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

NCT ID: NCT04737525

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2031-02-10

Brief Summary

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.

Conditions

Immediate Implants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test group

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

1. Atraumatic extraction

2. Palatinal positioning of tapered implant (BLX) 3.75mm diameter

3. 3-4 mm below vestibular gingival line or 1 mm below bone crest

4. Implant placement

5. Allogenic bone packing of the "jumping distance" and soft tissue grafting

6. Connective tissue graft (CTG) or porcine-derived membrane

7. Provisional restoration out of occlusion and mandibular movements

8. X-ray

Control group

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

1. Atraumatic extraction

2. Palatinal positioning of tapered implant (BLX) 3.75mm diameter

3. 3-4 mm below vestibular gingival line or 1 mm below bone crest

4. Implant placement

5. Allogenic bone packing of the "jumping distance" and soft tissue grafting

6. Connective tissue graft (CTG) or porcine-derived membrane

7. Provisional restoration out of occlusion and mandibular movements

8. X-ray

Interventions

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

1. Atraumatic extraction

2. Palatinal positioning of tapered implant (BLX) 3.75mm diameter

3. 3-4 mm below vestibular gingival line or 1 mm below bone crest

4. Implant placement

5. Allogenic bone packing of the "jumping distance" and soft tissue grafting

6. Connective tissue graft (CTG) or porcine-derived membrane

7. Provisional restoration out of occlusion and mandibular movements

8. X-ray

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Straumann Group

UNKNOWN

Sponsor Role: collaborator

Vilniaus Implantologijos Centro (VIC) Klinika

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

VIC clinic

Vilnius, , Lithuania

Countries

Lithuania

Other Identifiers

IIS1418

Identifier Type: -

Identifier Source: org_study_id