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Clinical Trials/NCT05844540
NCT05844540CompletedNot Applicable

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

Mansoura University1 site in 1 country11 target enrollmentStarted: February 12, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
11
Locations
1
Primary Endpoint
numerical rating scale for pain measurement

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.
  • •poor oral hygiene.

Arms & Interventions

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.

Intervention: Recipient site preparation (Procedure)

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.

Intervention: harvesting bone block (Procedure)

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.

Intervention: implant insertion (Procedure)

Outcomes

Primary Outcomes

numerical rating scale for pain measurement

Time Frame: 3 days post-surgery

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.

questionnaire for sensory disturbance

Time Frame: with in 6 months

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.

infection and dehiscence of soft tissue

Time Frame: with in 6 months

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

width of the alveolar ridge

Time Frame: immediate post-operative and after 6 months

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

Time Frame: immediate post-operative and after 6 months

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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