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
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
-
-
-
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®
|
soft tissue management using GBR procedure
|
|
Active Comparator: connective tissue graft
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.
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.
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
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.