L- Shape Symphyseal Autogenous Bone Block for Alveolar Ridge Augmentation in Anterior Maxilla and Mandible

NCT05844540 | Completed

• 1 other identifier: A015010222
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of this study was to assess both horizontal and vertical alveolar bone augmentation for sever atrophied anterior maxilla and mandible, using L- shape autogenous bone block harvested from the symphysis. eleven partially edentulous patients seeking horizontal and vertical alveolar bone augmentation in the anterior maxilla or mandible were included in this study. For each patient, autogenous bone block was harvested from the symphysis, trimmed to L-shape and used to augment the anterior maxilla or mandible horizontally and vertically. Horizontal and vertical bone gain was measured by CBCT immediate postoperative and at 6months after grafting.

Conditions

Atrophic Anterior Alveolar Ridge

Keywords

L- Shape autogenous bone block; symphysis; alveolar ridge augmentation; anterior maxilla and mandible

Outcome Measures

Primary Outcomes (5)

• numerical rating scale for pain measurement

  Pain intensity was measured at three days after surgery on a 0 to 10 numerical rating scale in which 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, and 10 = the worst pain imaginable.

  3 days post-surgery

• infection and dehiscence of soft tissue

  This was determined clinically by presence=1 or absence=0, of pus formation or graftb exposure.

  with in 6 months

• questionnaire for sensory disturbance

  This was assessed by patients' complaint (patient questionnaire) to determine any change in subjective sensation in the lower lip, chin and mental area. if there is pain or not. if there is numbness or not.

  with in 6 months

• width of the alveolar ridge

  CBCT cross section view was used for evaluation of alveolar ridge width and preoperatively, immediate postoperative (within one week after grafting), and at 6 months after grafting.

  immediate post-operative and after 6 months

• height of the alveolar ridge

  CBCT cross section view was used for evaluation of alveolar height preoperatively, immediate postoperative (within one week after grafting), and at 6 months after grafting.

  immediate post-operative and after 6 months

Study Arms (1)

harvesting and augmentation of bone block

OTHER

autogenous bone block was harvested from the symphysis, trimmed to L-shape and used to augment the anterior maxilla or mandible horizontally and vertically.

Procedure: harvesting bone block; Procedure: Recipient site preparation; Procedure: implant insertion

Interventions

harvesting bone block PROCEDURE

Under local anesthesia, a sulcular incision was performed between lower right and left second premolars with an oblique incision distal to each one. After that, a full thickness mucoperiosteal flap was elevated to expose the anterior mandible including the entire symphysis and both mental nerves. By using piezo-surgery unit (Surgic Touch, Woodpecker, China), a rectangular bone block was harvested from the symphysis about 8mm in depth and 2mm wider than the recipient site to allow for contouring. The bone cuts were performed 5mm far from the apices of the anterior teeth, mental foramina, and inferior border of the mandible. Finally, thin curved osteotomes was used to detach the bone blocks. The harvested bone block was trimmed to form L-shape block and kept in normal saline. After hemostasis, the flap was closed with 4/0 vicryl interrupted sutures.

Also known as: piezo-surgery block harvesting

harvesting and augmentation of bone block

Recipient site preparation PROCEDURE

At the maxillary recipient site, after induction of local anesthesia, a mid-crestal incision that continued in the sulcus for two teeth on either side of the defect with bilateral oblique incisions were performed. After that, the full thickness mucoperiosteal flap was elevated. While for mandibular recipient site, it was the same flap used for harvesting symphyseal bone block. For both upper or lower recipient sites, perforations (bone marrow penetration) were done to the recipient site by using a fissure surgical bur. The L-shape block graft was trimmed to obtain optimal adaptation to the recipient site, then it was fixed to the residual ridge with two 1.5mm self-tapping titanium screws. After attaining graft stability, any sharp edges were smoothed and any gap between the graft and underlying alveolar bone was filled with particulate bone curetted from the donner site.

harvesting and augmentation of bone block

implant insertion PROCEDURE

Implant insertion: After 6months, the surgical site was opened to remove fixation screws and insert dental implants, and the final restoration was done 4months after implant insertion.

harvesting and augmentation of bone block

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Missed one or more upper or lower anterior teeth.
• alveolar ridge with horizontal and vertical bone loss (class III according to Seibert et al(1983) classification).
• age 18 to 45 years.
• healthy oral mucosa, at least 3 mm keratinized mucosa.
• no systemic diseases or drugs that affect bone healing.
• no systemic or local conditions that contraindicate bone grafting or surgery.

You may not qualify if:

• Patients with disturbed occlusion, inadequate inter-arch space.
• patients with parafunction habits as bruxism or clenching.
• pregnancy.
• smokers.
• poor oral hygiene.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Eldakahlia, 35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: eleven partially edentulous patients seeking horizontal and vertical alveolar bone augmentation in the anterior maxilla or mandible were included in this study. For each patient, autogenous bone block was harvested from the symphysis, trimmed to L-shape and used to augment the anterior maxilla or mandible.

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 6, 2023
• Study Start: February 12, 2021
• Primary Completion: June 5, 2022
• Study Completion: August 21, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)