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 | Completed Phase 2

• 1 other identifier: OMPDR042113
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stock abutments; Customized abutments; CAD/CAM technology; Class II extraction sockets

Outcome Measures

Primary Outcomes (2)

• Crestal Bone Thickness

  This outcome assesses the thickness of the crestal bone around the implant. It is critical for maintaining implant stability and aesthetics, with changes potentially indicating either success in osseointegration or issues such as bone resorption.

  Assessments were made at three points, baseline, after six months and twelve months post-implantation.

• Peri-implant Mucosal Level Changes

  This outcome measures the changes in the peri-implant mucosal levels around the implant site, particularly looking for recession or improvement in the gum tissue adjacent to the implant.

  Assessments were made at three points, baseline, after six months and twelve months post-implantation.

Study Arms (2)

Stock Abutment Group

ACTIVE COMPARATOR

This group consists of 24 participants who will receive two-piece dental implants with stock abutments. This arm serves as a control group to assess the standard outcomes associated with conventional abutments used in immediate implant scenarios in the esthetic zone.

Device: Stock Abutment Implant

Customized Titanium Milled Abutment Group

EXPERIMENTAL

This group also includes 24 participants and is considered the experimental group. These participants will receive two-piece dental implants equipped with customized cad cam titanium milled abutments. This arm is designed to evaluate the benefits of using customized abutments in terms of better soft and hard tissue integration and aesthetic outcomes compared to the standard stock abutment.

Device: Customized CAD CAM Titanium Milled Abutment Implant

Interventions

Stock Abutment Implant DEVICE

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.

Stock Abutment Group

Customized CAD CAM Titanium Milled Abutment Implant DEVICE

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.

Customized Titanium Milled Abutment Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults (20 -50)
• Patients will be included if they have one or more of hopeless teeth without signs of acute infection in the maxillary anterior region.
• Remaining roots or non-restorable teeth with sufficient bone apically and palatably to allow proper implant positioning with sufficient primary stability.
• Optimal compliance as evidenced by no missed treatment appointments and a positive attitude towards oral hygiene.
• Medically-free

You may not qualify if:

• Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
• Smokers, diabetics, pregnant or lactating women.
• \. History of chemotherapy, radiotherapy in head and/or neck region. 5. Bisphosphonate therapy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University.

Tanta, Elgharbia, 11000, Egypt

Location

Related Publications (1)

• Robaian A, Hamed MM, Ahmed Y, Hassanein FEA. Comparative Evaluation of Customized CAD/CAM vs. Stock Titanium Abutments for Immediate Implant Placement in Class II Extraction Sockets: A Randomized Controlled Trial. Dent J (Basel). 2025 Aug 15;13(8):371. doi: 10.3390/dj13080371.

  PMID: 40863074 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 24, 2025
• Study Start: January 22, 2024
• Primary Completion: September 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

EG (1)