Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06125938 |
| Other study ID # |
40723 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
July 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Cairo University |
| Contact |
Youmna M Abdelhady |
| Phone |
01066302239 |
| Email |
youmna.abdelhady[@]dentistry.cu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to compare in patients with atrophied anterior maxilla,
bone augmentation techniques ( gold standard bone block and tent pole technique).
The main question it aims to answer is :
Does screw tent pole technique provides better bone gain than autogenous bone block in
atrophied anterior maxilla?
- primary objective to assess amount of bone gain
- secondary objective assess bone quality Participants will be randomly divided into two
groups study group ( tent pole technique) and control group ( bone block) - each group
will be followed up monthly for soft tissue dehiscence and after 6 month to assess bone
gain and bone quality and then implant placement.
Description:
• Research question: Does screw tent pole technique provides better bone gain than autogenous
bone block in atrophied anterior maxilla?
• Rationale for conducting the research: Several methods have been developed for the
augmentation of the deficient bone volume. These include Guided Bone Regeneration (GBR) with
barrier membranes, onlay bone grafting, ridge splitting and distraction osteogenesis.
The screw tent-pole method is an effective technique to achieve initial reconstruction of
alveolar bone deficiencies. Previous studies have proven that screw tent pole technique is
recommended in reconstruction of atrophied alveolar bone and its good outcome in contrary to
other bone graft techniques.
This study aim to compare the outcome of screw tent pole technique to conventional gold
standard technique of block bone grafts in atrophied anterior maxilla.
• Primary and secondary objectives:
- primary objective to assess amount of bone gain
- secondary objective assess bone quality . Trial design: Randomized clinical trial,
Unicentered, Parallel groups, 2 arms, Allocation ratio 1:1, Equivalent trial • PICO:
Population: patients with atrophied Anterior Maxillary area (with initial ridge width of
≤ 5 mm and moderate bone height) Intervention: Screw Tent-Pole technique Control group:
Autogenous Bone Block technique Outcome: bone gain , histomorphometric evaluations,
dehiscence.
- Interventions
- Surgical Protocol
A. Screw Tent pole technique
- A prophylactic antibiotics administration was conducted.
- All surgical procedures were performed under local anesthesia.
- A trapezoid incision will be formed to expose the edentulous alveolar ridge in recipient
site.
- A full-thickness flap will be retracted to expose the alveolar bone. 5
- Titanium screws (1.5 mm) will be placed perpendicular to alveolar bone so that
approximately 5 to 7 mm of screw threat will be exposed.
- A posterior releasing incision was made over ramus to provide access to the donor site.
- Autogenous bone graft taken from donor site area using ACM bur
- The autogenous particles obtained from the donor site will be mixed with xenograft in a
50/50 ratio.
- PRF membrane is then prepared ( PRF membrane formed by withdrawing blood sample from
patient into a tube , the tube will be transferred to centrifuge machine -2500 RPM for
10 minutes) and is pierced through the healing abutment and used to cover the bone graft
to accelerate wound healing by preventing soft tissue ingrowth.
- A tension-free suture will be completed.
- After 6 months of healing:
A full-thickness flap is retracted to expose the alveolar bone (augmented site).
The screw will be removed, Histopathological biopsy sample of bone will be taken using
trephine bur (the same size as pilot drill) and sequential drilling will be done for implant
placement at the same visit.
B. Autogenous bone block technique
- A prophylactic antibiotics administration was conducted.
- All surgical procedures were performed under local anesthesia.
- A trapezoid incision will be formed to expose the edentulous alveolar ridge in recipient
site.
- A full-thickness flap will be retracted to expose the alveolar bone.
- A posterior releasing incision was made over ramus to provide access to the donor site.
- The size of the ramus graft will be determined from the recipient site, and bone
osteotomy of cortical and cancellous bone will be done by Piezo-electric bone surgery.
- The outlined graft was mobilized from its bed using chisels and the bone block will be
placed in defected anterior maxilla and stabilized using micro screws.
- particulate Autogenous bone graft will also be taken from donor site area using ACM bur
and mixed with xenograft in a 50/50 ratio and then placed to fill the space in between
the bone block.
- PRF membrane is then prepared ( PRF membrane formed by withdrawing blood sample from
patient into a tube , the tube will be transferred to centrifuge machine -2500 RPM for
10 minutes) and is pierced through the healing abutment and used to cover the bone graft
to accelerate wound healing by preventing soft tissue ingrowth.
- A tension-free suture will be completed.
- After 6 months of healing:
A full-thickness flap is retracted to expose the alveolar bone (augmented site).
The screw will be removed, Histopathological biopsy sample of bone will be taken using
trephine bur (the same size as pilot drill) and sequential drilling will be done for implant
placement at the same visit.
• Post-operative care:
- Avoid traumatization of the surgical site.
- Patients must abstain from brushing the surgical area. Instead, a disinfecting mouth
rinse should be used (e.g. chlorhexidine 0.2%).
- ·Instruct the patient not to touch or manipulate the surgical area.
- ·Ice packs for 10 minutes every 30 minutes for 24 hours.
- Do not use removable dentures during the expansion phase. Temporary fixed partial
dentures must be adjusted to the expected tissue gain.
- ·No consume of tobacco
- ·Post-operative medications will be prescribed as follows:
- Amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, diclofenac
potassium 50mg every 8 hours for 4 days and then as needed, metronidazole 5 mg/kg every
8 hours for 7 days and chlorhexidine gluconate
- 0.1% mouthwash 3 times daily for 14 days.
Clinical follow up:
-The dehiscence will be followed up every month.
Radiographic follow up:
-Immediately after surgery and after six months, CBCT will be obtained to evaluate bone gain
in each group
