Accuracy of Guided Ridge Splitting With Simultaneous Implant Placement

NCT ID: NCT06333912

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-02
• Study Completion Date: 2024-02-27

Brief Summary

Assessing whether is there a difference between computer-guided ridge splitting and conventional technique with simultaneous implant placement in patients with maxillary width deficiency.

Detailed Description

Two groups one treated with ridge splitting using guided surgery and the other one treated with freehand surgery and both groups had simultaneous dental implants the first one had guided placement and the other one was freehand.

Conditions

Dental Implant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

study group treated with guided ridge splitting.

virtual surgical planning using planning software Blue Sky Bio (BSB) and 3D printed surgical guide are fabricated to guide the ridge splitting procedure and implant drilling and placement.

Group Type: EXPERIMENTAL

dental implant placement with ridge splitting.

Intervention Type: PROCEDURE

ridge splitting to increase bone width in atrophic maxilla with simultaneous implant placement

control group treated with conventional ridge splitting.

Freehand surgery is done including ridge splitting and implant plaement

Group Type: ACTIVE_COMPARATOR

dental implant placement with ridge splitting.

Intervention Type: PROCEDURE

ridge splitting to increase bone width in atrophic maxilla with simultaneous implant placement

Interventions

dental implant placement with ridge splitting.

ridge splitting to increase bone width in atrophic maxilla with simultaneous implant placement

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient with missing maxillary anteriors or premolars teeth.
• Tooth extraction at the implant sites was performed at least 4 months before the surgery.
• The bone width of the crestal one -third (3-5 mm) with sufficient bone height allowing for simultaneous implant placement.
• Free from any systemic disease or local pathological lesions that may affect bone healing or contraindicate implant placement.
• With no history of any previous grafting surgeries at the area of interest.

Exclusion Criteria

• Sever concavity of the alveolar ridge.
• Bad oral hygiene ( Silness-Löe index (score 2-3).
• Heavy smoker (smoke greater than or equal 25 cigarettes per day).
• Presence of acute infections or periapical lesions in adjacent teeth.
• Parafunctional habits.
• Pregnant females.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahmoud Elbayaa

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

Alexandria University, Faculty of dentistry

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

ridgesplittingguided

Identifier Type: -

Identifier Source: org_study_id