NCT06450535

Brief Summary

Two groups of patient with horizontally deficient anterior maxilla indicated for bone augmentation ,one will be subjected to autogenous onlay bone block from retromolar bone and the other to cortical shell from retromolar bone also.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

1.4 years

First QC Date

May 9, 2024

Last Update Submit

June 7, 2024

Conditions

Keywords

Autogenous onlay bone blockCortical shell technique

Outcome Measures

Primary Outcomes (1)

  • radiographic analysis

    calculation of bone width gain using cone beam computed tomography

    4 month postoperative

Secondary Outcomes (1)

  • histomorphometric analysis

    4 months postoperative

Study Arms (2)

Autogenous onlay block from retromolar bone

EXPERIMENTAL

In the first intervention, a bone block harvested from the donor site was fixed with osteosynthesis titanium screws to the recipient site as an onlay graft to achieve a horizontal enlargement of the alveolar ridge. ● Placement of the bone graft was always guided by an augmentation template

Procedure: Autogenous onlay bone block harvesting from retromolar bone in anterior maxilla

Cortical shell technique from retromolar bone

ACTIVE COMPARATOR

The harvested cortical plate was then split longitudinally in two parts using a microsaw, and thinned with the bone scraper to achieve a plate of 1 mm thickness. * The plate was fixed at a distance from the residual ridge with 2 screws. * Autogenous bone particles, collected with the bone scraper, were tightly packed into the gap between the plate and the recipient site.

Procedure: Autogenous cortical shell technique from retromolar bone in anterior maxilla

Interventions

Surgical protocol ( retromolar bone harvesting) After injecting local anesthesia a crestal incision is done, from a point on the occlusal surface along the external oblique ridge and extending anteriorly and inferiorly through the buccal mucosa, parallel to the gingival margin of the mandibular molars. The subperiosteal dissection extend to expose the ascending ramus and the retromolar region With the aid of surgical carbide burs, two proximal vertical cuts penetrating the cortex of the external oblique ridge. The depth of penetration of the posterior cut did not exceed 2.5 mm to avoid injury to the inferior alveolar nerve. By using microsaw , an inferior cut of 3.2 mm in depth joining the anterior and posterior vertical cuts was done. Small perforations of 3-4 mm in depth were performed on the superior aspect of the external oblique ridge using 1 mm drill bur. Finally, the block was sheared off using a chisel.

Also known as: Autogenous onlay block from retomolar bone
Autogenous onlay block from retromolar bone

The harvested cortical plate was then split longitudinally in two parts using a microsaw, and thinned with the bone scraper to achieve a plate of 1 mm thickness. The plate was fixed at a distance from the residual ridge with 2 screws. Autogenous bone particles, collected with the bone scraper, were tightly packed into the gap between the plate and the recipient site.

Also known as: Cortical shell technique from retromolar bone
Cortical shell technique from retromolar bone

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients in both sex with partial edentulism of the maxilla and requiring horizontal ridge augmentation
  • The ages of the patients ranged from 20 to 60 years.
  • The residual ridge width in these patients are less than 4.m
  • Sufficient bone in intra-oral donor sites are available (external oblique ridge)
  • Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
  • The vertical level should be in a favourable esthetic appearance with normal inter-arch space
  • The minimum number of missing teeth in the anterior maxilla alveolar ridge is one single extracted teeth

You may not qualify if:

  • Subjected to irradiation in the head and neck area less than 1 year before implantation.
  • Poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnant or nursing.
  • Substance abuse.
  • Psychiatric problems or unrealistic expectations.
  • Severe bruxism or clenching.
  • Immunosuppressed or immunocompromised.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of oral and dental medicine ,Cairo university

Cairo, Giza Governorate, 12613, Egypt

RECRUITING

Related Links

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • mohamed atef, PhD

    faculty of oral and dental medicine,cairo university

    STUDY DIRECTOR

Central Study Contacts

maria ibrahim nageeb, BSc

CONTACT

maria ibrahim nageeb, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This trial is considered a randomized single blind clinical trial due to the following: * The participants will be blinded to the technique that will be used during the surgical procedure. * The operator will not be blinded for both techniques during the surgical procedure as the two techniques are different. * The outcome assessor cannot be blinded. C) Data collection, management, and analysis:
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomzed cinical trial A trial will be caried out in hosptal of Oral and Maxllolacial surgery department- Faculy of Oral and Dental Medicine Cairo Univerity. Equal randomizaion: participants wih equal probabilites for intervenion Postive controlled :Both groups receiving treatment Parallel group study: Each group of patients receives a single treatment simutaneously
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 9, 2024

First Posted

June 10, 2024

Study Start

July 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

June 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations