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

Oral Soft Tissue Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513368
• Other study ID #: PHSIR
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2015
• Last updated: July 29, 2015
• Start date: January 2011
• Est. completion date: March 2014

Study information

• Verified date: July 2015
• Source: University of Firenze and Siena, Napoli, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• one missing tooth in the anterior maxilla

• facial keratinized mucosa thickness of at least 2mm

Exclusion Criteria:

• heavy smokers

• systemic diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oral Soft Tissue Conditions

Intervention

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

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

Locations

Country	Name	City	State
Italy	Siena University, Department of Periodontology, Policlinico Le Scotte Siena.	Siena
Italy	Tuscan School of Dentistry	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Firenze and Siena, Napoli, Italy

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No