NCT07103577

Brief Summary

Background: After tooth extraction changes of the shape of the alveolar bone follows a predictable pattern, which proves to be challenging in restoring its form and function, especially in the esthetic zone. Autogenous grafts remain the gold standard because of their predictability. The island osteoperiosteal flap (I-flap) is introduced as a modified alveolar split bone grafting technique used to gain width, height and modify the facial or buccal bone plate position. Aim of the study: This study aims to evaluate in anterior atrophic maxillary ridge augmentation using guided unreflected island osteoperiosteal flap (I-Flap) approach with simultaneous implant placement and interpostional bone grafting in comparison to computer guided ridge splitting method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

July 29, 2025

Last Update Submit

July 29, 2025

Conditions

Maxillary Alveolar ReconstructionVirtual Surgical Planning

Outcome Measures

Primary Outcomes (4)

  • Change in pain scores

    Pain (by Visual Analogous Scale): Score 0 - No pain. Scores 1 to 3 - Mild pain. Scores 3 to 7 - Moderate pain. scores 7 to 10 - severe pain.

    1 day, 3rd day and 1 week

  • Secondary implant stability

    implant stability was measured using ostell device

    4 months

  • Change in bone level (bone gain)

    Immediate post-operative CBCT (T1) will be done to measure the alveolar bone gain, to assess the proper implant positioning, and finally to measure the width of the out-fractured buccal plate and the amount of interpositional bone graft. Four months postoperatively CBCT (T2) will be done to measure amount of bone gain

    Baseline and 4 months

  • Change in bone density

    Bone density at implant body is measured by using computerized tomography values

    baseline and 4 months

Study Arms (2)

Computer guided island flap

EXPERIMENTAL
Procedure: Island osteoperiosteal flap

Computer guided conventional ridge splitting

ACTIVE COMPARATOR
Procedure: Conventional ridge splitting

Interventions

Island osteoperiosteal flapPROCEDURE

Crestal incision using no. 15 blade on a bard parker no. 3. Two blind lateral vertical ostotomies at about 1.5 to 2 mm from the adjacent tooth roots to preserve subpapillary and root bone coverage. These cuts are to ensure the complete fracture of buccal plate while being attached to the overlying periosteum.

Computer guided island flap
Conventional ridge splittingPROCEDURE

Crestal incision and 2 vertical releasing incisions will be made using a no.15 blade mounted on a Bard Parker no.3. Then, a full mucoperiosteal flap reflection to expose bone.

Computer guided conventional ridge splitting

Eligibility Criteria

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

You may qualify if:

  • Patient seeking replacement of a missed maxillary anterior tooth by a delayed dental implant procedure.
  • Residual bone height is (8-15) mm and (3-4) mm alveolar bone width.
  • Good oral hygiene.

You may not qualify if:

  • Uncontrolled Diabetes.
  • Coagulation disorders.
  • Immunological disorders.
  • Previous radiation of the head and neck region.
  • Abnormal bone physiology.
  • Therapy with Bisphosphonates.
  • Heavy smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Location

Related Publications (1)

  • Salem OAEH, Elmahlawy AS, Saber ME. Evaluation of 3-Dimensional accuracy of guided implant placement using guided osteoperiosteal flap versus guided ridge splitting for atrophic maxillary augmentation (a randomized clinical trial). BMC Oral Health. 2025 Dec 5;25(1):1905. doi: 10.1186/s12903-025-07364-6.

    PMID: 41350657DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 5, 2025

Study Start

November 5, 2023

Primary Completion

May 13, 2025

Study Completion

May 13, 2025

Last Updated

August 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)