if necessary
Periodontal status of each patient was evaluated by a single calibrated periodontists with a manual probe The diagnosis of periodontitis or periodontally health was determined according to the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions Periodontally healthy individuals n20 in the control group had no sites with PD 3 mm and CAL 2 mm and also no radiographic evidence of alveolar bone loss BOP was 10 in the whole mouth Healthy group also exhibited no history of periodontitis The periodontitis stage III patients had a minimum three teeth apart from the first molars and incisors showing CAL 5 mm and PD 6 mm and showed no4 teeth loss because of periodontitis Radiographic bone loss extending from coronal to middle third or beyond Radiographic bone loss was determined from the tooth showing the most severe bone loss as a percentage of root length If the values of bone loss age were between 025 and 10 the patients were assigned to grade B n20 If higher than 10 the patients were assigned to grade C n25
Treatment
The recruited periodontitis patients received conventional quadrant scaling and root planning SRP under local anesthesia in a total of 4 sessions in two weeks SRP was performed by the same periodontist using ultrasonic inserts and manual periodontal curettes Re-evaluations were performed at 1 and 3 months following the completion of the SRP No periodontal intervention was carried out in the periodontally healthy controls
Saliva and Serum Sampling A total of 5 mL of unstimulated whole saliva was collected by passive drool method between 900 and 1000 am The participants were advised to avoid food consumption for three hours before sample collection The participants were seated upright and saliva was collected over a period of 5 minutes with instructions to pool saliva in the floor of the mouth and passively drool it into a sterile glass beaker Then saliva samples are immediately transferred to a 2 mL polypropylene tube and stored at -80C A total of 5 mL of blood was collected from the antecubital fossa by venepuncture method Serum was isolated from the blood by centrifuging at 5000 rpm for 10 minutes followed by its rapid transfer to a sterile polypropylene tube and storage at -80C
Biomarker Immunoassays Saliva and serum samples were thawed on ice The saliva samples were centrifuged at 5000 rpm for 15 minutes at room temperature and supernatants were immediately used for assays Serum and salivary samples of MMP-8 M-CSF MIP-1α MAF IL-34 in were measured by ELISA using commercial kits
Statistical Analysis All statistical analyses were carried out with the standard statistical software package For the intra-group comparisons if the data were not normally disturbed Friedman test and the Dunn test with the Bonferroni correction were used to analyze the change between baseline and 1 month and 3 months after treatment For inter-group comparisons Mann-Whitney U test for normally and non-normally disturbed data The Spearmans rank correlation test was used to detect the correlations of biochemical parameters with clinical parameters and each others in diseased group before and after treatment All tests were performed at significance level of P 005
This study is the first controlled clinical study that examines the levels of MIP-1α MAF MMP-8 M-CSF IL-34 in saliva and serum in two different periodontitis and evaluates the situation before and after the treatment The first hypothesis of this study in periodontitis group salivary and serum MIP-1α MAF MMP-8 M-CSF IL-34 levels will be high in contrast to the periodontal healthy group The second hypothesis of this study is that after periodontal treatment saliva and serum MIP-1α MAF MMP-8 M-CSF IL-34 levels will decrease Based on these hypotheses the aim of the study is to compare the levels of MIP-1a MAF MMP-8 M-CSF IL-34 in saliva and serum of healthy controls P-III-B and P-III-C subjects and to evaluate the effect of periodontal treatment
A total of 65 systemically healthy patients 20 periodontally healthy 20 P-III-B 25 P-III-C were included in this study The whole mouth clinical periodontal examination included measurement of probing depth PPD clinical attachment level CAL presence of bleeding on probing BOP gingival index GI and plaque index PI at 6 sites per tooth except the third molars The presence and type of the alveolar bone loss were assessed on the digital panoramic radiograph in each participant which was supplemented with periapical radiographs if necessary
Periodontal status of each patient was evaluated by a single calibrated periodontists with a manual probe The diagnosis of periodontitis or periodontally health was determined according to the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions Periodontally healthy individuals n20 in the control group had no sites with PD 3 mm and CAL 2 mm and also no radiographic evidence of alveolar bone loss BOP was 10 in the whole mouth Healthy group also exhibited no history of periodontitis The periodontitis stage III patients had a minimum three teeth apart from the first molars and incisors showing CAL 5 mm and PD 6 mm and showed no4 teeth loss because of periodontitis Radiographic bone loss extending from coronal to middle third or beyond Radiographic bone loss was determined from the tooth showing the most severe bone loss as a percentage of root length If the values of bone loss age were between 025 and 10 the patients were assigned to grade B n20 If higher than 10 the patients were assigned to grade C n25
Treatment
The recruited periodontitis patients received conventional quadrant scaling and root planning SRP under local anesthesia in a total of 4 sessions in two weeks SRP was performed by the same periodontist using ultrasonic inserts and manual periodontal curettes Re-evaluations were performed at 1 and 3 months following the completion of the SRP No periodontal intervention was carried out in the periodontally healthy controls
Saliva and Serum Sampling A total of 5 mL of unstimulated whole saliva was collected by passive drool method between 900 and 1000 am The participants were advised to avoid food consumption for three hours before sample collection The participants were seated upright and saliva was collected over a period of 5 minutes with instructions to pool saliva in the floor of the mouth and passively drool it into a sterile glass beaker Then saliva samples are immediately transferred to a 2 mL polypropylene tube and stored at -80C A total of 5 mL of blood was collected from the antecubital fossa by venepuncture method Serum was isolated from the blood by centrifuging at 5000 rpm for 10 minutes followed by its rapid transfer to a sterile polypropylene tube and storage at -80C
Biomarker Immunoassays Saliva and serum samples were thawed on ice The saliva samples were centrifuged at 5000 rpm for 15 minutes at room temperature and supernatants were immediately used for assays Serum and salivary samples of MMP-8 M-CSF MIP-1α MAF IL-34 in were measured by ELISA using commercial kits
Statistical Analysis All statistical analyses were carried out with the standard statistical software package For the intra-group comparisons if the data were not normally disturbed Friedman test and the Dunn test with the Bonferroni correction were used to analyze the change between baseline and 1 month and 3 months after treatment For inter-group comparisons Mann-Whitney U test for normally and non-normally disturbed data The Spearmans rank correlation test was used to detect the correlations of biochemical parameters with clinical parameters and each others in diseased group before and after treatment All tests were performed at significance level of P 005
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