Clinical trial NCT02513368: Peri Implant Soft Tissue Healing in Single Implant Restoration Using Two Different Techniques
Official title: Peri Implant Soft Tissue Healing in Single Implant Restoration Using the Guided Bone Regeneration Technique Ore a Connective Tissue Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Soft Tissue Conditions
Keywords: aesthetic
connective tissue graft
mucosa thickness
Lead sponsor: University of Firenze and Siena, Napoli, Italy
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* heavy smokers
* systemic diseases

Primary outcomes:
measure: change from baseline in the clinical characteristics of the peri implant mucosa
timeFrame: one month and one year after the placement of the definitive crowns
Secondary outcomes:
measure: 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
timeFrame: one month and one year after the placement of the definitive crowns
measure: 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
timeFrame: one month and one year after the placement of the definitive crowns
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
city: Siena
country: Italy
facility: Tuscan School of Dentistry
Study officials:
affiliation: school of dentale medicine , university of siena
name: massimo de sanctis, dentist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.