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

NCT ID: NCT04980313

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-27

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Xenograft Model

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Xenogenic collagen matrix

Volumetrically stable xenogenic collagen matrix

Group Type EXPERIMENTAL

Xenogenic collagen matrix

Intervention Type DEVICE

Use of xenogenic collagen matrix for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.

Autogenous connective tissue graft

Autogenous connective tissue graft obtained from the tuberosity area

Group Type ACTIVE_COMPARATOR

Autogenous connective tissue graft

Intervention Type DEVICE

Use of connective tissue graft for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.

Interventions

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Xenogenic collagen matrix

Use of xenogenic collagen matrix for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.

Intervention Type DEVICE

Autogenous connective tissue graft

Use of connective tissue graft for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Geistlich Pharma AG

INDUSTRY

Sponsor Role collaborator

Universitat Internacional de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Octavi Ortiz Puigpelat

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinica Dental Ortiz-Puigpelat

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Octavi Ortiz-Puigpelat, DDS, PhD

Role: CONTACT

+34629831138

Facility Contacts

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Octavi Ortiz-Puigpelat

Role: primary

+34629831138

Other Identifiers

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CIR-ELC-2021-01

Identifier Type: -

Identifier Source: org_study_id

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