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NCT Number: NCT04737525

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Immediate Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VIC clinic

Vilnius, 10205, Lithuania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females of at least 18 years of age
  • 1 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

Exclusion criteria

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

Treatment and study plan

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

Device
  • Atraumatic extraction
  • Palatinal positioning of tapered implant (BLX) 3.75mm diameter
  • 3-4 mm below vestibular gingival line or 1 mm below bone crest
  • Implant placement
  • Allogenic bone packing of the "jumping distance" and soft tissue grafting
  • Connective tissue graft (CTG) or porcine-derived membrane
  • Provisional restoration out of occlusion and mandibular movements
  • X-ray

Primary outcomes

  1. Aesthetic evaluation

    Time frame: 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 outcomes

  1. Recession of gingiva (REC)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vilniaus Implantologijos Centro (VIC) Klinika

Network

Collaborators

  • Straumann Group

Registry information

Official study title

The Influence of a Connective Tissue Graft Versus a Porcine-derived Membrane (Mucoderm) on the Aesthetic Outcome After Immediate Placement and Loading of a Tapered Dental Implant in the Anterior Maxilla. A Randomized Controlled Clinical Trial.

Important dates

Study start
2017
Primary completion
2019
Study completion
2031
First posted
Feb 4, 2021
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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