Modified Fixed BridgeNCT07752147
3D Printed vs CAD/CAM Rehabilitation of Primary Anterior Teeth Loss
A study testing 3D Printed modified fixed bridge and CAD/CAM fabricated modified fixed bridge in people with Modified Fixed Bridge, run by Tanta University at 1 site in Egypt.
Trial summary
compare 3D Printed versus CAD/CAM fabricated modified fixed appliance for rehabilitation of premature loss of anterior teeth in preschool children Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Modified Fixed Bridge
- What is being tested?
- 3D Printed modified fixed bridge and CAD/CAM fabricated modified fixed bridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jul 2025to 3 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children (ASA I or II)
- Premature loss of one to four maxillary primary incisors
- At least 6 months remaining before the expected eruption of the permanent successor
- Presence of sufficient healthy abutment teeth (primary canines)
- Adequate oral hygiene (Plaque Index ≤1).
- Cooperative child (Frankl Behavior Rating 3, 4).
Who cannot join
- Children with craniofacial anomalies or syndromes (e.g., cleft lip and palate).
- Children with developmental dental anomalies affecting the anterior region (e.g., hypodontia, severe enamel defects).
- Severe gingivitis or periodontal disease around the abutment teeth.
- Deep bite, severe malocclusion, or traumatic occlusion that could interfere with appliance function.
- Parafunctional habits that could increase appliance failure( Bruxism, Nail biting, Biting hard objects).
- Persistent oral habits that may affect appliance stability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of 3D Printed vs CAD/CAM Rehabilitation of Primary Anterior Teeth Loss
compare 3D Printed versus CAD/CAM fabricated modified fixed appliance for rehabilitation of premature loss of anterior teeth in preschool children
Read the detailed description
The study will be conducted as a clinical trial and it will be carried out at Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. Forty preschool children from both genders aged from 3-5 years will be included in the study. The selected children will be divided into two groups.
Group I: Twenty children will receive 3D Printed modified fixed bridge. Group II: Twenty will receive CAD/CAM fabricated modified fixed bridge. Evaluation of both appliances will be carried out at baseline, 6 and 12 months
- Conditions
- Modified Fixed Bridge
- Being tested
- 3D Printed modified fixed bridge, CAD/CAM fabricated modified fixed bridge
- Keywords
- 3D Printed, CAD/CAM, modified fixed bridge, anterior teeth loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed modified fixed bridgeDevice
the 3D Printed modified fixed appliances compared to CAD/CAM fabricated ones for rehabilitation of premature loss of anterior teeth
CAD/CAM fabricated modified fixed bridgeDevice
the CAD/CAM fabricated modified fixed bridge used a active control
| Study group | Role | What they receive |
|---|---|---|
| 3D Printed modified fixed bridge | Experimental | the modified fixed bridges were fabricated using 3D Printing technology Receives: Device: 3D Printed modified fixed bridge |
| CAD/CAM fabricated modified fixed bridge | Active comparator | the modified fixed bridges were fabricated using CAD/CAM technology Receives: Device: CAD/CAM fabricated modified fixed bridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical survival rate
Debonding, breakage of appliance ( failure causes)
Measured: 12 months
Gingival health
Gingival index will be assessed by clinician
Measured: 12 months
Esthetic evaluation
child and parent evaluation of restoring child esthetics using visual analog scale
Measured: 12 months
Secondary outcomes (1)
Questionnaire
determine whether one appliance provides greater improvements in: Eating and chewing ability, Speech, Smile appearance, Child confidence and social interaction, Parent satisfaction and reduced family concern.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start11 Jul 2025
- Primary completion13 Jul 2026
- Study completion3 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Modified Fixed BridgeStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nora mostafa mohammed abo shanady, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752147
- Sponsor's protocol ID
- #R-PED-11-25-3235
- Status last verified
- Sep 2026
- First submitted
- 3 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghaly M, Hamila NA. Evaluation of anterior fixed appliances on maxillary arch growth in preschool children. Sci Rep. 2025 Jan 29;15(1):3628. doi: 10.1038/s41598-025-87005-8.
PubMed 39880849
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 3D Printed vs CAD/CAM Rehabilitation of Primary Anterior Teeth Loss
- ClinicalTrials.gov ID
- NCT07752147
- Acronym / sponsor ID
- #R-PED-11-25-3235
- Conditions
- Modified Fixed Bridge
- Keywords
- 3D Printed, CAD/CAM, modified fixed bridge, anterior teeth loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 3 Oct 2026 (estimated)
- First posted
- 7 Aug 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.
compare 3D Printed versus CAD/CAM fabricated modified fixed appliance for rehabilitation of premature loss of anterior teeth in preschool children
Detailed description
The study will be conducted as a clinical trial and it will be carried out at Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. Forty preschool children from both genders aged from 3-5 years will be included in the study. The selected children will be divided into two groups.
Group I: Twenty children will receive 3D Printed modified fixed bridge. Group II: Twenty will receive CAD/CAM fabricated modified fixed bridge. Evaluation of both appliances will be carried out at baseline, 6 and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Printed modified fixed bridge | Experimental | Device: 3D Printed modified fixed bridgethe modified fixed bridges were fabricated using 3D Printing technology |
| CAD/CAM fabricated modified fixed bridge | Active comparator | Device: CAD/CAM fabricated modified fixed bridgethe modified fixed bridges were fabricated using CAD/CAM technology |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy children (ASA I or II)
- Premature loss of one to four maxillary primary incisors
- At least 6 months remaining before the expected eruption of the permanent successor
- Presence of sufficient healthy abutment teeth (primary canines)
- Adequate oral hygiene (Plaque Index ≤1).
Key exclusion criteria (6 listed)
- Children with craniofacial anomalies or syndromes (e.g., cleft lip and palate).
- Children with developmental dental anomalies affecting the anterior region (e.g., hypodontia, severe enamel defects).
- Severe gingivitis or periodontal disease around the abutment teeth.
- Deep bite, severe malocclusion, or traumatic occlusion that could interfere with appliance function.
- Parafunctional habits that could increase appliance failure( Bruxism, Nail biting, Biting hard objects).
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 |
|---|---|---|
| 3D Printed modified fixed bridgethe 3D Printed modified fixed appliances compared to CAD/CAM fabricated ones for rehabilitation of premature loss of anterior teeth | Device | 3D Printed modified fixed bridge |
| CAD/CAM fabricated modified fixed bridgethe CAD/CAM fabricated modified fixed bridge used a active control | Device | CAD/CAM fabricated modified fixed bridge |
Primary outcome
Clinical survival rate
Time frame: 12 months
Debonding, breakage of appliance ( failure causes)
Gingival health
Time frame: 12 months
Gingival index will be assessed by clinician
Esthetic evaluation
Time frame: 12 months
child and parent evaluation of restoring child esthetics using visual analog scale
1 secondary outcome
Questionnaire
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Results publication: PubMed 39880849Ghaly M, Hamila NA. Evaluation of anterior fixed appliances on maxillary arch growth in preschool children. Sci Rep. 2025 Jan 29;15(1):3628. doi: 10.1038/s41598-025-87005-8.
- Individual participant dataSharing planned: No
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 3D Printed modified fixed bridge and CAD/CAM fabricated modified fixed bridge in people with Modified Fixed Bridge, run by Tanta 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical survival rate (time frame: 12 months). The study lists 3 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 NCT07752147, which also lists 1 linked publication.
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 2026.