The "One-piece" Autologous Tuberosity Graft

NCT04356001 | Completed DMC

• 1 other identifier: USJ -2018-65
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

extraction; socket preservation; autologous; maxillary tuberosity; hard and soft tissue graft

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

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

  4 months

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

  4 months

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

  4 months

Study Arms (1)

Socket preservation group

EXPERIMENTAL

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

Procedure: Socket preservation

Interventions

Socket preservation PROCEDURE

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

Also known as: autologous tuberosity graft

Socket preservation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint-Joseph university

Beirut, 1104 2020, Lebanon

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: April 21, 2020
• Study Start: January 19, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 22, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

LE (1)