Accuracy of Guided Ridge Splitting With Simultaneous Implant Placement

NCT06333912 | Completed

• 1 other identifier: ridgesplittingguided
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant

Keywords

guided ridge splitting, atrophic maxilla, osseodensification drills.

Outcome Measures

Primary Outcomes (1)

• Assessing the accuracy of guided surgery

  superimposition of post-op cbct to the planned position to check the accuracy of implant positions.

  one week

Secondary Outcomes (1)

• the bone-width increase between control and study group.

  6 months

Study Arms (2)

study group treated with guided ridge splitting.

EXPERIMENTAL

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.

Procedure: dental implant placement with ridge splitting.

control group treated with conventional ridge splitting.

ACTIVE COMPARATOR

Freehand surgery is done including ridge splitting and implant plaement

Procedure: dental implant placement with ridge splitting.

Interventions

dental implant placement with ridge splitting. PROCEDURE

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

control group treated with conventional ridge splitting.; study group treated with guided ridge splitting.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University, Faculty of dentistry

Alexandria, 21619, Egypt

Location

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases

Study Officials

• Mahmoud Elbayaa

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 27, 2024
• Study Start: August 2, 2023
• Primary Completion: January 29, 2024
• Study Completion: February 27, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

EG (1)