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

Not Applicable

Active, not recruiting

• Conditions: Immediate Implants
• Interventions: Device: Dental implant placement, bone and soft tissue augmentation on buccal site

• Registration Number: NCT04737525
• Lead Sponsor: Vilniaus Implantologijos Centro (VIC) Klinika

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2019-12-31
• Status Verified: 2021-01
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-31
• Last Update Submitted: 2021-01-31
• Study First Posted: 2021-02-04
• Last Update Posted: 2021-02-04
• Study Completion: 2031-02-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Dental implant placement, bone and soft tissue augmentation on buccal site	Immediate implant placement and temporization of tapered implants after tooth extraction with buccal augmentation using allogenic bone and connective tissue grafting (CTG).
Test group	Dental implant placement, bone and soft tissue augmentation on buccal site	Immediate implant placement and temporization of tapered implants after tooth extraction with buccal augmentation using allogenic bone and porcine-derived membrane.

Primary Outcome Measures

Name	Time	Method
Aesthetic evaluation	Change from baseline, 1 year, 5 and 10 years after prosthetic delivery	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.

Secondary Outcome Measures

Name	Time	Method
Recession of gingiva (REC)	Change from baseline, 1 year, 5 and 10 years after prosthetic delivery	Position of the gingival/mucosal margin - recorded with a periodontal probe from the incisal edge to the margin at the zenith.

Trial Locations

Locations (1)

VIC clinic; 🇱🇹 Vilnius, Lithuania