NCT06089928

Brief Summary

The atrophatic anterior maxilla present a considerable challenge for both surgical and prosthetic rehabilitation, as it may require bone augmentation to enable implant placement. The techniques proposed for vertical augmentation of the alveolar ridge include distraction osteogenesis, only grafting, and sandwich osteoplasty. Sandwich osteotomy is reported to provide more stable and predictable results with respect to the height of the alveolar ridge. The main advantage of osteotomy techniques that employ Interpositional bone grafts is reported to be the improved blood supply in the augmented region.

Trial Health

43
At Risk

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 Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

October 10, 2023

Last Update Submit

October 18, 2023

Conditions

Vertical Ridge DeficiencyAtrophic Maxilla

Keywords

sandwich osteotomyvertical augmentation,aesthetic zoneInterpositional graftfixation free

Outcome Measures

Primary Outcomes (2)

  • radiographical bone gain

    amount of vertical bone gain in millimeter using cone beam CT scan

    4-months

  • radiographical bone change

    amount of bone change in millimeter using cone beam CT scan

    4- months

Secondary Outcomes (4)

  • clinical pain

    1-3days

  • clinical edema

    1-7 days

  • clinical infection

    1-5 days

  • clinical dehiscence

    1-30 days

Study Arms (2)

fixation free

ACTIVE COMPARATOR

sandwich osteotomy with Interpositional graft without fixation.

Procedure: vertical augmentation

conventional sandwich osteotomy

ACTIVE COMPARATOR

sandwich osteotomy with Interpositional graft with fixation.

Procedure: vertical augmentation

Interventions

vertical augmentationPROCEDURE

sandwich osteotomy with an Interpositional inlay graft

Also known as: segmental osteotomy with Interpositional graft
conventional sandwich osteotomyfixation free

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both sex
  • Adulte patient (18-60 y.)
  • Highly motivated patient with good oral hygiene
  • No systematic diseases or conditions known to alter bone healing.
  • No local pathosis that may interfere with bone healing.
  • No recent history of augmentation procedure at the same area.
  • Criteria of the edentulous ridge:
  • The anterior maxillary vertical dimension is minimum 10mm, measured from the crest of the ridge to the nasal floor.
  • Horizontal ridge dimension remains normal; at least 6mm.
  • The minimum number of the missing teeth is minimum 2 teeth and the maximum will be the six anteriors.
  • There will be increased inter-arch space compared with the adjacent teeth.

You may not qualify if:

  • uncontrolled Diabetes mellitus (DM)
  • pregnancy
  • uncontrolled local factors(periodontitis), or acute infection related to the aera.
  • smoking: more than 20 cigarettes \\day
  • intravenous bisphosphonate
  • patients who had received radiation treatment in the head and neck region.
  • previous bone augmentation in the site within 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, 3753450, Egypt

Location

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesMaxillary DiseasesJaw DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
both the participant and outcome assessor would not know to which group of study they belong investigator can not be masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: clinical and radiographical comparisons of newly formed bone following vertical ridge augmentation which is achieved by use sandwich osteotomy with Interpositional inlay graft (ramus block) without fixation (test group), and same procedure with using micro-plates and screws as a mean of fixation (control group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 19, 2023

Study Start

January 1, 2024

Primary Completion

June 30, 2025

Study Completion

January 30, 2026

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

all collected individual participant data including diagnosis, treatment plane, surgical intervention, outcome assessment, results will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
4-months follow-up
Access Criteria
open

Locations

EG(1)