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

Primary Purpose

Atrophic Anterior Alveolar Ridge

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
harvesting bone block
Recipient site preparation
implant insertion
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Anterior Alveolar Ridge focused on measuring L- Shape autogenous bone block, symphysis, alveolar ridge augmentation, anterior maxilla and mandible

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dentistry, Mansoura University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

harvesting and augmentation of bone block

Arm Description

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

Outcomes

Primary Outcome Measures

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.
infection and dehiscence of soft tissue
This was determined clinically by presence=1 or absence=0, of pus formation or graftb exposure.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 13, 2023
Last Updated
April 25, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05844540
Brief Title
L- Shape Symphyseal Autogenous Bone Block for Alveolar Ridge Augmentation in Anterior Maxilla and Mandible
Official Title
L- Shape Symphyseal Autogenous Bone Block for Alveolar Ridge Augmentation in Anterior Maxilla and Mandible
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
June 5, 2022 (Actual)
Study Completion Date
August 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
A total of 11 partially edentulous patients needing extensive horizontal and vertical bone augmentation in the anterior maxilla or mandible were included in this study. The patients were recruited from the Outpatient Clinic of Oral and Maxillofacial Department, Faculty of Dentistry, Mansoura University. Before the surgical operation, all patients were informed about the treatment options, the nature of the operation, and the probable postoperative sequelae. An informed consent was signed from each patient. Preoperative assessment Patients' medical status were carefully evaluated. A thorough intraoral examination was done to evaluate oral hygiene, occlusion, and mucosa that covers the recipient and donor sites. Preoperative CBCT was done for each patient to evaluate bone width and height in both the recipient and donor sites. Surgical procedures Prophylactic antibiotic 600 mg Clindamycin (Clindam, Sigma, Egypt) was administered 1 hour before surgery. A thorough mouth rinsing using Chlorhexidine mouth wash (Hexitol, Adco, Egypt) for about 1 min was done immediately before surgery. Harvesting procedure of the symphysis bone block: 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, 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. Recipient site preparation: 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. Finally, the flap was relaxed by periosteal incisions and blunt muscle dissection from the anterior maxilla or mandible to obtain a primary tension free closure using 4/0 vicryl interrupted and horizontal mattress sutures. Postsurgical instructions: Patients were instructed to avoid any wound trauma, and apply ice packs on the host and recipient surgical sites 20min/ hour for the first day after surgery. Proper oral hygiene should be maintained by mouth rinsing with chlorhexidine mouth wash 3times/ day for 1 week. Diclofenac potassium 50mg (Cataflam, Novartis, Switzerland) anti-inflammatory analgesic was prescribed as needed. Clindamycin 300mg twice daily was prescribed for 7days. 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. Evaluation: the patients were scheduled at 3days, 14days, 3months, and 6months postoperatively to evaluate:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Anterior Alveolar Ridge
Keywords
L- Shape autogenous bone block, symphysis, alveolar ridge augmentation, anterior maxilla and mandible

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
harvesting and augmentation of bone block
Arm Type
Other
Arm Description
autogenous bone block was harvested from the symphysis, trimmed to L-shape and used to augment the anterior maxilla or mandible horizontally and vertically.
Intervention Type
Procedure
Intervention Name(s)
harvesting bone block
Other Intervention Name(s)
piezo-surgery block harvesting
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Recipient site preparation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
implant insertion
Intervention Description
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.
Primary Outcome Measure Information:
Title
numerical rating scale for pain measurement
Description
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.
Time Frame
3 days post-surgery
Title
infection and dehiscence of soft tissue
Description
This was determined clinically by presence=1 or absence=0, of pus formation or graftb exposure.
Time Frame
with in 6 months
Title
questionnaire for sensory disturbance
Description
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.
Time Frame
with in 6 months
Title
width of the alveolar ridge
Description
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.
Time Frame
immediate post-operative and after 6 months
Title
height of the alveolar ridge
Description
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.
Time Frame
immediate post-operative and after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients with disturbed occlusion, inadequate inter-arch space. patients with parafunction habits as bruxism or clenching. pregnancy. smokers. poor oral hygiene.
Facility Information:
Facility Name
Faculty of Dentistry, Mansoura University
City
Mansoura
State/Province
Eldakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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