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Immediate ImplantPhase 2NCT06241196

Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft

A Phase 2 study testing implant, Vestibular Socket Therapy and Alloderm in people with Immediate Implant, run by Tanta University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Immediate Implant
What is being tested?
implant, Vestibular Socket Therapy and Alloderm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteEgypt
Study dates
1 Jul 2022to 1 Apr 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • TantaU

    Tanta, Gharbia Governorate

Other trials in Egypt

About this study

Official title: Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft in Immediate Implants of Aesthetic Zone

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.

Read the detailed description

Twenty surgical sites will be divided into two groups; each of which has 10 surgical sites. Grouping will be done randomly sequentially numbered, opaque, sealed envelopes (SNOSE)

The groups will be treated as follow:

  • Group I: Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.
  • Group II: Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft Each group will be subjected to intraoral scanning 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.

The changes in gingival phenotype could be assessed at 6 months and 12 months intervals by superimposition of DICOM files on CBCT software Each group will be subjected to Cone Beam Computed Tomography (CBCT) at baseline, 6 months and 12months to asses both thickness and height of labial (facial) plate of bone and implant survival.

Being tested
implant, Vestibular Socket Therapy, Alloderm, Xenogenic bone membrane shield, Connective tissue graft
Keywords
vestibular socket therapy, dental implant, soft tissue graft

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • implantDevice

    Also called biohorizons implant, the pro,platform switching design,USA

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

  • Vestibular Socket TherapyProcedure or surgery

    Also called VST

    tunnel incision will be made in labial vestibule

  • AllodermDrug

    Also called AlloDerm SELECT™ RTM,biohorizons

    allogenic soft tissue substitute

  • Xenogenic bone membrane shieldDrug

    Also called Osteobiol ,flexible xenograft cortical sheet from Technoss,USA

    xenogenic bone membrane

  • Connective tissue graftProcedure or surgery

    Also called CTG

    soft tissue harvesting from palate

Study groups in NCT06241196
Study groupRoleWhat they receive
Group IActive comparatorTen sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.
Receives: Device: implant; Procedure: Vestibular Socket Therapy; Drug: Alloderm; Drug: Xenogenic bone membrane shield
Group IIExperimentalTen sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft.
Receives: Device: implant; Procedure: Vestibular Socket Therapy; Drug: Xenogenic bone membrane shield; Procedure: Connective tissue graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes in peri-implant mucosal level

    level of peri-implant mucosa

    Measured: baseline, 6, 12 months

  2. changes in gingival phenotype

    thickness of peri-implant mucosa

    Measured: baseline, 6, 12 months

Secondary outcomes (3)

  1. thickness of labial (facial) plate of bone

    three area measures of facial bone

    Measured: baseline, 6, 12 months

  2. implant survival

    implant stability, health, mobility and function

    Measured: baseline, 6, 12 months

  3. height of labial (facial) plate of bone

    Apico-coronal height of labial bone

    Measured: baseline, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2024
  2. Study start1 Jul 2022
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06241196
Sponsor's protocol ID
Implant_22
Status last verified
Jan 2024
First submitted
19 Jun 2023
Last updated
5 Feb 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Ellithy AA, El-Tonsy MM, Ghouraba SF, El-Fahl BN, Elaskary A, Elfana A. Immediate implant placement in compromised extraction sockets using vestibular socket therapy with acellular dermal matrix versus connective tissue grafts in the esthetic zone: a randomized controlled clinical trial. Clin Oral Investig. 2024 Nov 28;28(12):664. doi: 10.1007/s00784-024-06065-8.

    PubMed 39604639

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing implant, Vestibular Socket Therapy and Alloderm in people with Immediate Implant, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes in peri-implant mucosal level (time frame: baseline, 6, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06241196, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.

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