Clinical trial NCT04133090: Comparison of Autogenous Bone Graft and Screw Tent-Pole Technique on Atrophic Mandible
Official title: Comparison of Treatment Outcomes of Autogenous Block Bone Graft and Screw Tent-Pole Technique in Combination With Injectable Platelet Rich-Fibrin on Posterior Atrophic Mandible: A Split-Mouth Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Loss
Keywords: Bone augmentation
Autogenous block bone graft
Leukocytes and platelet-rich fibrin
Injectable platelet rich fibrin
Tent-pole technique
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth study
Primary purpose: TREATMENT

Brief summary: The purpose of the present study was to assess the effect of injectable platelet-rich fibrin (i-PRF) enriched with allograft on alveolar bone regeneration when compared with autogenous block bone graft, in the same participants.

The study was designed as a split-mouth randomized controlled trial. The patients were randomly assigned to one of two surgical groups: the test group with i-PRF enriched particulate allograft using the screw tent-pole technique; and the control group with autogenous block bone harvested from the ramus area. All augmentation sites covered by leukocytes-PRF (L-PRF) membrane. The primary outcome variable of this study was the radiographic and histologic data collected at postoperative 6 months. The secondary outcome variable was nerve alterations and implant survival.

Detailed description: Alveolar bone loss which results from tooth extraction, trauma or age-related factors, gives rise to the functional or structural inefficiency of implant-supported prosthetic rehabilitation. Therefore, bone augmentation techniques and graft materials are required to improve esthetic outcomes and long-term prognosis of dental implant treatment. The purpose of the present study is to evaluate the effect of i-PRF enriched with allograft on bone regeneration when compared with autogenous block bone graft. The hypothesis of the study is that i-PRF enriched with allograft will provide similar results to autogenous block bone graft for three dimensional bone reconstruction. This split-mouth randomized study was conducted in the Department of Oral Surgery of the School of Dentistry. The research protocol and informed consent forms for all procedures on patients, were approved by the local ethics committee of the University in accordance with the Helsinki Declarations of 1983.Selection of the participants was determined by clinical and radiological examination according to the inclusion criteria.Before augmentation surgery, the treatment allocation of bilateral posterior atrophic mandibles were randomly assigned to one or other of the two surgical sides: either the test group ( i-PRF + particulate allograft with screw tent-pole technique + L-PRF) or the control group (autogenous block bone graft + L-PRF) by use of the computer-generated method. Blood samples from thirteen participants were collected by a nurse at the beginning of the surgery.The L-PRF preparation was performed as follows; the venous blood samples were collected in 9 ml x 4 glass tubes without anticoagulant and immediately centrifuged at 2700 rpm for 12 min. After the centrifugation of the samples, the red blood cells (RBC) and platelet-poor plasma (PRP) were separated from the 'buffy coat' described as L-PRF. Then the L-PRF was placed on a special press kit to obtain membrane form.

Non-coated, 8 ml plastic tube without anticoagulant was immediately centrifuged at 2700 rpm for 2 min to obtain i-PRF. Following centrifugation, i-PRF was collected the tube by using a disposable syringe and mixed with allograft material. All surgeries were performed under local anesthesia. A mid-crestal incision was made on either side to expose the edentulous alveolar ridge. Furthermore, a posterior releasing incision was made over the external oblique ridge to provide access to the donor site, in control group.

Control site was treated with autogenous block bone graft and the opposite side (test site) was treated with I-PRF enriched allograft material. L-PRF membrane was used to cover augmentation sites.

The primary outcome variables of this study were the radiographic changes of augmented bone at postoperative 6 months as well as the percentage of newly formed bone, graft material and residual bone in the groups.

The secondary outcome variables were the clinical data on implant survival rate and nerve alterations.

Eligibility criteria: Inclusion Criteria:

* Patients who refused to use a partially removable prosthesis and requested dental implant treatment,
* Patients had bilateral, moderate or severe posterior atrophic mandible,
* Patients had precluded conditions suitable for short dental implant.

Exclusion Criteria:

* Patients who had systemic diseases (osteoporosis, hemophilia, anemia, etc.),
* Patients who required drugs (bisphosphonate or steroid therapy),
* Patients who had a smoking habit,
* Patients who had received radiation therapy within the last two years,
* Patients who were under 18 years old, pregnant or lactating,
* Patients who had a total platelet count lower than 150,000/mm3.

Primary outcomes:
measure: Assessment of radiological changes
timeFrame: Change of alveolar bone height at 6 months
measure: Histological assessment
timeFrame: Postoperatively 6 months
Secondary outcomes:
measure: Clinical assessment
timeFrame: 6 months, 12 months
measure: Clinical assessment
timeFrame: 1 month, 6 months, 12 months
Other outcomes:
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