Immediate Implants With Customized Abutments

NCT ID: NCT05638958

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-10
• Study Completion Date: 2023-03-10

Brief Summary

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.

Detailed 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

Conditions

Edentulous Alveolar Ridge Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test group

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.

Group Type: EXPERIMENTAL

Immediate post-extractive Implant placement

Intervention Type: DEVICE

Teeth scheduled for extraction will be used to study the effect of a customized healing abutment. All patients should receive prophylactic antibiotic therapy of 2g of amoxicillin (or clindamycin 600mg if allergic to penicillin) 1 hour before the surgery. Implant placed along the lingual/palatal bone plate and the implant platform should be placed at the level of the buccal bone plate. GUIDOR easy-graft CRYSTAL will be used to fill the defect between implant and buccal bone plate, subsequently, a standard healing abutment or a customized healing abutment will be screw-retained on the implants.

Control group

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

Group Type: ACTIVE_COMPARATOR

Immediate post-extractive Implant placement

Intervention Type: DEVICE

Teeth scheduled for extraction will be used to study the effect of a customized healing abutment. All patients should receive prophylactic antibiotic therapy of 2g of amoxicillin (or clindamycin 600mg if allergic to penicillin) 1 hour before the surgery. Implant placed along the lingual/palatal bone plate and the implant platform should be placed at the level of the buccal bone plate. GUIDOR easy-graft CRYSTAL will be used to fill the defect between implant and buccal bone plate, subsequently, a standard healing abutment or a customized healing abutment will be screw-retained on the implants.

Interventions

Immediate post-extractive Implant placement

Teeth scheduled for extraction will be used to study the effect of a customized healing abutment. All patients should receive prophylactic antibiotic therapy of 2g of amoxicillin (or clindamycin 600mg if allergic to penicillin) 1 hour before the surgery. Implant placed along the lingual/palatal bone plate and the implant platform should be placed at the level of the buccal bone plate. GUIDOR easy-graft CRYSTAL will be used to fill the defect between implant and buccal bone plate, subsequently, a standard healing abutment or a customized healing abutment will be screw-retained on the implants.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Alexandre Perez

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

HUG

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

AB0005

Identifier Type: -

Identifier Source: org_study_id