Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix: a Randomized Controlled Clinical Trial

University of Pisa1 site in 1 country40 target enrollmentNovember 1, 2021

ConditionsEdentulous Alveolar Ridge

Overview

Phase: N/A
Intervention: Not specified
Conditions: Edentulous Alveolar Ridge
Sponsor: University of Pisa
Enrollment: 40
Locations: 1
Primary Endpoint: Soft Tissue Thickness (STT)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the soft tissue clinical results in patients that received, or not, a soft tissue augmentation around dental implant inserted immediately after the extraction.

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determinate eligibility for study entry. Patients who meet eligibility requirements will be randomized in this single blinded(investigator) study. Group (Test) will receive immediate implant after extraction and a soft tissue augmentation with a collagen matrix. Group (Control) will receive only immediate implant after extraction without soft tissue augmentation.

Registry

clinicaltrials.gov

Start Date

November 1, 2021

End Date

November 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Pisa

Responsible Party

Principal Investigator

Antonio Barone

Professor

University of Pisa

Eligibility Criteria

Inclusion Criteria

•Presence of a single failing tooth in the esthetic region (second premolar to contralateral second premolar), the adjacent teeth should be present and without any dental pathologies.

Exclusion Criteria

•Patients who are heavy smokers (more than 10 cigarettes/day);
•Patients who suffer from any systemic diseases that could negatively influence wound healing;
•Patients who received head and neck radiation treatment;
•Patients who have a full contraindication to implant surgery;
•Patients who have uncontrolled periodontal disease;
•Patients who show a full mouth plaque and bleeding score higher than 25%;
•Patients who have deficient extraction sockets according to the classification of Juodzbalys et al.
•Patients with known allergy, sensitivity or intolerance to collagen
•Patients who are pregnant or who are breastfeeding

Outcomes

Primary Outcomes

Soft Tissue Thickness (STT)

Time Frame: T2: 12 months after implant placement

Measured at 3 and 6 mm from the free gingival margin using a 15-endodontic file and a rubber disk. The file will advance perpendicularly through the soft tissue until the first point of bone contact. Thickness will be measured to the nearest 0.1 mm using a caliper. The rubber disk stop will be then placed in tight contact with the soft tissue surface and fixed with a drop of cyanocrylic adhesive. After file removal, the distance between file tip and the silicon stop will be measured using a digital caliper with 0.01 mm of accuracy. (Cairo et al. 2017; Bittner et al. 2020)