Clinical PerformanceNCT07916038
Clinical Performance of Polyetheretherketone-fabricated Versus Conventional Lingual Arch Space Maintainers
A study testing Peek-fabricated lingual arch space maintainer. and Traditional lingual arch space maintainer. in people with Clinical Performance and Polyetheretherketone, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aimed to evaluate and compare the clinical performance of peek-fabricated versus conventional lingual arch space maintainers. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Clinical Performance, Polyetheretherketone, Lingual Arch Space
- What is being tested?
- Peek-fabricated lingual arch space maintainer. and Traditional lingual arch space maintainer.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Feb 2026
- 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children aged 7-10 years old.
- Freshly extracted or severely mutilated primary molars bilateral requiring extraction.
- Sound first permanent molars.
- Angle's class I molar relationship of first permanent molars.
- No abnormal dental conditions such as crossbite, open bite, or deep bite.
Who cannot join
- Children exhibiting poor oral hygiene.
- Children with poor compliance in dental care.
- Uncontrolled rampant caries or extensive decay in the abutment teeth.
- Children with pernicious oral habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Evaluation of the Clinical Performance of Polyetheretherketone-fabricated Versus Conventional Lingual Arch Space Maintainers: A Randomized Clinical Trial
This study aimed to evaluate and compare the clinical performance of peek-fabricated versus conventional lingual arch space maintainers.
Read the detailed description
Early loss of primary teeth can lead to decreased arch length, crowding, midline deviation, impaction of permanent teeth, malocclusions, and degenerative and inflammatory problems in periodontal tissues due to tipping of the adjacent teeth.
Maintaining mesio-distal relations in the employed dental arch is the most important role of space maintainers. With space maintainers, complex orthodontic treatment is put off and the eruption of the permanent teeth is guided.
Conventional space maintainers have successfully maintained adequate space in the dental arches when a deciduous tooth has been prematurely extracted. However, digital progress, the use of CAD-CAM technology, along with the introduction of new 3D printed materials, are providing greater efficiency in obtaining the desired results.
- Being tested
- Peek-fabricated lingual arch space maintainer., Traditional lingual arch space maintainer.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peek-fabricated lingual arch space maintainer.Procedure or surgery
The space of missing mandibular primary molars was maintained by a peek-fabricated lingual arch space maintainer.
Traditional lingual arch space maintainer.Procedure or surgery
The space of missing mandibular primary molars was maintained by a traditional lingual arch space maintainer.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The space of missing mandibular primary molars was maintained by a peek-fabricated lingual arch space maintainer. Receives: Procedure: Peek-fabricated lingual arch space maintainer. |
| Group B | Experimental | The space of missing mandibular primary molars was maintained by a traditional lingual arch space maintainer. Receives: Procedure: Traditional lingual arch space maintainer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Lingual Arch Space Maintainers With Retention Loss
The percentage of lingual arch space maintainers exhibiting retention loss during the six-month follow-up was compared between the polyetheretherketone (PEEK) and conventional appliance groups. Appliances was clinically examined at 1, 3, and 6 months after placement.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Aug 2024
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PerformanceStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Rady abdelmonem, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916038
- Sponsor's protocol ID
- 1109/3831
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of the Clinical Performance of Polyetheretherketone-fabricated Versus Conventional Lingual Arch Space Maintainers: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07916038
- Acronym / sponsor ID
- 1109/3831
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate and compare the clinical performance of peek-fabricated versus conventional lingual arch space maintainers.
Detailed description
Early loss of primary teeth can lead to decreased arch length, crowding, midline deviation, impaction of permanent teeth, malocclusions, and degenerative and inflammatory problems in periodontal tissues due to tipping of the adjacent teeth.
Maintaining mesio-distal relations in the employed dental arch is the most important role of space maintainers. With space maintainers, complex orthodontic treatment is put off and the eruption of the permanent teeth is guided.
Conventional space maintainers have successfully maintained adequate space in the dental arches when a deciduous tooth has been prematurely extracted. However, digital progress, the use of CAD-CAM technology, along with the introduction of new 3D printed materials, are providing greater efficiency in obtaining the desired results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Peek-fabricated lingual arch space maintainer.The space of missing mandibular primary molars was maintained by a peek-fabricated lingual arch space maintainer. |
| Group B | Experimental | Procedure: Traditional lingual arch space maintainer.The space of missing mandibular primary molars was maintained by a traditional lingual arch space maintainer. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children aged 7-10 years old.
- Freshly extracted or severely mutilated primary molars bilateral requiring extraction.
- Sound first permanent molars.
- Angle's class I molar relationship of first permanent molars.
- No abnormal dental conditions such as crossbite, open bite, or deep bite.
Key exclusion criteria (4 listed)
- Children exhibiting poor oral hygiene.
- Children with poor compliance in dental care.
- Uncontrolled rampant caries or extensive decay in the abutment teeth.
- Children with pernicious oral habits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peek-fabricated lingual arch space maintainer.The space of missing mandibular primary molars was maintained by a peek-fabricated lingual arch space maintainer. | Procedure or surgery | Group A |
| Traditional lingual arch space maintainer.The space of missing mandibular primary molars was maintained by a traditional lingual arch space maintainer. | Procedure or surgery | Group B |
Primary outcome
Percentage of Lingual Arch Space Maintainers With Retention Loss
Time frame: 6 months post-procedure
The percentage of lingual arch space maintainers exhibiting retention loss during the six-month follow-up was compared between the polyetheretherketone (PEEK) and conventional appliance groups. Appliances was clinically examined at 1, 3, and 6 months after placement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peek-fabricated lingual arch space maintainer. and Traditional lingual arch space maintainer. in people with Clinical Performance and Polyetheretherketone, run by Al-Azhar 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 5 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 4 Nov 2026. 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?
Percentage of Lingual Arch Space Maintainers With Retention Loss (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.