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

University of Firenze and Siena, Napoli, Italy

Status and phase: Completed; Phase 2

Conditions: Oral Soft Tissue Conditions

Treatments: Procedure: augmentation procedure with connective tissue graft; Device: augmentation procedure with Bio-Oss® and Bio-Gide®

Study type: Interventional

Funder types: Other

Identifiers

NCT02513368

PHSIR

Details and patient eligibility

About

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 .

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• heavy smokers
• systemic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Bio-Oss®, Bio-Gide®

Experimental group

Description:

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

Treatment:

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

connective tissue graft

Active Comparator group

Description:

augmentation procedure with connective tissue graft

Treatment:

Procedure: augmentation procedure with connective tissue graft