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Using Fascia Lata Membrane Versus Connective Tissue Graft in Immediate Implants

Sponsor
Hams Hamed Abdelrahman (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05194826
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
9.9
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Test
  • Procedure: Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vestibular Socket Therapy Using Fascia Lata Membrane Versus Connective Tissue Graft in Immediate Implants of Aesthetic Zone
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Mar 30, 2022
Anticipated Study Completion Date :
Mar 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fascia lata membrane

Procedure: Test
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
Active Comparator: Connective tissue graft both with xenogenic lamina membrane

Procedure: Control
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

Outcome Measures

Primary Outcome Measures

  1. Changes in peri-implant mucosal level [at baseline, 6 months and 12 months]

    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.

  2. Changes in gingival phenotype [at baseline, 6 months and 12 months]

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

  3. Chaneg in height of labial (facial) plate of bone [at baseline, 6 months and 12 months]

    Cone beam computed tomography (CBCT)

  4. Chaneg in thickness of labial (facial) plate of bone [at baseline, 6 months and 12 months]

    Cone beam computed tomography (CBCT)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta University Tanta Egypt

Sponsors and Collaborators

  • Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
ClinicalTrials.gov Identifier:
NCT05194826
Other Study ID Numbers:
  • VST_21_22
First Posted:
Jan 18, 2022
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 18, 2022