The "One-piece" Autologous Tuberosity Graft

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Procedure: Socket preservation

• Registration Number: NCT04356001
• Lead Sponsor: Saint-Joseph University

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 Timeline

• Study Start: 2019-01-19
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-22
• Study First Submitted: 2020-03-06
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-17
• Last Update Submitted: 2020-04-17
• Study First Posted: 2020-04-21
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Socket preservation group	Socket preservation	Extraction sockets filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine.

Primary Outcome Measures

Name	Time	Method
Change of volume of the ridge from baseline to 4 months post-op	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	4 months	Linear Vertical variation of the ridge, measured on superimposed images of CBCT.
Change of Horizontal dimension of the ridge from baseline to 4 months post-op	4 months	Linear Horizontal variation of the ridge at 3 different levels, measured on superimposed images of CBCT.
Change in Soft tissue from baseline to 4 months post-op	4 months	Variation of the thickness of the buccal keratinized mucosa at 2 different levels, measured on superimposed images of CBCT.

Secondary Outcome Measures

Name	Time	Method
Change in buccal Soft tissue from baseline to 4 months post-op (clinical measurements)	4 months	Thickness of the keratinized mucosa on the buccal site, measured with a gauge caliper.
Change in crestal Soft tissue from baseline to 4 months post-op (clinical measurements)	4 months	Thickness of the keratinized mucosa on the crestal site, measured with a gauge caliper.
Change in Hard tissue from baseline to 4 months post-op (clinical measurements)	4 months	Horizontal dimension of the ridge (bucco-lingual) measured with a periodontal probe

Trial Locations

Locations (1)

Saint-Joseph university; 🇱🇧 Beirut, Lebanon