Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05395455
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2022-05-24
Brief Title:
Gingival Crevicular Fluid Salivary and Serum Biomarkers Levels in Periodontal Treatment
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Effect of Non-surgical Periodontal Treatment on Gingival Crevicular Fluid Salivary and Serum Interleukin-26 Levels in Stage III Grade B and C Periodontitis
Status:
COMPLETED
Status Verified Date:
2022-05
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 gingival crevicular fluid GCF saliva and serum IL-26 IL-6 and IL-10 levels in stage III grade B periodontitis SIII-GB-P and C periodontitis SIII-GC-P patients 25 periodontally healthy 25 SIII-GB-P and 25 SIII-GC-P participants were enrolled At baseline GCF saliva and serum samples were collected and the whole mouth clinical periodontal parameters were recorded Periodontitis patients received non-surgical periodontal treatment NSPT Clinical parameters and samples were re-collected at 1 and 3 months after NSPT GCF saliva and serum IL-26 IL-6 and IL-10 were analyzed by ELISA Data were analyzed using appropriate statistical tests
Detailed Description:
Periodontitis is an inflammatory process that can result in tooth loss by destroying teeth-supporting tissues Interleukin IL 26 is one of the recent members of the IL-10 cytokine family The elevated level of IL-26 expression is associated with inflammatory disorders
IL-6 a pro-inflammatory cytokine and is one of the important molecules in the regulation of inflammatory immune responses in periodontitis IL-10 an anti-inflammatory cytokine affects monocytes and macrophages and their immune mediator release
This study is the first controlled clinical study that examines the levels of IL-26 in GCF saliva and serum in two different periodontitis and evaluates the situation before and after the treatment The first hypothesis of this study GCF salivary and serum IL-26 and IL-6 levels will be high and GCF salivary and serum IL-10 will be low in periodontitis groups in contrast to the periodontal health the second hypothesis of this study is that after periodontal treatment GCF saliva and serum IL-26 and IL-6 will decrease and GCF saliva and serum IL-10 will increase
Based on these hypotheses the aim of the study is to compare the levels of IL-26 IL-6 and IL-10 in GCF saliva and serum of healthy controls SIII-GB-P and SIII-GC-P subjects and to evaluate the effect of periodontal treatment
A total of 75 systemically healthy patients 25 periodontally healthy 25 SIII-GB-P and 25 SIII-GC-P were included in this study The clinical periodontal examination including measurement of probing depth PD clinical attachment level CAL bleeding on probing BOP gingival index GI and plaque index PI was performed at 6 sites per tooth except the third molars The presence of alveolar bone loss was assessed on the digital panoramic radiograph in each participant which was supplemented with periapical radiographs if necessary
The periodontal status of each patient was evaluated by a single calibrated periodontist 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 n25 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 and exhibited no history of periodontitis The periodontitis stage III patients had a minimum of 3 teeth apart from the first molars and incisors showing CAL 5 mm and PD 6 mm and showed no4 teeth loss caused by periodontitis The radiographic bone loss extends 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 n25 If higher than 10 the patients were assigned to grade C n25
Treatment The periodontitis patients received conventional 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 treatment
GCF Saliva and Serum Sampling Filter paper strips were used to collect GCF samples In the healthy control group GCF was collected from the interproximal sites of single-rooted and multiple rooted teeth from each quadrant GCF was collected from the sites with PD 6 mm and radiographic bone loss in periodontitis groups Selected sites were isolated with cotton rolls The paper strip was removed after 30 sec after inserting the periodontal pocket A total of 5 mL of unstimulated whole saliva was collected by the passive drool method in the morning The saliva was collected over a period of 5 minutes with instructions to pool saliva on the floor of the mouth and passively drool it into a sterile glass beaker and samples are immediately transferred to a 2 mL polypropylene tube 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 All the samples were stored at -80C
Biomarker Immunoassays GCF 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 GCF serum and salivary samples of IL-26 IL-10 and IL-6 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 the 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 the Mann-Whitney U test was performed The Spearmans rank correlation test was used to detect the correlations of biochemical parameters with clinical parameters and each other in periodontitis group before and after treatment All tests were performed at a significance level of p005
IL-6 a pro-inflammatory cytokine and is one of the important molecules in the regulation of inflammatory immune responses in periodontitis IL-10 an anti-inflammatory cytokine affects monocytes and macrophages and their immune mediator release
This study is the first controlled clinical study that examines the levels of IL-26 in GCF saliva and serum in two different periodontitis and evaluates the situation before and after the treatment The first hypothesis of this study GCF salivary and serum IL-26 and IL-6 levels will be high and GCF salivary and serum IL-10 will be low in periodontitis groups in contrast to the periodontal health the second hypothesis of this study is that after periodontal treatment GCF saliva and serum IL-26 and IL-6 will decrease and GCF saliva and serum IL-10 will increase
Based on these hypotheses the aim of the study is to compare the levels of IL-26 IL-6 and IL-10 in GCF saliva and serum of healthy controls SIII-GB-P and SIII-GC-P subjects and to evaluate the effect of periodontal treatment
A total of 75 systemically healthy patients 25 periodontally healthy 25 SIII-GB-P and 25 SIII-GC-P were included in this study The clinical periodontal examination including measurement of probing depth PD clinical attachment level CAL bleeding on probing BOP gingival index GI and plaque index PI was performed at 6 sites per tooth except the third molars The presence of alveolar bone loss was assessed on the digital panoramic radiograph in each participant which was supplemented with periapical radiographs if necessary
The periodontal status of each patient was evaluated by a single calibrated periodontist 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 n25 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 and exhibited no history of periodontitis The periodontitis stage III patients had a minimum of 3 teeth apart from the first molars and incisors showing CAL 5 mm and PD 6 mm and showed no4 teeth loss caused by periodontitis The radiographic bone loss extends 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 n25 If higher than 10 the patients were assigned to grade C n25
Treatment The periodontitis patients received conventional 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 treatment
GCF Saliva and Serum Sampling Filter paper strips were used to collect GCF samples In the healthy control group GCF was collected from the interproximal sites of single-rooted and multiple rooted teeth from each quadrant GCF was collected from the sites with PD 6 mm and radiographic bone loss in periodontitis groups Selected sites were isolated with cotton rolls The paper strip was removed after 30 sec after inserting the periodontal pocket A total of 5 mL of unstimulated whole saliva was collected by the passive drool method in the morning The saliva was collected over a period of 5 minutes with instructions to pool saliva on the floor of the mouth and passively drool it into a sterile glass beaker and samples are immediately transferred to a 2 mL polypropylene tube 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 All the samples were stored at -80C
Biomarker Immunoassays GCF 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 GCF serum and salivary samples of IL-26 IL-10 and IL-6 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 the 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 the Mann-Whitney U test was performed The Spearmans rank correlation test was used to detect the correlations of biochemical parameters with clinical parameters and each other in periodontitis group before and after treatment All tests were performed at a significance level of p005
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