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Completed

NCT Number: NCT07103577

Guided Island Osteoperiosteal Flap Versus Ridge Splitting for Anterior Atrophic Maxillary

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.

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Key information

Conditions

Maxillary Alveolar Reconstruction Virtual Surgical Planning

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Azarita, 00203, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Island osteoperiosteal flap

Procedure

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.

Conventional ridge splitting

Procedure

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.

Primary outcomes

  1. Change in pain scores

    Time frame: 1 day, 3rd day and 1 week

    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.

  2. Secondary implant stability

    Time frame: 4 months

    implant stability was measured using ostell device

  3. Change in bone level (bone gain)

    Time frame: Baseline and 4 months

    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

  4. Change in bone density

    Time frame: baseline and 4 months

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

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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