Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05595772 |
| Other study ID # |
HFMHAElkhe0001 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
August 30, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Minia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinial trial is to detect Which one of two different platelet concentrate
bio-membrane (first or third generation) is better in terms of marginal bone level and bone
density around immediate implants in esthetic zone using Cone beam computerized tomography
The plasma rich in growth factor or concentrated growth factor?
20 patients with nonrestorable maxillary tooth in the esthetic zone, Subjects will be
enrolled
The study will use simple randomization to allocate patients into 2 groups, each group will
be included 10 patients: Group A: (concentrated growth factor group) ten patients indicated
for immediate implant in the maxillary anterior region (class II socket), will be a candidate
for immediate implant placement with CGF combined with xenogeneic bone graft Group B:
(platelet-rich in growth factor group) Ten patients who indicated immediate implant in the
maxillary anterior region (class I or class II socket), will be a candidate for immediate
implant placement with PRGF combined with xenogeneic bone graft.
Description:
with the increasing practice of dental implants; the esthetic outcome is considered as
important as the functional and biological outcome Immediate implants have been evolved as
the first treatment option in cases of the failed tooth to decrease the time of treatment
plan To obtain an effective esthetic outcome with a single implant-supported restoration in
the anterior region, it is crucial to preserve and maintain intact the bone anatomy
Numerous studies have explored the suitability of biocompatible materials in regenerative
medicine. Platelet concentrates are originated from centrifuged blood and are named according
to their biological characteristics, such as platelet-rich plasma, platelet-rich fibrin, and
concentrated growth factor
Plasma rich in growth factors (PRGF), a subtype of P-PRP (pure platelet-rich plasma), is a
supernatant enriched in plasma and platelet-derived morphogens, proteins, and growth factors.
PRGF represents a complex pool of active mediators that may stimulate and accelerate tissue
regeneration, which is generally safe to use and economical to obtain. Autologous PRGF has
been approved for clinical use by the European Community and the U.S. Food and Drug
Administration
CGF (concentrated growth factor), the third-generation platelet concentrate presented by
Sacco in 2006 carries more growth factors and has a firmer fibrin structure than
first-generation PRP and second-generation PRF (platelet-rich fibrin)
Aim of the study is
1. : Assess the effectiveness of PRGF and CGF in the management of buccal dehiscence and
marginal bone level around the immediate implant.
2. : Compare the effectiveness of PRGF Vs CGF.
20 patients with nonrestorable maxillary tooth in the esthetic zone, Subjects will be
enrolled
The study will use simple randomization to allocate patients into 2 groups, each group will
be included 10 patients: Group A: (concentrated growth factor group) ten patients indicated
for immediate implant in the maxillary anterior region (class II socket), will be a candidate
for immediate implant placement with CGF combined with xenogeneic bone graft Group B:
(platelet-rich in growth factor group) Ten patients who indicated immediate implant in the
maxillary anterior region (class I or class II socket), will be a candidate for immediate
implant placement with PRGF combined with xenogeneic bone graft.
Protocol for CGF preparation:
10 ml venous blood samples will be drawn from the patients and placed in a centrifuge tube
without anticoagulants. Then the tubes will be placed in the centrifugation device in an
opposing balanced manner and rotated in four sequential steps. The first step at 735 g (2249
≈ 2200) for 2 min., the second one at 580 g (1998 ≈ 2000) for 4 min., the third one at 735 g
(2249 ≈ 2200) for 4 min. and the fourth one at 905 g (2495 ≈ 2500) for 3 min. The result was
a clot that was collected using a straight tweezer and ready to be used
Protocol for PRGF preparation:
30 ml venous blood will be collected from the patient then deposited in 5 mL tubes containing
sodium citrate anticoagulant. Then the tubes will be centrifuged at 580 G (2270 rpm) for 8
minutes at room temperature. After centrifugation, the blood sample will be layered into the
following four distinctive layers:
1. 0.5 mL Plasma poor in growth factors (PPGFs) =F1 in the uppermost part of the tube
2. 0.5 mL Plasma with growth factors (PGFs) = F2
3. 0.5 mL (PRGF) = F3 located immediately above the red blood cell portion in the tube
4. Red blood cell concentrate layer From all tubes, The 500 μL PPGF will be eliminated and
the PRGF will be separated with 500 μL pipettes and transported to an independent dish
then activated using 50 μL of 10% calcium chloride for every 1 ml of preparation and
mixed with xenogenic bone graft then it will be incubated for 40 minutes in 37̊c to
produce easy to handle gelatinous layer (PRGF) fibrin mixed with the xenogenic bone.
Surgical Phase
1. The surgical site will be prepared by scrubbing the surgical site using Betadine:
Povidone-iodine, 7.5% (0.75% available iodine) the Nile Comp. for Pharmaceuticals and
Chemical Industries, Alexandria, Egypt
2. Nerve block or infiltration anesthesia will be administrated Articaine (4%) with
epinephrine (1:100,000 or 1:200,000)
3. Atraumatic extraction of the tooth or remaining root using periotome, then sequential
implant drilling accompanied by copious irrigation will be carried out. then cover screw
attached to the implant top by the aid of its driver
4. A sample of venous blood will be withdrawn from the patient and centrifuged without
delay according to the preparation protocol of each group.
5. Then the membrane loaded with the bone graft will be applied and condensed around the
dental implant filling the gap between the fixture and the walls of the socket.
6. Finally, Tension-free Closure of the wound was achieved using 4/0 vicryl sutures.
