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

July 29, 2015 updated by: nicola baldini, University of Firenze and Siena, Napoli, Italy

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Siena, Italy, 53100
        • Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
      • Siena, Italy, 53100
        • Tuscan School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • heavy smokers
  • systemic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in the clinical characteristics of the peri implant mucosa
Time Frame: 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
one month and one year after the placement of the definitive crowns

Secondary Outcome Measures

Outcome Measure
Time 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 probe
Time Frame: one month and one year after the placement of the definitive crowns
one 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 probe
Time Frame: one month and one year after the placement of the definitive crowns
one month and one year after the placement of the definitive crowns

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Firenze and Siena, Napoli, Italy

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 3, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 29, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PHSIR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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