CariesFPMNCT06231823
Extraction of the Compromised First Permanent Molars
A study testing Extraction in people with Caries and Caries,Dental, run by Ain Shams University at 1 site in Egypt.
Trial summary
Compromised first permanent molars (FPM), whether diagnosed with severe molar incisor hypomineralization (MIH), irreversible pulpities, or necrosis, require frequent re-treatment consequently entering the restorative cycle, which leads to their inevitable extraction and implant placement. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Caries,Dental
- What is being tested?
- Extraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to Mar 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy patients\' class I according to the American Society of Anesthesiologists (ASA class I)
- Age: 8-10 years
- Angle class I occlusion
- The radiographic presence of the second premolar
- The radiographic stages of development E or F for formation the second permanent molar.
- First permanent molar that is severely affected by MIH, signs of necrosis, signs of irreversible pulpitis or non-restorability.
Who cannot join
- Refusal of the parents to sign the informed consent.
- Signs of reversible pulpitis of first permanent molar.
- Patients with severe malocclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Extraction of Compromised First Permanent Molars in a Group of Egyptian Children
Compromised first permanent molars (FPM), whether diagnosed with severe molar incisor hypomineralization (MIH), irreversible pulpities, or necrosis, require frequent re-treatment consequently entering the restorative cycle, which leads to their inevitable extraction and implant placement. Extraction of compromised first permanent molars in 8-10-year-old children allows the mesial migration of the second permanent molars during their eruption, thereby favoring spontaneous space closure as a permanent solution.
Read the detailed description
Extraction of compromised first permanent molars in children decreases the burden of repeated restorative procedures for theses molars, which will eventually need frequent repair. This will end in their inevitable extraction with its consequences. The extraction of the FPM will be delivered by Nour Wahba, Dina Darwish, and Basma Nagi, lecturers in Pediatric Dentistry and Dental Public Health Department, faculty of Dentistry, Ain Shams University.All patients will be recalled for follow-up yearly for three-years. The first follow-up will be done after 6months to perform the Quality of life questionnaires. The position of the second permanent molar will be checked clinically and radiographically to evaluate the space between second premolar and the second molar.
- Conditions
- Caries, Caries,Dental
- Being tested
- Extraction
- Keywords
- first permanent molar, molar incisor hypo mineralization, dental extraction, space closure
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExtractionOther
Simple / surgical dental extraction for necrotic. irreversible pulpitis, unrestorable, and first permanent molars with sever molar incisor hypomineralization.
| Study group | Role | What they receive |
|---|---|---|
| extraction of the compromised first permanent molars at 8-10 years children | Experimental | extraction of badly decayed FPM at the E,F developmental stages of the second permanent molar. Receives: Other: Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical spontaneous space closure
Clinically, using periodontal probe measure the amount of space between the distal surface of second premolar and mesial surface of second permanent molar.
Measured: 3 years
radiographic spontaneous space closure
radiographically, using panoramic radiograph
Measured: 3 years
Secondary outcomes (2)
assessment of the Quality of life
Measure the quality of life of the children before extraction and at 6 months follow-up using parent perception questionnaire and family impact scale (P-CPQ and FIS) and child perception questionnaire 8- 10 or 11-14 (CPQ 8-10; CPQ 11-14) according to the child's age.
Measured: 6 months
Midline shift
Investigate the midline shift by clinical examination.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Jan 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dina darwish, Ain Shams University
- Investigators
- Dina D Abdelmoneim, Principal investigator, Ain Shams Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231823
- Sponsor's protocol ID
- FDASU-RecIR012364
- Acronym
- FPM
- Status last verified
- Feb 2025
- First submitted
- 15 Jan 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Extraction of Compromised First Permanent Molars in a Group of Egyptian Children
- ClinicalTrials.gov ID
- NCT06231823
- Acronym / sponsor ID
- FPM / FDASU-RecIR012364
- Conditions
- Caries, Caries,Dental
- Keywords
- first permanent molar, molar incisor hypo mineralization, dental extraction, space closure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 30 Jan 2024 (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.
Compromised first permanent molars (FPM), whether diagnosed with severe molar incisor hypomineralization (MIH), irreversible pulpities, or necrosis, require frequent re-treatment consequently entering the restorative cycle, which leads to their inevitable extraction and implant placement. Extraction of compromised first permanent molars in 8-10-year-old children allows the mesial migration of the second permanent molars during their eruption, thereby favoring spontaneous space closure as a permanent solution.
Detailed description
Extraction of compromised first permanent molars in children decreases the burden of repeated restorative procedures for theses molars, which will eventually need frequent repair. This will end in their inevitable extraction with its consequences. The extraction of the FPM will be delivered by Nour Wahba, Dina Darwish, and Basma Nagi, lecturers in Pediatric Dentistry and Dental Public Health Department, faculty of Dentistry, Ain Shams University.All patients will be recalled for follow-up yearly for three-years. The first follow-up will be done after 6months to perform the Quality of life questionnaires. The position of the second permanent molar will be checked clinically and radiographically to evaluate the space between second premolar and the second molar.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| extraction of the compromised first permanent molars at 8-10 years children | Experimental | Other: Extractionextraction of badly decayed FPM at the E,F developmental stages of the second permanent molar. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy patients\' class I according to the American Society of Anesthesiologists (ASA class I)
- Age: 8-10 years
- Angle class I occlusion
- The radiographic presence of the second premolar
- The radiographic stages of development E or F for formation the second permanent molar.
Key exclusion criteria (3 listed)
- Refusal of the parents to sign the informed consent.
- Signs of reversible pulpitis of first permanent molar.
- Patients with severe malocclusion.
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 |
|---|---|---|
| ExtractionSimple / surgical dental extraction for necrotic. irreversible pulpitis, unrestorable, and first permanent molars with sever molar incisor hypomineralization. | Other | extraction of the compromised first permanent molars at 8-10 years children |
Primary outcome
clinical spontaneous space closure
Time frame: 3 years
Clinically, using periodontal probe measure the amount of space between the distal surface of second premolar and mesial surface of second permanent molar.
radiographic spontaneous space closure
Time frame: 3 years
radiographically, using panoramic radiograph
2 secondary outcomes
assessment of the Quality of life
Time frame: 6 months
Midline shift
Time frame: 3 years
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 19 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Dina D Abdelmoneim principal investigator
Ain Shams Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraction in people with Caries and Caries,Dental, run by Ain Shams 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 3 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 19 Feb 2025. 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 spontaneous space closure (time frame: 3 years). 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 19 Feb 2025; AzTrials last refreshed its copy on 2 Nov 2026.