The "One-piece" Autologous Tuberosity Graft : a Novel Concept in Ridge Preservation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change of Horizontal dimension of the ridge from baseline to 4 months post-op
Study Overview
Brief Summary
A prospective study investigating clinically and radiologically the effectiveness of the use of a combined hard and soft tissue graft retrieved from the maxillary tuberosity and designed for alveolar ridge preservation following tooth extraction.
Detailed Description
Patients scheduled for a single mono-rooted tooth extraction are included in the study. After atraumatic extraction, sockets are filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine. CBCTs are performed before the extraction and 4 months after ridge preservation, to analyze the vertical and horizontal alterations of the ridge, using 'ITK-Snap' software.
Clinical measurements of both soft and hard tissues are also assessed during the extraction and implant placement.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy patient
- •Patient with at least one single-rooted tooth to be extracted and be replaced with an implant
- •No signs of acute infection : edema, suppuration, abscess, spontaneous bleeding
- •Non-smoker or Light Smoker < 10 cigarettes/day
Exclusion Criteria
- •Pregnant or lactating females
- •Non-controlled periodontal disease
- •Medical conditions that contraindicate implant surgery
- •Metabolic bone disorders such as osteoporosis,..
- •Severe psychiatric conditions
- •Heavy smoker > 10 cigarettes/day
Arms & Interventions
Socket preservation group
Extraction sockets filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine.
Intervention: Socket preservation (Procedure)
Outcomes
Primary Outcomes
Change of Horizontal dimension of the ridge from baseline to 4 months post-op
Time Frame: 4 months
Linear Horizontal variation of the ridge at 3 different levels, measured on superimposed images of CBCT.
Change of volume of the ridge from baseline to 4 months post-op
Time Frame: 4 months
Volumetric variation of the ridge, measured on superimposed images of CBCT.
Change of Vertical dimension of the ridge from baseline to 4 months post-op
Time Frame: 4 months
Linear Vertical variation of the ridge, measured on superimposed images of CBCT.
Change in Soft tissue from baseline to 4 months post-op
Time Frame: 4 months
Variation of the thickness of the buccal keratinized mucosa at 2 different levels, measured on superimposed images of CBCT.
Secondary Outcomes
- Change in crestal Soft tissue from baseline to 4 months post-op (clinical measurements)(4 months)
- Change in buccal Soft tissue from baseline to 4 months post-op (clinical measurements)(4 months)
- Change in Hard tissue from baseline to 4 months post-op (clinical measurements)(4 months)