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Completed

NCT Number: NCT02513368

Peri Implant Soft Tissue Healing in Single Implant Restoration Using Two Different Techniques

The aim of the present study was to propose the employment of Bio-Oss® and Bio-Gide® at implant site in order to evaluate if the increased bucco-lingual bone thickness could enhance the stability of peri implant soft tissue, when compared to the grafting technique ( bilaminar technique), performed in association with implant placement .

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Siena University, Department of Periodontology, Policlinico Le Scotte Siena., Siena, Italy

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About this study

With respect to the soft tissue management many surgical approaches have been described in order to increase soft tissue volume and keratinized tissue height at implant site: roll flaps, connective tissue graft , epithelial connective tissue graft. In recent years, soft tissue substitutes , such as acellular dermal matrix or collagen matrix have been proposed to increase the dimensions of peri implant soft tissues; however, further studies have demonstrated that the allograft materials were less effective and less predictable than autogenous soft tissue grafts, in terms of increasing attached keratinized tissue , due to the considerable shrinkage and inconsistent quality of the attached tissue gained ; consequently soft tissue graft from the palate are currently considered the gold standard for augmenting peri implant soft. Some clinical studies proposed the association of contour augmentation by guided bone regeneration (GBR) with implant placement. The aim of these procedures is to restore the missing volume and to establish a facial bone wall of sufficient height and thickness to serve as a support for peri implant soft tissues; in these terms, GBR could be considered important to increase the stability of peri implant soft tissue , preventing the marginal soft tissue shrinkage and the following exposition of implant . This could be a valid approach to stabilize coronal peri implant soft tissue and at the same time less traumatic than grafting procedures.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • one missing tooth in the anterior maxilla
  • facial keratinized mucosa thickness of at least 2mm

Exclusion criteria

  • heavy smokers
  • systemic diseases

Treatment and study plan

augmentation procedure with Bio-Oss® and Bio-Gide®

Device

soft tissue management using GBR procedure

augmentation procedure with connective tissue graft

Procedure

soft tissue management using the bilaminar technique

Primary outcomes

  1. change from baseline in the clinical characteristics of the peri implant mucosa

    Time frame: one month and one year after the placement of the definitive crowns

    Buccal mucosa thickness was assessed with a calibrated endodontic file, 2 mm apical to the bone crest

Secondary outcomes

  1. Change from baseline in probing pocket depth recorded at both mesial and distal tooth , adjacent to the implant site, by means of a periodontal probe

    Time frame: one month and one year after the placement of the definitive crowns

  2. change from baseline in height of keratinised tissue recorded at both mesial and distal tooth , adjacent to the implant site , by means of a periodontal probe

    Time frame: one month and one year after the placement of the definitive crowns

Sponsors and collaborators

Lead sponsor

University of Firenze and Siena, Napoli, Italy

Other

Registry information

Official study title

Peri Implant Soft Tissue Healing in Single Implant Restoration Using the Guided Bone Regeneration Technique Ore a Connective Tissue Graft

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jul 31, 2015
Registry last updated
Jul 31, 2015

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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