Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06118177 |
| Other study ID # |
16.08.2022/12 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 5, 2022 |
| Est. completion date |
August 8, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Pamukkale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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 5/0 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 (G*Power; Universitat, Dusseldorf, Germany) for α =
0.05 and effect size = 0.26. 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 data's 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 < 0.05.
