Effect of Xenogeneic Collagen Matrix on the Peri-implant Tissues of Immediate Implants.

Universitat Internacional de Catalunya

Status: Unknown

Conditions: Xenograft Model

Treatments: Device: Xenogenic collagen matrix; Device: Autogenous connective tissue graft

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04980313

CIR-ELC-2021-01

Details and patient eligibility

About

The present clinical trial will try to demonstrate the efficacy of stable xenogeneic collagen matrix in maintaining the vestibular coronal soft tissue volume and the stabilization of mid-buccal margin position in immediate post-extraccion sockets compared with the use of autogenous connective tissue grafts.

Enrollment: 52 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adequate oral hygiene (21).
2. Sufficient interocclusal space (≥6 mm) to place a provisional crown without occlusion.
3. Presence of adjacent teeth. Only one tooth gap.
4. Presence of soft tissue and cortical buccal bone of the tooth to be extracted according to the classification of Elian et al. 2007
5. Adequate bone quantity in the apical region of the tooth to be extracted (assessed on the CBCT).

Exclusion criteria

1. Patients with medical conditions that affect bone and soft tissue metabolism.
2. Uncontrolled endocrine disorders.
3. Alcohol and drug abuse.
4. Previous history of immunodeficiency syndromes.
5. Patients who smoke> 10 cigarettes a day.
6. Active periodontal disease.
7. Absence of a tooth adjacent to the tooth to be treated.
8. Oral lesions of the untreated mucosa.
9. Recent previous history (<6 months) of local radiotherapy or chemotherapy.
10. Bruxism or severe parafunctions.
11. Pregnant patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Xenogenic collagen matrix

Experimental group

Description:

Volumetrically stable xenogenic collagen matrix

Treatment:

Device: Xenogenic collagen matrix

Autogenous connective tissue graft

Active Comparator group

Description:

Autogenous connective tissue graft obtained from the tuberosity area

Treatment:

Device: Autogenous connective tissue graft