Using Fascia Lata Membrane Versus Connective Tissue Graft in Immediate Implants

NCT05194826 | Unknown

• 1 other identifier: VST_21_22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate and compare the Vestibular Socket Therapy (VST) technique using fascia lata membrane versus connective tissue graft both with xenogenic lamina membrane in immediate implants of anterior aesthetic zone.

Conditions

Connective Tissue Graft; Anterior Aesthetic Zone

Outcome Measures

Primary Outcomes (4)

• Changes in peri-implant mucosal level

  The changes in peri-implant mucosal level will be assessed by superimposition of scanning files of different intervals to monitor the changes in surface area calculated by software.

  at baseline, 6 months and 12 months

• Changes in gingival phenotype

  The changes in gingival phenotype could be assessed at 6 months and 12 months intervals by superimposition of DICOM files on CBCT software.

  at baseline, 6 months and 12 months

• Chaneg in height of labial (facial) plate of bone

  Cone beam computed tomography (CBCT)

  at baseline, 6 months and 12 months

• Chaneg in thickness of labial (facial) plate of bone

  Cone beam computed tomography (CBCT)

  at baseline, 6 months and 12 months

Study Arms (2)

Fascia lata membrane

EXPERIMENTAL

Procedure: Test

Connective tissue graft both with xenogenic lamina membrane

ACTIVE COMPARATOR

Procedure: Control

Interventions

Test PROCEDURE

immediate implant and VST with fascia lata membrane + xenogenic lamina membrane and particulate bone graft composed of autogenous cortical chips harvested from the surgical site

Fascia lata membrane

Control PROCEDURE

immediate implant and VST with connective tissue graft + xenogenic lamina membrane and particulate bone graft composed of autogenous cortical chips harvested from the surgical site

Connective tissue graft both with xenogenic lamina membrane

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Class II socket according to Elian et al, described as facial soft tissue is present but the buccal plate is partially missing following extraction of the tooth in the maxillary anterior region.
• Thin gingival phenotype.
• Bone quality ranges from D2-D3 as gained from preoperative cone-beam computed tomography.
• Presence of at least 3 mm of keratinized gingiva.
• Optimal compliance as evidenced by no missing treatment appointments and a positive attitude towards oral hygiene

You may not qualify if:

• Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
• Smokers, diabetics, pregnant or lactating women.
• History of chemotherapy, radiotherapy in head and/or neck region.
• Bisphosphonate therapy.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: June 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

EG (1)