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

NCT04737525 | Active Not Recruiting

• 1 other identifier: IIS1418
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Soft tissue grafting

Outcome Measures

Primary Outcomes (1)

• Aesthetic evaluation

  Pink esthetic score (PES) according to Fürhauser et al. 2005 Seven variables will be evaluated: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14. For the PES assessment, frontal photographs will be taken using a digital camera with a flash strobe mounted on a tripod (Canon 350d, 3456×2304 pixel resolution). PES will be assessed at baseline (Final Prosthesis), 3- and 12-month visit.

  Change from baseline, 1 year, 5 and 10 years after prosthetic delivery

Secondary Outcomes (1)

• Recession of gingiva (REC)

  Change from baseline, 1 year, 5 and 10 years after prosthetic delivery

Study Arms (2)

Test group

EXPERIMENTAL

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

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

Control group

EXPERIMENTAL

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

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females of at least 18 years of age
• implant per patient
• 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
• Anterior single teeth (canines and incisors) in both jaws
• Class I extraction socket (intact buccal wall) or Class II (1/3 of buccal wall)
• No recession of gingival contour of tooth to be extracted
• No periodontal bone loss of neighboring anterior teeth
• No implants in neighboring teeth
• Atraumatic extraction of the tooth with intact socket walls remaining

You may not qualify if:

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

Sponsors & Collaborators

• Vilniaus Implantologijos Centro (VIC) Klinika: lead
• Straumann Group: collaborator

Study Sites (1)

VIC clinic

Vilnius, 10205, Lithuania

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 4, 2021
• Study Start: August 1, 2017
• Primary Completion: December 31, 2019
• Study Completion (Estimated): February 10, 2031
• Last Updated: February 4, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)