Peri Implant Soft Tissue Healing in Single Implant Restoration Using Two Different Techniques
1 other identifier
interventional
32
1 country
2
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2011
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 3, 2015
CompletedFirst Posted
Study publicly available on registry
July 31, 2015
CompletedJuly 31, 2015
July 1, 2015
2.9 years
July 3, 2015
July 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change from baseline in the clinical characteristics of the peri implant mucosa
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 Outcomes (2)
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
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
Study Arms (2)
Bio-Oss®, Bio-Gide®
EXPERIMENTALaugmentation procedure with Bio-Oss® and Bio-Gide®
connective tissue graft
ACTIVE COMPARATORaugmentation procedure with connective tissue graft
Interventions
soft tissue management using GBR procedure
soft tissue management using the bilaminar technique
Eligibility Criteria
You may qualify if:
- one missing tooth in the anterior maxilla
- facial keratinized mucosa thickness of at least 2mm
You may not qualify if:
- heavy smokers
- systemic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
Siena, Siena, 53100, Italy
Tuscan School of Dentistry
Siena, Siena, 53100, Italy
Related Publications (1)
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.
PMID: 23347346BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
massimo de sanctis, dentist
school of dentale medicine , university of siena
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- oral surgeon
Study Record Dates
First Submitted
July 3, 2015
First Posted
July 31, 2015
Study Start
January 1, 2011
Primary Completion
December 1, 2013
Study Completion
March 1, 2014
Last Updated
July 31, 2015
Record last verified: 2015-07