Connective Tissue Graft Versus a Porcine-derived Membrane (Mucoderm) After Immediate Placement

Vilniaus Implantologijos Centro (VIC) Klinika

Status: Active, not recruiting

Conditions: Immediate Implants

Treatments: Device: Dental implant placement, bone and soft tissue augmentation on buccal site

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT04737525

IIS1418

Details and patient eligibility

About

Esthetic outcome of immediate implant placement in fresh extraction sockets remains one of the biggest challenges in implant dentistry. Recently a method to preserve the peri-implant tissues was introduced using provisional restoration, allogenic bone and soft tissue thickening. However, the evidence that this immediate provisialisation with soft tissue grafting using different grafting materials results in constantly high Pink Esthetic scores, especially compared to the delayed loading approach is still lacking.

The aim of this clinical trial is to assess the esthetic outcome of immediate temporization of immediately placed and loaded tapered implants in fresh extraction sockets with bone and soft tissue augmentation, using either a connective tissue graft (CTG) or a porcine-derived membrane (Mucoderm) in maxillary anterior sites.

The secondary objectives are to investigate the influence of immediate loading on the success rate of tapered implants and crestal bone levels.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males and females of at least 18 years of age
2. 1 implant per patient
3. Subject must have voluntarily signed the informed consent before any study related action, are willing and able to attend scheduled follow-up visits, and agree that the pseudonymized data will be collected and analyzed
4. Anterior single teeth (canines and incisors) in both jaws
5. Class I extraction socket (intact buccal wall) or Class II (1/3 of buccal wall)
6. No recession of gingival contour of tooth to be extracted
7. No periodontal bone loss of neighboring anterior teeth
8. No implants in neighboring teeth
9. Atraumatic extraction of the tooth with intact socket walls remaining

Exclusion criteria

1. Deep bite (severe II class)
2. Heavy smokers (more than 10 cigarettes/day)
3. Systemic disease (diabetes, osteoporosis)
4. Primary stability after implant placement not achieved
5. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Test group

Experimental group

Description:

Immediate implant placement and temporization of tapered implants after tooth extraction with buccal augmentation using allogenic bone and porcine-derived membrane.

Treatment:

Device: Dental implant placement, bone and soft tissue augmentation on buccal site

Control group

Experimental group

Description:

Immediate implant placement and temporization of tapered implants after tooth extraction with buccal augmentation using allogenic bone and connective tissue grafting (CTG).

Treatment:

Device: Dental implant placement, bone and soft tissue augmentation on buccal site