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Status unknownNCT04957654Updated Jul 12, 2021

Vestibular Socket Therapy in Immediate Implants With Grafting Materials

An interventional study of VST with collagen plug soaked in blood and VST with Allograft Demineralized bone matrix Grafton in Tooth Extraction, Dental Implant and Extarction Socket, sponsored by Mohamed Mofreh Hamada Hamed. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-07-12.

Sponsored by Mohamed Mofreh Hamada Hamed · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2021, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study summary

The current research aims at evaluating the outcomes of the vestibular socket therapy in immediate implants using collagen plug, demineralized freeze-dried bone allograft, and deproteinized bovine bone minerals at both radiographic and clinical levels

02

Conditions studied

  • Tooth Extraction
  • Dental Implant
  • Extarction Socket
03

In context

Lead sponsor

This is the only study on the registry with Mohamed Mofreh Hamada Hamed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients will be included if they have one or more hopeless teeth without signs of acute infection in the maxillary anterior region.
  • Remaining roots or non-restorable teeth with sufficient bone apically and palatably to allow proper implant positioning with sufficient primary stability.
  • Optimal compliance as evidenced by no missed treatment appointments and a positive attitude towards oral hygiene.
  • Medically free

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    VST with collagen plug soaked in blood

    Other: VST with collagen plug soaked in blood

  • Active comparator
    VST with Allograft Demineralized bone matrix Grafton

    Other: VST with Allograft Demineralized bone matrix Grafton

  • Active comparator
    VST with autogenous cortical chips and bovine deprotinzed particles

    Other: VST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles

Interventions

  • OtherVST with collagen plug soaked in blood

    -A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with collagen plug soaked in blood

  • OtherVST with Allograft Demineralized bone matrix Grafton

    -A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with Allograft Demineralized bone matrix Grafton

  • OtherVST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles

    -A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles

06

What researchers measure

Primary outcomes

  1. changes in facial plate thickness

    Each group will be subjected to: Cone beam computed tomography (CBCT) at baseline, 6 months, and 12months to assess the thickness of the labial (facial) plate of bone and implant survival

    Time frame: at baseline, 6 and 12 months

  2. changes in facial plate height

    Each group will be subjected to: Cone beam computed tomography (CBCT) at baseline, 6 months, and 12months to assess height of labial (facial) plate of bone and implant survival

    Time frame: at baseline, 6 and 12 months

Secondary outcomes

  1. changes in peri-implant mucosal level

    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.

    Time frame: at baseline, 3rd and 6th months

07

Study locations

1 of 1 sites recruiting
  • Faculty of Dentistry, Tanta University
    Tanta, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04957654
Lead sponsor
Mohamed Mofreh Hamada Hamed
Responsible party
Mohamed Mofreh Hamada Hamed (clinical researcher, Tanta University) — Sponsor-investigator
First posted
Jul 12, 2021
Start date
Mar 16, 2021
Primary completion
Apr 30, 2022 (estimated)
Completion
Jul 1, 2022 (estimated)
Last update
Jul 12, 2021

Study contacts

Mohamed M Hamed, BDS
Contact
mohamedhamed628@gmail.com
01023888701 ext. 002

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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