Missing TeethNCT06082544
Mini Screw Implant Supported Pontics Versus Removable Partial Dentures For Restoring Missing Permanent Anterior Teeth
A study testing mini-screw implant and removable partial denture in people with Missing Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
Loss of teeth leads to loss of function and lack of normal alveolar growth, along with unpleasant esthetics that hamper the psychosocial development of the young child. Traditionally, the management of single tooth loss in a young child is done by conservative means. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- mini-screw implant and removable partial denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Sep 2025
- 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Cooperative children.
- 9:14 years old children.
- Children with missing anterior permanent teeth either due to caries, trauma (at least 4 months after missing the tooth) or congenitally missed.
Who cannot join
- Children with physical or emotional alteration.
- Children with systemic diseases.
- Children of parents who don't accept to participate in the study.
- Very thin ridge
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Cairo University
Giza, Al Manial, 11562
Eman A Abdelhameed, MD, 01002552228, eman.adel@dentistry.cu.edu.eg
Gihan M Abuelniel, PHD, Gihan.Abuelniel@dentistry.cu.edu.eg
About this study
Official title: Clinical And Radiographic Success Of Mini Screw Implant Supported Pontics Versus Removable Partial Dentures For Restoring Missing Permanent Anterior Teeth: Randomized Clinical Trial
Loss of teeth leads to loss of function and lack of normal alveolar growth, along with unpleasant esthetics that hamper the psychosocial development of the young child. Traditionally, the management of single tooth loss in a young child is done by conservative means. The presence of large pulp chambers in incompletely mineralized immature teeth of children predisposes the pulp to loss of vitality in cases of complete coverage restorations . Hence, the clinician resorts to partial coverage prostheses such as Maryland Bridge, resin-bonded restorations, or removable prostheses in cases of multiple missing teeth. None of these treatment methods are completely satisfactory and have their drawbacks.
Partial dentures are dependent on the child's compliance. They increase the rate of decay and may cause gingival disease leading to bone resorption. Furthermore, there is a need to refabricate a new prosthesis from time to time to compensate for craniofacial growth.
Mini-screw implant placement in a young child would be an ideal method of treatment for the absence of teeth. They restore the function, preserve the alveolar bone, and give excellent esthetics, restoring the child's confidence and social acceptability. Parents are usually keen to get this treatment done as soon as offer the suggestion. To our knowledge, there is no previous study that compared the two techniques. The limited evidence shows that mini-screw implants supported pontics are useful transitional restorations for missing permanent maxillary incisors in children and adolescents; however, further well-designed clinical trials are needed in this regard. As a result, this study will be conducted to fill the gap of knowledge.
Read the detailed description
Rationale for conducting the research Mini- screw implant prosthetic rehabilitation seems to be a viable and promising option for provisional rehabilitation of growing patients, since it seems to preserve the bone structure while restoring function and esthetics until growth ceases, when then mini-screw implants can be replaced by standard implants.
Benefits for the practitioner:
- Providing new and alternative treatment options for restoring missing permanent anterior teeth with fixed mini-screw implant supported pontics.
- Increasing the compliance of the patients.
Benefits for the patient:
- Re-establish esthetic and appearance.
- Maintenance of space.
- Re-establishing occlusal relationships.
- Improving phonetics.
- Improving patients tolerance.
- Improvement in patient as well as parent satisfaction.
Benefits for community:
- Using alternative technique that can be fixed, with a better success rate.
- To boost overall oral health.
- Conditions
- Missing Teeth
- Being tested
- mini-screw implant, removable partial denture
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini-screw implantOther
JEIL SCREW 1.6* 8 MM 16-G2-008 or JEIL SCREW 1.6*10 MM 14-G2-010
removable partial dentureDevice
Acrylic removable partial denture
| Study group | Role | What they receive |
|---|---|---|
| Mini-screw implant-supported pontics placed palatally perpendicular to the alveolar ridge | Experimental | Mini-screw implant-supported pontics placed palatally perpendicular to the alveolar ridge (horizontally placed) using JEIL SCREW 1.6*8 MM 16-G2-008 Receives: Other: mini-screw implant |
| Mini screw implant supported pontics placed at the crest of the ridge | Experimental | Mini screw implant supported pontics placed at the crest of the ridge (vertically placed) using JEIL SCREW 1.6* 10 MM 14-G2-f010 Receives: Other: mini-screw implant |
| Removable partial denture. | Active comparator | removable partial denture with conventional technique Receives: Device: removable partial denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
visual analogue scale (VAS) continuous from 0-10 (0 not satisfied at all and 10 is satisfied)
Measured: 3,6,9,12 months
adverse effects
denture fracture, denture loss, denture remake, looseness of the screw, fracture of the screw, pontic displacement, fracture of the pontic and discoloration of the pontic
Measured: 3,6,9,12 months
Secondary outcomes (2)
vertical bone resorption
parallel technique using periapical radiograph
Measured: 1 year
horizontal bone resorption
Cone beam computed tomography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- More trials run by Cairo 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
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Adel Abd Elhameed, Cairo University
- Investigators
- Eman A Abdelhameed, MD, Principal investigator, Assistant lecturer at Pediatric Dentistry and Dental Public Health DepartmentGihan M Abuelniel, PHD, Study director, Professor at Pediatric Dentistry and Dental Public Health DepartmentAhmed H El Khadem, PHD, Study director, Associate Professor at Pediatric Dentistry and Dental Public Health DepartmentMaii M Mohamed, PHD, Study director, Lecturer at Pediatric Dentistry and Dental Public Health DepartmentAhmed M Abdel Samad, PHD, Study director, Professor at Oral and Maxillofacial Radiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082544
- Sponsor's protocol ID
- 29208130101509
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Radiographic Success Of Mini Screw Implant Supported Pontics Versus Removable Partial Dentures For Restoring Missing Permanent Anterior Teeth: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06082544
- Acronym / sponsor ID
- 29208130101509
- Conditions
- Missing Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 13 Oct 2023 (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.
Loss of teeth leads to loss of function and lack of normal alveolar growth, along with unpleasant esthetics that hamper the psychosocial development of the young child. Traditionally, the management of single tooth loss in a young child is done by conservative means. The presence of large pulp chambers in incompletely mineralized immature teeth of children predisposes the pulp to loss of vitality in cases of complete coverage restorations . Hence, the clinician resorts to partial coverage prostheses such as Maryland Bridge, resin-bonded restorations, or removable prostheses in cases of multiple missing teeth. None of these treatment methods are completely satisfactory and have their drawbacks.
Partial dentures are dependent on the child's compliance. They increase the rate of decay and may cause gingival disease leading to bone resorption. Furthermore, there is a need to refabricate a new prosthesis from time to time to compensate for craniofacial growth.
Mini-screw implant placement in a young child would be an ideal method of treatment for the absence of teeth. They restore the function, preserve the alveolar bone, and give excellent esthetics, restoring the child's confidence and social acceptability. Parents are usually keen to get this treatment done as soon as offer the suggestion. To our knowledge, there is no previous study that compared the two techniques. The limited evidence shows that mini-screw implants supported pontics are useful transitional restorations for missing permanent maxillary incisors in children and adolescents; however, further well-designed clinical trials are needed in this regard. As a result, this study will be conducted to fill the gap of knowledge.
Detailed description
Rationale for conducting the research Mini- screw implant prosthetic rehabilitation seems to be a viable and promising option for provisional rehabilitation of growing patients, since it seems to preserve the bone structure while restoring function and esthetics until growth ceases, when then mini-screw implants can be replaced by standard implants.
Benefits for the practitioner:
- Providing new and alternative treatment options for restoring missing permanent anterior teeth with fixed mini-screw implant supported pontics.
- Increasing the compliance of the patients.
Benefits for the patient:
- Re-establish esthetic and appearance.
- Maintenance of space.
- Re-establishing occlusal relationships.
- Improving phonetics.
- Improving patients tolerance.
- Improvement in patient as well as parent satisfaction.
Benefits for community:
- Using alternative technique that can be fixed, with a better success rate.
- To boost overall oral health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mini-screw implant-supported pontics placed palatally perpendicular to the alveolar ridge | Experimental | Other: mini-screw implantMini-screw implant-supported pontics placed palatally perpendicular to the alveolar ridge (horizontally placed) using JEIL SCREW 1.6*8 MM 16-G2-008 |
| Mini screw implant supported pontics placed at the crest of the ridge | Experimental | Other: mini-screw implantMini screw implant supported pontics placed at the crest of the ridge (vertically placed) using JEIL SCREW 1.6* 10 MM 14-G2-f010 |
| Removable partial denture. | Active comparator | Device: removable partial dentureremovable partial denture with conventional technique |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Cooperative children.
Key exclusion criteria (4 listed)
- Children with physical or emotional alteration.
- Children with systemic diseases.
- Children of parents who don't accept to participate in the study.
- Very thin ridge
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 |
|---|---|---|
| mini-screw implantJEIL SCREW 1.6* 8 MM 16-G2-008 or JEIL SCREW 1.6*10 MM 14-G2-010 | Other | Mini screw implant supported pontics placed at the crest of the ridge, Mini-screw implant-supported pontics placed palatally perpendicular to the alveolar ridge |
| removable partial dentureAcrylic removable partial denture | Device | Removable partial denture. |
Primary outcome
patient satisfaction
Time frame: 3,6,9,12 months
visual analogue scale (VAS) continuous from 0-10 (0 not satisfied at all and 10 is satisfied)
adverse effects
Time frame: 3,6,9,12 months
denture fracture, denture loss, denture remake, looseness of the screw, fracture of the screw, pontic displacement, fracture of the pontic and discoloration of the pontic
2 secondary outcomes
vertical bone resorption
Time frame: 1 year
horizontal bone resorption
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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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.
Eman A Abdelhameed, MD principal investigator
Assistant lecturer at Pediatric Dentistry and Dental Public Health Department
Gihan M Abuelniel, PHD study director
Professor at Pediatric Dentistry and Dental Public Health Department
Ahmed H El Khadem, PHD study director
Associate Professor at Pediatric Dentistry and Dental Public Health Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mini-screw implant and removable partial denture in people with Missing Teeth, run by Cairo 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 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: status not confirmed, as of the sponsor's last update on 18 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman A Abdelhameed, MD (01002552228, eman.adel@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: 3,6,9,12 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?
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 18 Oct 2023.