Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06373783 |
| Other study ID # |
2023/05 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2023 |
| Est. completion date |
March 16, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Pamukkale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Gingival recession is a clinical problem that increases with age and affects patient comfort.
It is defined as the displacement of the gingival margin to a more apical position of the
cementum-enamel border of the tooth.
Coronally advanced flap (CAF) or tunnel technique (TUN) with subepithelial connective tissue
procedures have been reported to be the most predictable methods of single gingival recession
treatments. The ultimate goal of these plastic periodontal surgical procedures is to close
the exposed root surface and achieve optimum aesthetic results. The main indications for root
coverage (RC) procedures are aesthetic concern, root hypersensitivity, prevention of cervical
abrasion and root caries, improvement of restorative results, and facilitation of plaque
control. The use of a subepithelial connective tissue graft (SCGT) combined with a coronally
positioned flap is considered the gold standard by many authors for single gingival recession
treatments.
De-epithelialization of free gingival grafts (DGG) has been proposed, especially when palatal
tissue thickness is insufficient (≤2.5 mm) and larger graft size in the apico-coronal or
mesio-distal directions is required. In this technique, the graft of the required width and
length is separated from the lateral side of the palate, and then the 0.3-0.5 mm thick
epithelial layer of the resulting graft is cut from the connective tissue layer.
Ultrasonography (USG) is based on the principle of recording data obtained as a result of
ultrasound waves sent with the help of a probe hitting and reflecting on substances of
different densities. This technique is widely used in medical practice. In dentistry, the USG
method is used to measure the alveolar bone level and the dimensions of the periodontium to
evaluate the gingival thickness. It also has functions to evaluate color power and color
speed, as well as blood flow.
The study hypothesizes that combining SCGT and DGG with a coronally positioned flap could
yield different clinical outcomes in patients with a single buccal gingival recession. This
study aims to compare the clinical success of connective tissue grafts obtained by two
different surgical methods in covering the root surface with ultrasonography (USG).
Description:
The study was planned as a randomized controlled study. Patients with single Miller class 1
or 2 gingival recession who need root coverage surgery in the Department of Periodontology
were included in the study. In combination with Zuchelli's coronally positioned flap
technique, gingival recession in the upper jaw premolar region was treated using a
de-epithelialized gingival graft or a subepithelial gingival graft. The subepithelial
connective tissue graft was obtained in each patient using the single incision technique from
the region between the mesial of the canine and the mesial of the first molar in the palate.
Connective tissue dimensions were approximately 10 X 5 X 2 mm. Finally, the incision line was
sutured with 5/0 synthetic, nonabsorbable, sterile monofilament suture. The de-epithelized
gingival graft was taken in a rectangular shape from the area located on the palatal side of
the maxillary canine and the first molar tooth, and then it was de-epithelized with the help
of a scalpel. After the graft was stabilized to the recipient area with a 5-0 resorbable,
sterile monofilament suture. The flap was repositioned and sutured with 5/0 synthetic,
nonabsorbable, sterile monofilament suture.
Clinical measurements (probing depth (PD), clinical attachment level (CAL), gingival
recession depth and width, keratinized tissue width and height) were taken on the day of
surgery, the 3rd days, the 14th days, the 1st month, the 3rd months and the 6th months.
Patients were evaluated using an ultrasonography device ( MyLabtm Seven, Esaote, Genoa,
Italy) at the Department of Oral and Maxillofacial Radiology.
USG measurements were performed on days 0, 3, 14, 30, 90, and 180 for buccal tissue thickness
and tissue vascularization by an oral and maxillofacial radiologist with at least six years
of experience. A 6-8 MHZ intraoral probe was used in intraoral USG examinations. Steril gel
was applied to the intraoral probe and covered with stretch film. Then, it was placed
directly on the buccal mucosal surface. 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. mean pulsatility index (PI) values of each patient were calculated and
considered for statistical analysis.
The power analysis of the study was performed for sample size calculation. In the power
analysis, when α = 0.05, β = 0.40, 1-β: 0.80, the number of regions to be included in the
study was determined as 20 for each group. The sample size was calculated with a statistical
program.
The data obtained from the study is the 22. version of SPSS. (SPSS Inc., Chicago, IL)
descriptive analysis, means and standard deviations were calculated for all clinical effects,
and USG measurements. Repeated measures analysis of variance was used for intragroup
comparisons before and after treatment. The normality of data distributions of the groups was
measured with the Kolmogorov-Smirnov test. In the comparison of groups, an independent groups
t-test was used if the data distributions were normal, and Mann Whitney U test was used if
the data distribution was not normal. The significance value was taken as p<00.5.m (G*Power;
Universitat, Dusseldorf, Germany).
Read more »
