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New shell system aims to rebuild jawbone for dental implants

NCT ID NCT06295055

Disease control Sponsor: Prince of Songkla University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests a semi-rigid shell barrier system to help grow new bone in the jaw for people who need dental implants. Ten adults with moderate to severe bone loss will receive the shell with bone graft material. Researchers will measure bone growth and safety over 4 months using scans and tissue samples.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
semi-rigid shell barrier system (a device used with bone graft particles and a covering membrane)
What this could lead to
If successful, this could offer a reliable way to rebuild jawbone for dental implants in people with moderate to severe bone loss.
What could go wrong
This is a very small early study with only 10 participants and no comparison group, so results may not apply widely. The procedure involves surgery and there is a risk the bone may not grow as expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Oct 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * subjects requiring a bone defect between 3 to 8 millimeters (moderate to severe bone defect) covered 1-2 tooth span with adjacent tooth * Planned for dental implant and fixed prosthesis * Aged 20 and above but under the age of 65 with good physical health and good oral hygiene * Able to comprehend and are willing to sign the consent form and can adhere to the protocol including scheduled clinic visits and assigned treatment. * Available for follow-up after implant placement. Exclusion Criteria: * (i) Heavy smokers (\>10 cigarettes/day) * (ii) receiving bisphosphonates * (iii) undergoing radiotherapy * (iv) uncontrolled medical conditions * (v) Alcoholism * (vi) Pregnancy.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bone formation Guided bone regeneration

Contacts and locations

Locations

  • Prince of Songkla

    Songkhla, Hatyai, 90110, Thailand

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