Immediate Implants With Customized Abutments

University Hospitals (UH)

Status: Active, not recruiting

Conditions: Edentulous Alveolar Ridge Atrophy

Treatments: Device: Immediate post-extractive Implant placement

Study type: Interventional

Funder types: Other

Identifiers

NCT05638958

AB0005

Details and patient eligibility

About

Tooth extraction is followed by marked alterations of the tissue volume. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue.

Teeth scheduled for extraction will be used to study the effect of a customized healing abutment.

The following groups will be randomly assigned:

Control: A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft.

Test: A customized PEEK abutment mimicking the subgingival emergence of the extracted tooth will be screw retained on top of the implant to seal the extraction site.

Full description

Tooth extraction is followed by marked alterations of the tissue volume. Incorporation of biomaterials into a fresh extraction socket can significantly reduce alveolar resorption but is not able to diminish the biologic process of the buccal bone plate. The resorption process of at least the surrounding mucosa can be altered by using immediate implant placement and additional features such as immediate provisional crown, platform switching and grafting the gap between implant and buccal bone plate. The support of the gingival margin with a provisional crown led to an increase of buccal gingival tissue. Platform switching seems to be a viable option to reduce interproximal bone level alterations and to limit the buccal soft tissue recession. Furthermore, augmenting the defect between the implant and the buccal bone plate has been proven to reduce the resorption process and lead to less shrinkage.

The primary objective is:

• The implant success

The Secondary objectives are:

• The Changes in mid-facial mucosal recession
• The changes in papilla height
• The changes in soft tissue ridge width
• The aesthetic evaluation
• The implant stability

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:•

• The patient is ≥ 18 years old
• Extraction of single rooted tooth with healthy adjacent teeth (PD<5mm, no BOP)
• Patient must be able to understand the purpose of the study and to sign the consent form

Exclusion Criteria:

• Smoking status of more than 10 cigarettes/day
• History of uncontrolled metabolic disorders (e.g. diabetes mellitus)
• History of malignancy, radiotherapy, or chemotherapy
• Pregnant or breast feeding
• History of immunodeficiences
• existence of metabolic bone disease or disease affecting bone healing
• untreated or active periodontitis (BOP and PD>5mm)
• absence or defects of the buccal bone plate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Test group

Experimental group

Description:

A customized PEEK abutment mimicking the subgingival emergence of the extraction site will be screw-retained on the implant to seal the extraction site and to support healing of buccal soft tissues.

Treatment:

Device: Immediate post-extractive Implant placement

Control group

Active Comparator group

Description:

A commercially available healing abutment will be screwed on top of the implant and a collagen sponge will be used to protect the graft.

Treatment:

Device: Immediate post-extractive Implant placement