Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06118177
Status:
COMPLETED
Last Update Posted:
2023-11-08
First Post:
2023-10-31
Brief Title:
Ultrasonographic Assessment of Palatal Wound Healing
Sponsor:
Pamukkale University
Organization:
Pamukkale University
Study Overview
Official Title:
Ultrasonographic Assessment of the Effects of Platelet Rich Fibrin on Wound Healing Following Palatal Connective Tissue Harvesting
Status:
COMPLETED
Status Verified Date:
2023-11
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:
Palatal-tissue harvesting is a routinely performed procedure in periodontal plastic surgery Subepithelial connective tissue graft sCTG is considered the gold standard in root coverage However over the years several materials have been attempted to accelerate wound healing and to decrease the post-operative patient discomfort and pain which are considered the most common disadvantages of tissue harvesting from the palate Reharvesting from the same region could be necessary in some complicated gingical recessions For this reason patients may face long treatment times due to recovery periods of the palate between surgeries
Platelet-rich fibrin PRF which has 3-dimensional fibrin matrix structure contributes to regeneration of surgical wounds by releasing growth factors for 10-14 days and showing angiogenic properties
In medicine and dentistry ultrasonography USG method can be used to measure tissue thickness vascularization elasticity and blood flow USG as a non-invasive method can provide objective data in evaluating the effects of surgical techniques and biomaterials used on soft tissue healing dynamics and tissue perfusion
The investigators hypothesised that leukocyte rich PRF L-PRF application to the palatal area after sCTG harvesting could increase palatal tissue thickness and vascularity throughout 3-month follow-up period compared to the controls Therefore in this study the investigators aimed to evaluate the effects of the L-PRF membrane on soft tissue donor site healing after harvesting sCTG in terms of wound healing dynamics using USG method
Platelet-rich fibrin PRF which has 3-dimensional fibrin matrix structure contributes to regeneration of surgical wounds by releasing growth factors for 10-14 days and showing angiogenic properties
In medicine and dentistry ultrasonography USG method can be used to measure tissue thickness vascularization elasticity and blood flow USG as a non-invasive method can provide objective data in evaluating the effects of surgical techniques and biomaterials used on soft tissue healing dynamics and tissue perfusion
The investigators hypothesised that leukocyte rich PRF L-PRF application to the palatal area after sCTG harvesting could increase palatal tissue thickness and vascularity throughout 3-month follow-up period compared to the controls Therefore in this study the investigators aimed to evaluate the effects of the L-PRF membrane on soft tissue donor site healing after harvesting sCTG in terms of wound healing dynamics using USG method
Detailed Description:
This study was planned as a randomized prospective controlled study Patients with Miller class 1 or 2 gingival recession who needs root coverage surgery in the Department of Periodontology were included in the study The subepithelial connective tissue graft was obtained in each patient using the single incision technique from the region between the mesial of canine and the mesial of first molar in the palate Connective tissue dimensions were approximately 10 5 2 mm Finally the incision line was sutured with 50 synthetic nonabsorbable sterile monofilament suture in the control group while L-PRF membrane was placed to the donor site in the test group before the suturing Patients were evaluated using an ultrasonography device MyLab Seven Esaote Genoa Italy at the Department of Oral and Maxillofacial Radiology USG measurements were performed on days 0 3 7 14 21 30 and 90 for palatal tissue thickness and tissue vascularization by an oral and maxillofacial radiologist with at least six years of experience A 6-18 MHz intraoral probe was used in intraoral USG examinations Sterile gel was applied to the intraoral probe and covered with a stretch film Then it was placed directly on the mucosal surface of the donor site in the palatal area Mucosal thickness was evaluated using the B-mode of the device and vascularization was evaluated using the color doppler and pulsed wave doppler modes of the device The mean pulsatility index PI values of each patient were calculated and considered for statistical analysis
The power analyse of the study was performed for sample size calculation Sample size was calculated using a statistical program GPower Universitat Dusseldorf Germany for α 005 and effect size 026 The analyses revealed that 10 subjects per group achieved a power of 80 with 95 confidence
The data were analysed with the SPSS 21 program SPSS Inc Chicago IL Continuous variables were presented as mean standard deviation and categorical variables as numbers and percentages Shapiro-Wilk test was used to detect datas normality For the comparison of the parameters of the study groups independent samples T-test test was used for normally distributed data while Mann Whitney U test test was performed as non-parametric test Within-group comparisons between the different time periods were tested with repeated measures of ANOVA Bonferroni correction was performed for multiple variations The statistical significance value was accepted as p 005
The power analyse of the study was performed for sample size calculation Sample size was calculated using a statistical program GPower Universitat Dusseldorf Germany for α 005 and effect size 026 The analyses revealed that 10 subjects per group achieved a power of 80 with 95 confidence
The data were analysed with the SPSS 21 program SPSS Inc Chicago IL Continuous variables were presented as mean standard deviation and categorical variables as numbers and percentages Shapiro-Wilk test was used to detect datas normality For the comparison of the parameters of the study groups independent samples T-test test was used for normally distributed data while Mann Whitney U test test was performed as non-parametric test Within-group comparisons between the different time periods were tested with repeated measures of ANOVA Bonferroni correction was performed for multiple variations The statistical significance value was accepted as 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