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

NCT ID: NCT02513368

Last Updated: 2015-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-03-31

Brief Summary

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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 .

Detailed Description

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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.

Conditions

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Oral Soft Tissue Conditions

Keywords

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aesthetic connective tissue graft mucosa thickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Bio-Oss®, Bio-Gide®

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

soft tissue management using GBR procedure

connective tissue graft

augmentation procedure with connective tissue graft

Group Type ACTIVE_COMPARATOR

augmentation procedure with connective tissue graft

Intervention Type PROCEDURE

soft tissue management using the bilaminar technique

Interventions

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

soft tissue management using GBR procedure

Intervention Type DEVICE

augmentation procedure with connective tissue graft

soft tissue management using the bilaminar technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* heavy smokers
* systemic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Firenze and Siena, Napoli, Italy

OTHER

Sponsor Role lead

Responsible Party

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nicola baldini

oral surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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massimo de sanctis, dentist

Role: PRINCIPAL_INVESTIGATOR

school of dentale medicine , university of siena

Locations

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

Siena, Siena, Italy

Site Status

Tuscan School of Dentistry

Siena, Siena, Italy

Site Status

Countries

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Italy

References

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Buser D, Chappuis V, Bornstein MM, Wittneben JG, Frei M, Belser UC. Long-term stability of contour augmentation with early implant placement following single tooth extraction in the esthetic zone: a prospective, cross-sectional study in 41 patients with a 5- to 9-year follow-up. J Periodontol. 2013 Nov;84(11):1517-27. doi: 10.1902/jop.2013.120635. Epub 2013 Jan 24.

Reference Type BACKGROUND
PMID: 23347346 (View on PubMed)

Other Identifiers

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PHSIR

Identifier Type: -

Identifier Source: org_study_id