Clinical Outcomes of Immediate Implants With or Without a Volume-stable Collagen Matrix

University of Pisa

Status: Enrolling

Conditions: Edentulous Alveolar Ridge

Treatments: Device: Volume-stable collagen matrix Geistlich Fibro-Gide®

Study type: Interventional

Funder types: Other

Identifiers

NCT05081284

19228

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. 2008.
• Patients with known allergy, sensitivity or intolerance to collagen
• Patients who are pregnant or who are breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Control group

No Intervention group

Description:

Immediate implant insertion in fresh-extraction site, will be performed. Peri-implant bone defect will be grafted with a deproteinized bovine bone mineral with 10% collagen and covered with a collagen matrix. After the surgical procedures, each implant will receive a healing abutment until prosthetic restorative procedures.

Test Group

Experimental group

Description:

Immediate implant insertion in fresh-extraction site, will be performed. Peri-implant bone defect will be grafted with a deproteinized bovine bone mineral with 10% collagen and covered with a collagen matrix, and then a volume-stable collagen matrix will be buccally inserted with a split-thickness flap preparation. Subsequently, the collagen matrix graft will be stabilized with a horizontal mattress suture to the buccal flap. After the surgical procedures, each implant will receive healing abutment connection until the prosthetic restorative procedures

Treatment:

Device: Volume-stable collagen matrix Geistlich Fibro-Gide®