NCT06241196

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

June 19, 2023

Last Update Submit

January 26, 2024

Conditions

Immediate Implant

Keywords

vestibular socket therapydental implantsoft tissue graft

Outcome Measures

Primary Outcomes (2)

  • changes in peri-implant mucosal level

    level of peri-implant mucosa

    baseline, 6, 12 months

  • changes in gingival phenotype

    thickness of peri-implant mucosa

    baseline, 6, 12 months

Secondary Outcomes (3)

  • thickness of labial (facial) plate of bone

    baseline, 6, 12 months

  • implant survival

    baseline, 6, 12 months

  • height of labial (facial) plate of bone

    baseline, 6, 12 months

Study Arms (2)

Group I

ACTIVE COMPARATOR

Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.

Device: implantProcedure: Vestibular Socket TherapyDrug: AllodermDrug: Xenogenic bone membrane shield

Group II

EXPERIMENTAL

Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft.

Device: implantProcedure: Vestibular Socket TherapyDrug: Xenogenic bone membrane shieldProcedure: Connective tissue graft

Interventions

implantDEVICE

Implant will be placed through the surgical guide in the extraction socket

Also known as: biohorizons implant, the pro,platform switching design,USA
Group IGroup II
Vestibular Socket TherapyPROCEDURE

tunnel incision will be made in labial vestibule

Also known as: VST
Group IGroup II
AllodermDRUG

allogenic soft tissue substitute

Also known as: AlloDerm SELECTâ„¢ RTM,biohorizons
Group I
Xenogenic bone membrane shieldDRUG

xenogenic bone membrane

Also known as: Osteobiol ,flexible xenograft cortical sheet from Technoss,USA
Group IGroup II
Connective tissue graftPROCEDURE

soft tissue harvesting from palate

Also known as: CTG
Group II

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults (20-50) years old.
  • Class II socket according to Elian et al, (7)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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TantaU

Tanta, Gharbia Governorate, Egypt

Location

MeSH Terms

Interventions

Mutagenesis, InsertionalAlloderm

Intervention Hierarchy (Ancestors)

Protein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Study Officials

  • amr anwar mohammed ellithy yousef, Msc

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

June 19, 2023

First Posted

February 5, 2024

Study Start

July 1, 2022

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

February 5, 2024

Record last verified: 2024-01

Locations

EG(1)