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Guided Island Osteoperiosteal Flap Versus Ridge Splitting for Anterior Atrophic Maxillary

Guided Island Osteoperiosteal Flap Versus Ridge Splitting for Anterior Atrophic Maxillary Augmentation With Implant Placement (a Randomized Controlled Clinical Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07103577
Enrollment
20
Registered
2025-08-05
Start date
2023-11-05
Completion date
2025-05-13
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Alveolar Reconstruction, Virtual Surgical Planning

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.

Interventions

PROCEDUREIsland osteoperiosteal flap

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.

PROCEDUREConventional ridge splitting

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.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain scores1 day, 3rd day and 1 weekPain (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.
Secondary implant stability4 monthsimplant stability was measured using ostell device
Change in bone level (bone gain)Baseline and 4 monthsImmediate 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
Change in bone densitybaseline and 4 monthsBone density at implant body is measured by using computerized tomography values

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026