Comparison of Autogenous Bone Graft and Screw Tent-Pole Technique on Atrophic Mandible

NCT04133090 | Completed

• 1 other identifier: Dentistry
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alveolar Bone Loss

Keywords

Bone augmentation; Autogenous block bone graft; Leukocytes and platelet-rich fibrin; Injectable platelet rich fibrin; Tent-pole technique

Outcome Measures

Primary Outcomes (2)

• Assessment of radiological changes

  Radiologic analysis was performed to compare the changes in height of alveolar bone between the study groups

  Change of alveolar bone height at 6 months

• Histological assessment

  Bone core samples were harvested from the implant placement sites for calculate the relative quantification of newly-formed bone within both groups as a percentage

  Postoperatively 6 months

Secondary Outcomes (2)

• Clinical assessment

  6 months, 12 months

• Clinical assessment

  1 month, 6 months, 12 months

Study Arms (2)

Autogenous block bone graft

ACTIVE COMPARATOR

Surgical site as control group was treated with autogenous block bone graft. Augmentation site was covered with a mixture of particulate allograft and leukocyte and platelet-rich fibrin (L-PRF) membrane.

Procedure: Autogenous block bone graft

i-PRF enriched allograft material+screw tent pole technique

ACTIVE COMPARATOR

Surgical site as test group was treated with injectable platelet rich-fibrin (i-PRF) enriched allograft material. To avoid soft tissue collapse, screws were used. Augmentation site was covered with leukocyte and platelet-rich fibrin (L-PRF) membrane.

Procedure: i-PRF enriched allograft material+ screw tent pole technique

Interventions

Autogenous block bone graft PROCEDURE

Vertical and horizontal osteotomies were performed by means of a 6-mm diameter separation disc under copious irrigation with saline.The harvested bone graft was immediately placed in sterile saline solution to prevent dehydration. Sharp edges around the block graft were rounded under saline irrigation using a 4-mm round bur. The screw holes were properly made on both the recipient site and the block graft using a 1.3 mm drill. The graft was firmly fixed with 1.3 mm screws and a compatible driver. The periphery of the graft and the underlying gap between the screws and the recipient site, were covered with a mixture of particulate allograft and sterile saline solution to minimize resorption and to improve the adaption of the graft. All augmentation sites were covered by L-PRF membrane and flap closure was effected with 4/0 silk suture.

Autogenous block bone graft

i-PRF enriched allograft material+ screw tent pole technique PROCEDURE

The i-PRF preparation was performed as follows: the blood sample collected in an 8 ml, non-coated plastic tube without anticoagulant was immediately centrifuged at a protocol of 2700 rpm for 2 min. After centrifugation, the liquid autologous fibrin material which comprised the 1 mL upper layer of the tube was collected, using a disposable syringe. The screw holes were made on the recipient site using a 1.3 mm drill. 7 mm long screws were fixed 2mm or 4mm higher than on the recipient site to provide the desired augmentation distance and stabilized by a compatible driver. i-PRF was mixed with allograft material in a sterile metal box. Polymerization was done in 3 to 5 minutes, then this material was applied to the underlying gap between the screws and the recipient site.All augmentation sites were covered by L-PRF membrane and flap closure was effected with 4/0 silk suture.

i-PRF enriched allograft material+screw tent pole technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Split-mouth study

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 21, 2019
• Study Start: April 11, 2016
• Primary Completion: October 8, 2018
• Study Completion: July 6, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share