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Customized CAD/CAM Titanium-Milled Abutments Vs. Custom Abutments Over Immediate Implants in Class II Extraction Sockets in the Esthetic Zone: a Randomized Controlled Clinical Trial

NCT06791655 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-01-24

No results posted yet for this study

Summary

Background: Immediate implant placement in esthetic zones, particularly Class II and III extraction sockets, presents challenges related to soft and hard tissue changes post-extraction. Customized abutments may offer advantages over stock abutments in managing these changes and improving clinical outcomes.

Objective: This study aims to evaluate the comparative effectiveness of customized cad cam titanium milled abutments versus stock abutments on dental implants in Class II extraction sockets in terms of soft and hard tissue integration and aesthetic outcomes.

Methods: A randomized controlled clinical and radiographic trial will be conducted at the Oral Medicine, Periodontology, Oral Diagnosis, and Radiology Department of Tanta University. Forty-eight patients requiring immediate implants in the maxillary anterior region will be randomly assigned to receive either a stock abutment or a customized titanium milled abutment. All implants will be placed using a computer-assisted surgical guide and treated with a collagen plug. Clinical and radiographic evaluations will be performed at baseline, 6 months, and 12 months, utilizing intraoral scanning and cone beam computed tomography (CBCT) to assess peri-implant mucosal levels and crestal bone thickness.

Conditions

  • Implant Therapy
  • Class II Extraction Sockets

Interventions

DEVICE

Stock Abutment Implant

Participants in this intervention group receive a two-piece dental implant that utilizes a stock abutment. The stock abutment is a prefabricated component that connects the implant to the prosthetic suprastructure. This intervention aims to evaluate the standard outcomes of using stock abutments in the restoration of teeth in esthetic zones after immediate implant placement.

DEVICE

Customized CAD CAM Titanium Milled Abutment Implant

Participants in this intervention group are treated with a two-piece dental implant that includes a customized CAD CAM titanium milled abutment. These abutments are tailor-made using computer-aided design and manufacturing to fit the specific contours and needs of the patient's dental structure. This customized approach is hypothesized to offer superior integration with the soft and hard tissues, leading to better aesthetic outcomes and tissue health around the implant area.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2024-09-20
Completion
2024-12-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06791655 on ClinicalTrials.gov