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Immediate ImplantsNCT03987646

The Vestibular Socket Therapy : A Novel Concept for Immediate Implant Placement in Defective Fresh Extraction Sites

A study testing Non-staged vestibular fresh socket therapy in people with Immediate Implants, run by Nourhan M.Aly at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This article aims to provide a non- staged treatment protocol to placing dental implants in compromised fresh sockets in the aesthetic zone. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Immediate Implants
What is being tested?
Non-staged vestibular fresh socket therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteEgypt
Study dates
24 May 2018to 8 Aug 2019
Phase
Interventional
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 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • A hopeless single tooth in the maxillary anterior region
  • Sufficient apical bone to allow adequate anchorage/primary stability of the implant
  • had natural teeth present adjacent to the tooth being replaced

Who cannot join

  • Presence of acute infection
  • Impossibility of reaching adequate implant primary stability in the native
  • Smokers of > 10 cigarettes
  • Antitumor chemotherapy or radiotherapy in the previous year

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Private Practice Clinic

    Alexandria

Other trials in Egypt

About this study

This article aims to provide a non- staged treatment protocol to placing dental implants in compromised fresh sockets in the aesthetic zone.

Read the detailed description

This is a site-specific therapy uses study a slowly resorbing regenerative barrier (shield) to augment any thin or deficient labial plate of bone, enhances the overlying soft tissue quality and quantity at the same time with implant fixture placement using a computer-guided surgical template.

Being tested
Non-staged vestibular fresh socket therapy
Keywords
xenograft cortical flexible sheet, fresh extraction socket

What participants receive

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

  • Non-staged vestibular fresh socket therapyProcedure or surgery

    Also called osteoflex

    a slowly resorbable membrane shield is placed above the labial plate of bone so that when the thin labial plate started its resorption process the shield remains till a complete gap fill occurred thus leading to a thicker labial plate of bone or it preserves the socket architecture until a complete bone fill occurred inside the socket

Study groups in NCT03987646
Study groupRoleWhat they receive
xenograft cortical flexible sheetExperimentala-traumatic tooth removal , socket lavage and curettage, performing a vestibular access horizontal incision corresponding to the socket 3-4 mm apically from the muccogingival junction , a tunnel is then created from the socket office and extended apically till it connects with the vestibular access incision, a computer guided surgical template is then used to deliver the implant in its optimal position, a slowly resorbable membrane shield is then introduced through the tunnel and stabilized with a membrane tac , it is a sturdy fixable membrane barrier placed above the labial plate
Receives: Procedure: Non-staged vestibular fresh socket therapy

What is being measured

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

  1. radiographic buccal bone thickness

    preoperative and follow up CBCTs are superimposed on each other and buccal bone thickness is measure at 3 similar points on both CBCTs and then a mean is calculated

    Measured: 6 months

  2. radiographic buccal bone height

    preoperative and follow up CBCTs are superimposed on each other and buccal bone height is measured in relation to implant shoulder level

    Measured: 6 months

Secondary outcomes (1)

  1. final esthetic outcome of soft tissue

    Pink esthetic score. based on subjective assessment of mesial papilla, distal papilla, midfacial level, midfacial contour, alveolar process deficiency, soft tissue color and texture. each item is given a score between 0 and 2, where 0 is the worst and 2 is the best outcome. Then, a final score ranging between 0-14 is calculated

    Measured: 6 months

Timeline

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

  1. First posted17 Jun 2019
  2. Study start24 May 2018
  3. Primary completion10 Jun 2019
  4. Study completion8 Aug 2019

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03987646
Sponsor's protocol ID
nonstaged socket therapy
Status last verified
Sep 2019
First submitted
12 Jun 2019
Last updated
25 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.

    PubMed 24660198

  • Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217.

    PubMed 19885446

  • Meijer HJA, Slagter KW, Vissink A, Raghoebar GM. Buccal bone thickness at dental implants in the maxillary anterior region with large bony defects at time of immediate implant placement: A 1-year cohort study. Clin Implant Dent Relat Res. 2019 Feb;21(1):73-79. doi: 10.1111/cid.12701. Epub 2018 Dec 11.

    PubMed 30548160

  • Barroso-Panella A, Gargallo-Albiol J, Hernandez-Alfaro F. Evaluation of Bone Stability and Esthetic Results After Immediate Implant Placement Using a Novel Synthetic Bone Substitute in the Anterior Zone: Results After 12 Months. Int J Periodontics Restorative Dent. 2018 Mar/Apr;38(2):235-243. doi: 10.11607/prd.2863.

    PubMed 29447317

Questions about this trial

What is this clinical trial studying?

A study testing Non-staged vestibular fresh socket therapy in people with Immediate Implants, run by Nourhan M.Aly 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 3 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: finished, as of the sponsor's last update on 25 Sep 2019. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

radiographic buccal bone thickness (time frame: 6 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 NCT03987646, which also lists 4 linked publications.

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 25 Sep 2019.

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