The "One-piece" Autologous Tuberosity Graft

Saint-Joseph University10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Socket preservationPROCEDURE

'One-Piece' autologous tuberosity graft combining hard and soft tissue, harvested from the maxillary tuberosity, placed in extraction sockets.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Saint-Joseph university

Beirut, Lebanon

Outcomes

Primary Outcomes

Change of volume of the ridge from baseline to 4 months post-op

Volumetric variation of the ridge, measured on superimposed images of CBCT.

Time frame: 4 months

Change of Vertical dimension of the ridge from baseline to 4 months post-op

Linear Vertical variation of the ridge, measured on superimposed images of CBCT.

Time frame: 4 months

Change of Horizontal dimension of the ridge from baseline to 4 months post-op

Linear Horizontal variation of the ridge at 3 different levels, measured on superimposed images of CBCT.

Time frame: 4 months

Change in Soft tissue from baseline to 4 months post-op

Variation of the thickness of the buccal keratinized mucosa at 2 different levels, measured on superimposed images of CBCT.

Time frame: 4 months

Secondary Outcomes

Change in buccal Soft tissue from baseline to 4 months post-op (clinical measurements)

Thickness of the keratinized mucosa on the buccal site, measured with a gauge caliper.

Time frame: 4 months

Change in crestal Soft tissue from baseline to 4 months post-op (clinical measurements)

Thickness of the keratinized mucosa on the crestal site, measured with a gauge caliper.

Time frame: 4 months

Change in Hard tissue from baseline to 4 months post-op (clinical measurements)

Horizontal dimension of the ridge (bucco-lingual) measured with a periodontal probe

Time frame: 4 months

Data from ClinicalTrials.gov

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