The "One-piece" Autologous Tuberosity Graft

The "One-piece" Autologous Tuberosity Graft : a Novel Concept in Ridge Preservation

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: Socket preservation

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 1104 2020
    • Saint-Joseph University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Socket preservation group; Extraction sockets filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine.	Procedure: Socket preservation; 'One-Piece' autologous tuberosity graft combining hard and soft tissue, harvested from the maxillary tuberosity, placed in extraction sockets.; Other Names: autologous tuberosity graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of volume of the ridge from baseline to 4 months post-op	Volumetric variation of the ridge, measured on superimposed images of CBCT.	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.	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.	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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	4 months

Collaborators and Investigators

• Sponsor: Saint-Joseph University

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2019
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 22, 2019

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: autologous; extraction; socket preservation; maxillary tuberosity; hard and soft tissue graft
• Other Study ID Numbers: USJ -2018-65

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No