Immediate Implants With Customized Abutments

NCT05638958 | Unknown

• 1 other identifier: AB0005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Alveolar Ridge Atrophy

Keywords

immediate implants; immediate provvisional; soft tissue recession

Outcome Measures

Primary Outcomes (6)

• Implant success

  Evaluated according to the criteria of Albrektsson et al. (1986): * the implant is immobile when tested clinically * Radiography does not demonstrate evidence of peri-implant radiolucency * Bone loss that is less than 0.2 mm annually after the implant's first year of service * No pain, discomfort or infection

  1 year of follow up

• Peri-implant marginal bone level- Radiographic Measurements

  Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment.

  1 year of follow up

• Peri-implant marginal bone level- Radiographic Measurements

  Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment.

  2 years of follow up

• Peri-implant marginal bone level- Radiographic Measurements

  Peri-implant bone level will be assessed based on individual peri-apical x-rays performed at baseline, after implant placement, at the time of final impression at 90 days and after insertion of the definitive crown after 160 days using an individualized impression tray with resin imprints and at 1, 2, 3 years of follow up. The radiographic measurements will be performed by an independent evaluator, who will be unware of the assigned treatment.

  3 years of follow up

• Implant success

  Evaluated according to the criteria of Albrektsson et al. (1986): * the implant is immobile when tested clinically * Radiography does not demonstrate evidence of peri-implant radiolucency * Bone loss that is less than 0.2 mm annually after the implant's first year of service * No pain, discomfort or infection

  2 years of follow up

• Implant success

  Evaluated according to the criteria of Albrektsson et al. (1986): * the implant is immobile when tested clinically * Radiography does not demonstrate evidence of peri-implant radiolucency * Bone loss that is less than 0.2 mm annually after the implant's first year of service * No pain, discomfort or infection

  3 years of follow up

Secondary Outcomes (17)

• Changes in mid-facial mucosal recession

  1 year of follow up

• Changes in mid-facial mucosal recession

  2 years of follow up

• Changes in mid-facial mucosal recession

  3 years of follow up

• Changes in papilla height

  1 year of follow up

• Changes in papilla height

  2 years of follow up

Study Arms (2)

Test group

EXPERIMENTAL

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.

Device: Immediate post-extractive Implant placement

Control group

ACTIVE COMPARATOR

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

Device: Immediate post-extractive Implant placement

Interventions

Immediate post-extractive Implant placement 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; Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

HUG

Geneva, 1205, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants ant the biostatician will be blinded on the assignment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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. 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.

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 6, 2022
• Study Start: March 10, 2018
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2023
• Last Updated: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)