Crestal Sinus Lifting in Periodontally-Compromised Patients Utilizing Autologous Dentin Graft

NCT06887582 | Active Not Recruiting DMC

• 1 other identifier: KFSIRB200-475
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The integration of artificial intelligence and computer-guided technology offers the potential for improving surgical accuracy, reducing complications, and enhancing outcomes. Additionally, advancements such as electromagnetic mallets for bone manipulation and autologous dentin grafts provide promising alternatives for bone regeneration. This study aims to combine these technologies to assess the efficacy and clinical outcomes of AI-assisted, computer-guided crestal sinus lifting with immediate implant placement in periodontally compromised sites.

Conditions

Maxillary Sinus Disease; Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• Bone gain

  CBCT scans will be captured and the distance from the crestal bone to the sinus boundries will be measured

  12-month.

Study Arms (4)

study group I

EXPERIMENTAL

Free-hand crestal sinus lifting with particulate autologous dentin graft and free-hand implant placement

Procedure: Free-hand sinus lift augmanted by particulate autologous dentin graft + free-hand implant placement

study group II

EXPERIMENTAL

AI-assisted/computer-guided crestal sinus lifting with particulate autologous dentin graft and computer-guided implant placement.

Procedure: AI-assisted/computer-guided sinus lift augmanted by particulate autologous dentin graft + computer-guided implant placement

study group III

EXPERIMENTAL

Free-hand crestal sinus liftingwith autologous dentin block graft and free-hand immediate implant placement

Procedure: Free-hand sinus lift with autologous dentin block graft +free-hand immediate implant placement

study group IV

EXPERIMENTAL

AI-assisted/computer-guided crestal sinus liftingwith autologous dentin block graft and computer-guided immediate implant placement.

Procedure: AI-assisted/computer-guided sinus lift with autologous dentin block graft +computer-guided immediate implant placement.

Interventions

Free-hand sinus lift augmanted by particulate autologous dentin graft + free-hand implant placement PROCEDURE

The sinus will be lifted and augmented by particulate autologous dentin graft followed by simultaneous free-hand implant placement

study group I

AI-assisted/computer-guided sinus lift augmanted by particulate autologous dentin graft + computer-guided implant placement PROCEDURE

The sinus will be lifted and augmented by particulate autologous dentin graft followed by simultaneous implant placement. all the procedures will be computer-guided with assistance of artificial intelligence

study group II

Free-hand sinus lift with autologous dentin block graft +free-hand immediate implant placement PROCEDURE

The sinus will be lifted and augmented by autologous block dentin graft followed by simultaneous free-hand implant placement

study group III

AI-assisted/computer-guided sinus lift with autologous dentin block graft +computer-guided immediate implant placement. PROCEDURE

The sinus will be lifted and augmented by autologous block dentin graft followed by simultaneous implant placement. all the procedures will be computer-guided with assistance of artificial intelligence

study group IV

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients requiring sinus augmentation with insufficient bone height (4-7 mm).
• Indicated for single or multiple implant placements.
• No systemic contraindications for implant surgery.

You may not qualify if:

• Severe sinus pathology (e.g., chronic sinusitis).
• History of radiation therapy in the maxillofacial region.
• Smokers
• Presence of acute (active) periapical infection.
• Large chronic periapical lesion.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of periodontology

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 20, 2025
• Study Start: March 21, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 10, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

EG (1)