The "One-piece" Autologous Tuberosity Graft

NCT ID: NCT04356001

Last Updated: 2020-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-19

Study Completion Date

2019-12-22

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Socket preservation group

Extraction sockets filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine.

Group Type EXPERIMENTAL

Socket preservation

Intervention Type PROCEDURE

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

Interventions

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Socket preservation

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

Intervention Type PROCEDURE

Other Intervention Names

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autologous tuberosity graft

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saint-Joseph University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Saint-Joseph university

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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USJ -2018-65

Identifier Type: -

Identifier Source: org_study_id

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