Skip to content

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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02513368
Enrollment
32
Registered
2015-07-31
Start date
2011-01-31
Completion date
2014-03-31
Last updated
2015-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Soft Tissue Conditions

Keywords

aesthetic, connective tissue graft, mucosa thickness

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.

Interventions

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

soft tissue management using GBR procedure

PROCEDUREaugmentation procedure with connective tissue graft

soft tissue management using the bilaminar technique

Sponsors

University of Firenze and Siena, Napoli, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* heavy smokers * systemic diseases

Design outcomes

Primary

MeasureTime frameDescription
change from baseline in the clinical characteristics of the peri implant mucosaone month and one year after the placement of the definitive crownsBuccal mucosa thickness was assessed with a calibrated endodontic file, 2 mm apical to the bone crest

Secondary

MeasureTime frame
Change from baseline in probing pocket depth recorded at both mesial and distal tooth , adjacent to the implant site, by means of a periodontal probeone month and one year after the placement of the definitive crowns
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 probeone month and one year after the placement of the definitive crowns

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026