Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605547
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
The Effect of I-PRF As An Adjunct to Non-Surgical Periodontal Therapy on Clinical Parameters in Smokers With Periodontitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Injectable Platelet-Rich Fibrin As An Adjunct to Non-Surgical Periodontal Therapy on Clinical Parameters in Smokers With Periodontitis A Split-Mouth Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this clinical trial is to evaluate the effect of subgingival injectable platelet-rich fibrin i-PRF application on clinical periodontal parameters as an adjunct to non-surgical periodontal treatment NSPT in smokers with periodontitis
Twenty-five systemically healthy smoker patients with stage IIIII periodontitis were included in the study In this split-mouth trial subgingival i-PRF was applied to the test group in addition to NSPT while saline was applied to the control group after NSPT Subgingival i-PRFsaline application was repeated on the 7th day in both groups Clinical periodontal parameters were recorded at baseline 1st and 3rd months after the treatment
Twenty-five systemically healthy smoker patients with stage IIIII periodontitis were included in the study In this split-mouth trial subgingival i-PRF was applied to the test group in addition to NSPT while saline was applied to the control group after NSPT Subgingival i-PRFsaline application was repeated on the 7th day in both groups Clinical periodontal parameters were recorded at baseline 1st and 3rd months after the treatment
Detailed Description:
Twenty-five systemically healthy smoker patients with periodontitis were included in the study All individuals were examined at baseline 1st and 3rd months after non-surgical periodontal treatment including whole mouth probing pocket depth PPD clinical attachment loss CAL presence of bleeding on probing BOP gingival index GI and Turesky Modified Quigley-Hein Plaque Index TQHPI except the third molars PPD and CAL were measured at six sites per tooth using a manual periodontal probe All measurements and NSPT were performed by the same blinded and calibrated examiner TCG
The NSPT included supra- and subgingival scaling root planing and oral hygiene instructions Subgingival scaling and root planing were performed under local anesthesia within the 24 h After NSPT four contralateral deep pockets two for each side in premolarmolar ares were determined The sites were randomly divided into test sites receiving the subgingival application of i-PRF and controls treated with saline
After the NSPT was completed the i-PRF was produced as follows 9 mL of whole blood was collected from the antecubital vein in a sterile plastic tubes without anticoagulant and immediately centrifuged at 700 rpm for 3 minutes with a centrifuge device After centrifugation the upper liquid layer was collected as i-PRF and placed into an insulin syringe connected to a 29G needle
Before the i-PRF application the teeth were isolated with a cotton roll and dried with a cotton pellet The 29-gauge needle tip was gently placed into the periodontal pocket and the i-PRF was injected into the periodontal pocket until it reached the gingival margin until it overflowed from the sulcus For the subgingival saline application the insulin syringe was filled with saline and the 29-gauge needle tip was gently placed into the periodontal pocket The saline was injected into the periodontal pocket until it was seen to overflow from the gingival margin After the subgingival application of i-PRFsaline the application areas were isolated and waited for 10 minutes in order to prevent the i-PRF from being removed from the sulcus with oral fluids until it turned into a gel Subgingival i-PRFsalin application was performed by a periodontist BMYPatients were instructed not to drink or eat anything including water for at least 30 minutes after the procedure Patients were informed about oral hygiene practices tooth brushing and interdental cleaning and were motivated to perform daily oral care Patients were given an appointment for the second application of i-PRFsalin application 7 days later In this session i-PRFsalin application was applied to the previously applied areas oral hygiene was checked and patients were informed again Patients were called again in the 1st and 3rd months periodontal clinical measurements were repeated and oral hygiene motivation was given
Statistical analyses were performed using a statistical analysis software SPSS v250 IBM The Shapiro Wilk test was used to determine the normality of the present data and the variance homogeneity was checked with the Levene test For non-normally distributed data the Mann Whitney U test was used for pairwise comparison The Independent Samples T test was performed for normally distributed data The Friedman test was used to examine the differences between three dependent groups Bonferroni correction was performed for multiple variations The statistical significance value was accepted as p amplt 005
The NSPT included supra- and subgingival scaling root planing and oral hygiene instructions Subgingival scaling and root planing were performed under local anesthesia within the 24 h After NSPT four contralateral deep pockets two for each side in premolarmolar ares were determined The sites were randomly divided into test sites receiving the subgingival application of i-PRF and controls treated with saline
After the NSPT was completed the i-PRF was produced as follows 9 mL of whole blood was collected from the antecubital vein in a sterile plastic tubes without anticoagulant and immediately centrifuged at 700 rpm for 3 minutes with a centrifuge device After centrifugation the upper liquid layer was collected as i-PRF and placed into an insulin syringe connected to a 29G needle
Before the i-PRF application the teeth were isolated with a cotton roll and dried with a cotton pellet The 29-gauge needle tip was gently placed into the periodontal pocket and the i-PRF was injected into the periodontal pocket until it reached the gingival margin until it overflowed from the sulcus For the subgingival saline application the insulin syringe was filled with saline and the 29-gauge needle tip was gently placed into the periodontal pocket The saline was injected into the periodontal pocket until it was seen to overflow from the gingival margin After the subgingival application of i-PRFsaline the application areas were isolated and waited for 10 minutes in order to prevent the i-PRF from being removed from the sulcus with oral fluids until it turned into a gel Subgingival i-PRFsalin application was performed by a periodontist BMYPatients were instructed not to drink or eat anything including water for at least 30 minutes after the procedure Patients were informed about oral hygiene practices tooth brushing and interdental cleaning and were motivated to perform daily oral care Patients were given an appointment for the second application of i-PRFsalin application 7 days later In this session i-PRFsalin application was applied to the previously applied areas oral hygiene was checked and patients were informed again Patients were called again in the 1st and 3rd months periodontal clinical measurements were repeated and oral hygiene motivation was given
Statistical analyses were performed using a statistical analysis software SPSS v250 IBM The Shapiro Wilk test was used to determine the normality of the present data and the variance homogeneity was checked with the Levene test For non-normally distributed data the Mann Whitney U test was used for pairwise comparison The Independent Samples T test was performed for normally distributed data The Friedman test was used to examine the differences between three dependent groups Bonferroni correction was performed for multiple variations The statistical significance value was accepted as p amplt 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None