The "One-piece" Autologous Tuberosity Graft

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356001
• Other study ID #: USJ -2018-65
• Status: Completed
• Phase: N/A
• Start date: January 19, 2019
• Est. completion date: December 22, 2019

Study information

• Verified date: April 2020
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 22, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Lebanon	Saint-Joseph university	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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