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One implant or two? new study tests simpler denture solution

NCT ID NCT07408778

Symptom relief Sponsor: Rola Shadid Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two ways to secure lower dentures: using one implant or two implants. Researchers want to see if one implant can provide similar comfort, satisfaction, and chewing ability as two implants. The study involves 32 adults with no teeth who already have upper and lower dentures but are unhappy with how the lower one fits. Participants will be randomly assigned to receive either one or two implants, and their quality of life, satisfaction, and chewing performance will be tracked for one year.

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 32 people

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

Started

Feb 2026

Expected to finish

Jul 2027

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

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Men and women ≥40 years. * ASA I-II; favorable general health or adequately controlled systemic disease (e.g., hypertension, diabetes). * Skeletal Class I relationship. * Completely edentulous mandible and maxilla. * Technically acceptable complete dentures in both jaws for ≥3 and ≤24 months; dissatisfaction limited to mandibular retention/stability. * Adequate anterior mandibular bone for implant ≥3.5×10 mm confirmed on CBCT; no bone augmentation needed. * Normal mucosal resilience (\~2 mm displacement). * Implant sites healed ≥4 months since extraction. * Willingness to be randomized and attend follow-ups; written informed consent. * Primary stability target ≥25 N-cm. Exclusion Criteria: * Uncontrolled systemic disease; neurodegenerative disease; osteoporosis requiring antiresorptives. * Chronic systemic antibiotics/steroids; bleeding disorders; active cancer therapy; metabolic bone disease; HIV. * Investigational drug use within 30 days. * Alcohol dependence/illicit drug use; xerostomia (stimulated flow \<0.7 mL/min). * Heavy smoking \>20 cigarettes/day. * TMD/orofacial pain; severe bruxism; moderate/severe cognitive impairment. * Prior implant therapy. * Non-adherence risk or inability to attend longitudinal visits. * Insufficient prosthetic space for attachment housing: inter-arch vertical distance \<8.5 mm at parasymphyseal/canine region. * Concurrent participation in another interventional study. * Erosive lichen planus or other significant oral mucosal disease; head-and-neck irradiation history. * Mandibular pathology on CBCT (e.g., cyst, tumor). * Ridge dimensions \<6 mm width or \<10 mm height at planned sites. * Active intraoral infection.

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Conditions

The condition(s) this trial relates to.

anodontia

As listed by the trial registrant

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

Edentulism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Faculty of Dentistry/ Arab American University

    RECRUITING

    Jenin, Palestine, 240 jenin, Palestinian Territories

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