Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04821804 |
| Other study ID # |
JordanUST6 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
January 2, 2020 |
| Est. completion date |
September 5, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Jordan University of Science and Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A total of 24 healthy non-smoker patients requiring FGG recruited for the study. Subjects
were equally and randomly assigned into two groups. Test group, local application of HYADENT
BG on both donor and recipient sites. Control group, application of normal saline on both
sites as placebo. The FGG dimensions were evaluated at 1, 3- and 6-month recall using digital
photographs. Post-operative pain was evaluated for 14 days. Color matching and patient
satisfaction were evaluated at 6 months.
Description:
The study was approved in the Institutional Review Board (IRB) at Jordan University for
Science and Technology and Jordanian Food and Drug Administration. This clinical trial was a
single-centre, parallel-group, prospective, randomized, subject-blind placebo-controlled
study of Hyaluronic Acid (HYADENT BG), and placebo in patients undergoing FGG who met the
inclusion criteria. The study was performed in accordance with the International Conference
on Harmonization Good Clinical Practice and CONSORT guidelines.For all patients included in
the study, phase I periodontal therapy was completed 4 weeks pre-surgically. All Patients
were instructed to gargle with anti-microbial chlorohexidine mouth 0.2% for one minute
pre-surgically to eliminate any source of infection. local anesthesia injection by 2%
lidocaine with 1:100 000 epinephrine was given into the depth of the vestibule.
On the recipient site, coronal incision was made horizontally at the level of MGJ on the
teeth to be treated and passing the midpoint of the adjacent teeth, at right angle 90 degree
to the Mesio-angle and Disto-angle to the papilla to create "Butt joint" margin. The
recipient sites had even thickness of the flap, then the flap was repositioned apically On
the palatal donor site, custom tinfoil template was placed over the palatal mucosa to outline
the dimensions of the graft according to the recipient bed. The area that chosen to harvest
the graft was between first premolar and first molar and located 2 mm distant from the
gingival margins of the corresponding teeth. After harvesting the FGG, Photograph was taken
immediately to measure the graft area at the baseline. Connective tissue surface was
carefully inspected for irregularities or adipose tissue after graft separation to minimize
dead space between the graft and the recipient bed and enable quick revascularization of the
graft. Graft thickness was immediately confirmed with a digital caliber at 5 points (four
corners and center of the graft) and, if necessary, the graft was prepared (thinned) while
holding it on sterile tongue depressor to obtain a graft approximately 1 to 1.3 mm thick.
For donor site closure, in the test group, application of HYADENT BG on the donor site and
injection of HYADENT BG in collagen sponge that was placed over the site, then figure X
sutures to close the area using (4-0 polyglycolic acid/ reverse cutting/ 12 mm) resorbable
sutures. On the other hand, control group donor sites were washed with normal saline and
placing the collagen sponge that soaked in normal Saline on the donor site. For both donor
tested and control sites, a collagen sponge and figure X -0 resorbable sutures were placed.
Finally, covering the donor areas in both groups with Septo-pack gingival dressing
(Septodont, Saint Maur-des-fosses, France) then X suture over the pack to prevent the
displacement of pack (Figure 1a,b).
For the graft stabilization, in the study group, application of HYADENT BG on the surgical
site and the borders also was established. On the other hand, control group recipient bed was
washed with normal saline before the graft placement. Minimal and fixed number of sutures was
used for stabilization of the FGG as described previously by (Sullivan, 1968). 11
Magnification using Dental magnification loupe (3.5X- 420mm) was used to obtain the graft
stabilization by sutures. Graft stabilized in both groups using (6-0 polyglycolic acid/
reverse cutting/ 12 mm suture) with two simple interrupted sutures in the coronal portion of
the two Apico-coronal edges, and one suture in the mid-point of the coronal border using
simple interrupted method. One Periosteal Oschenbein suture (4-0 polyglycolic acid/ reverse
cutting/ 12 mm suture) to fix the graft on its place. In the study group, the operator
topically applied the HYADENT BG on the borders of the graft after stabilization. On the
other hand, in control group, operator topically applied normal saline on the bed before
stabilization of the graft as placebo. Finally, after stabilization, gentle pressure was
applied to the graft for five minutes in both groups to stabilize the clot under the graft
Clinical photographs Clinical photographs were used to measure the surface area of the graft
in all follow up periods, and to assess the color matching between the grafted area and the
adjacent tissue at the end of the final follow-up visit on 6-month period. All intra oral
photographs were taken with the same professional camera (Nikon D3400) with same intraoral
photographs setting (Aperture 32, Shutter speed 1/160, ISO 100), professional macro lens
(Sigma 105mm f/2.8 EX DG OS HSM Macro Lens), ring flash (Godox Macro Ring Flash ML-150) with
½ light exposure. Fixed distance between the chin of the patient and the ring flash was
considered to take the photograph was 30 cm. Lip retractor was used to allow uniform lighting
of the area, and using Michigan "O" periodontal probe parallel with adjacent teeth as a
reference (known distance between two fixed points) for measuring the graft area using the
digital software.
Postoperative protocol The post-operative care aimed at maintaining wound stability.
Post-operative instructions included ceasing tooth brushing and flossing around the surgical
sites until the day of periodontal sutures removal (day 14). However, Patients were directed
to start brushing their teeth expect the experimental area (canine to canine) after one week
and to eat only soft foods during the first week and to avoid any mechanical or thermal
trauma. No antibiotics nor analgesics were prescribed. Patients were followed professionally
by the same periodontist (S.K), scheduled to be seen on month 1, 3, and 6 months.
Parameters Visual analogue scale (VAS) was used to evaluate the pain for two weeks
postsurgical period. A two separates 10 cm VAS with 'no pain' at the left and 'unbearable
pain' at the right end as verbal end points. Two forms for each day, one for the recipient
site and one for the donor site. Forms were given to subjects after completion of the
operation and they asked to mark the pain value they feel at the end of each day. Forms were
collected on the day of suture removal (day 14).
The color matching between the graft and the adjacent tissue was determined and compared by
using professional evaluation at the end of the final post-operative follow up visit (6
months). Two blinded examiners through Visual Analog Scale (VAS). Actually, VAS is a scale
for measurement of subjective features, which are difficult to measure. The test and control
areas were assessed for color matching of the grafted tissue with the adjacent keratinized
gingiva between canines area. The results were esthetically graded in three groups of Poor
[1-3], Moderate [4-6] and Good [7-9].
Patient's Satisfaction was measured by scale from 0 to 10 was filled by each patient where 0
is not satisfied, Little satisfied [1-3], Average satisfied [4-6] and highly satisfied [7-10]
is fully satisfied by the outcome, this reading was recorded only at the end of the study 6
months post-surgically.
graft area measurement was performed with Java-based analyse programme (ImageJ, National
Institutes of Health, Bethesda, Maryland, USA). For evaluation of the graft area, graft
borders were drawn after inserting the known distance between two fixed points on periodontal
probe (10 mm) by the number of pixels between these two points. All evaluations were repeated
twice, and the average value of these two measurements was calculated at 1-, 3-, and 6- month
follow-ups.
