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

Sponsor
University of Firenze and Siena, Napoli, Italy (Other)
Overall Status
Completed
CT.gov ID
NCT02513368
Collaborator
(none)
32
2
2
37.9
16
0.4

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Device: augmentation procedure with Bio-Oss® and Bio-Gide®
  • Procedure: augmentation procedure with connective tissue graft
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Peri Implant Soft Tissue Healing in Single Implant Restoration Using the Guided Bone Regeneration Technique Ore a Connective Tissue Graft
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bio-Oss®, Bio-Gide®

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

Device: augmentation procedure with Bio-Oss® and Bio-Gide®
soft tissue management using GBR procedure

Active Comparator: connective tissue graft

augmentation procedure with connective tissue graft

Procedure: augmentation procedure with connective tissue graft
soft tissue management using the bilaminar technique

Outcome Measures

Primary Outcome Measures

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

  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 [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 [one month and one year after the placement of the definitive crowns]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Siena University, Department of Periodontology, Policlinico Le Scotte Siena. Siena Italy 53100
2 Tuscan School of Dentistry Siena Italy 53100

Sponsors and Collaborators

  • University of Firenze and Siena, Napoli, Italy

Investigators

  • Principal Investigator: massimo de sanctis, dentist, school of dentale medicine , university of siena

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
nicola baldini, oral surgeon, University of Firenze and Siena, Napoli, Italy
ClinicalTrials.gov Identifier:
NCT02513368
Other Study ID Numbers:
  • PHSIR
First Posted:
Jul 31, 2015
Last Update Posted:
Jul 31, 2015
Last Verified:
Jul 1, 2015
Keywords provided by nicola baldini, oral surgeon, University of Firenze and Siena, Napoli, Italy

Study Results

No Results Posted as of Jul 31, 2015