Clinical trial NCT05638958: Immediate Implants With Customized Abutments
Official title: Effect of Peri-implant Gap Grafting and Immediate Provisionalization With Customized Healing Abutments on the Stability of Peri-implant Soft Tissues - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous Alveolar Ridge Atrophy
Keywords: immediate implants
immediate provvisional
soft tissue recession
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Implant success
timeFrame: 1 year of follow up
measure: Peri-implant marginal bone level- Radiographic Measurements
timeFrame: 1 year of follow up
measure: Peri-implant marginal bone level- Radiographic Measurements
timeFrame: 2 years of follow up
measure: Peri-implant marginal bone level- Radiographic Measurements
timeFrame: 3 years of follow up
measure: Implant success
timeFrame: 2 years of follow up
measure: Implant success
timeFrame: 3 years of follow up
Secondary outcomes:
measure: Changes in mid-facial mucosal recession
timeFrame: 1 year of follow up
measure: Changes in mid-facial mucosal recession
timeFrame: 2 years of follow up
measure: Changes in mid-facial mucosal recession
timeFrame: 3 years of follow up
measure: Changes in papilla height
timeFrame: 1 year of follow up
measure: Changes in papilla height
timeFrame: 2 years of follow up
measure: Changes in papilla height
timeFrame: 3 years of follow up
measure: Changes in soft tissue ridge width - Volumetric measurements
timeFrame: 1 year of follow up
measure: Changes in soft tissue ridge width - Volumetric measurements
timeFrame: 2 years of follow up
measure: Changes in soft tissue ridge width - Volumetric measurements
timeFrame: 3 years of follow up
measure: Aesthetic evaluation (PES)
timeFrame: 1 year of follow up
measure: Aesthetic evaluation (PES)
timeFrame: 2 years of follow up
measure: Aesthetic evaluation (PES)
timeFrame: 3 years of follow up
measure: Implant stability (ISQ)
timeFrame: 90 days after insertion of the definitive crown
measure: Implant stability (ISQ)
timeFrame: 160 days after insertion of the definitive crown
measure: Implant stability (ISQ)
timeFrame: 1 year of followup
measure: Implant stability (ISQ)
timeFrame: 2 years of follow up
measure: Implant stability (ISQ)
timeFrame: 3 years of follow up
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: HUG
Study officials:
References: