Premature Loss of Primary MolarsNCT06965777
Space Changes After Premature Loss of Lower First Primary Molars in Children Using Digital Scanning
An observational study of Premature Loss of Primary Molars and Space Maintenance, run by Cairo University at 1 site in Egypt.
Trial summary
This prospective split-mouth clinical study aims to evaluate space changes in the mandibular dental arch following premature extraction of the lower first primary molar in children aged 3 to 5.5 years. Read more about this study
- Who is it for?
- Ages 3 years to 66 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature Loss of Primary Molars, Space Maintenance, Dental Arch Development
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Mar 2026
- Phase
- Observational
- 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 years to 66 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 3 to 5.5 years attending the Pediatric Dentistry and Dental Public Health outpatient clinics at the Faculty of Dentistry, Cairo University, who require unilateral extraction of the mandibular first primary molar due to poor prognosis and meet the study's inclusion criteria.
Who may be able to join
- Children aged 3 to 5.5 years
- Mandibular first primary molar indicated for extraction due to extensive decay or hopeless prognosis
- Contralateral mandibular first primary molar must be intact and free of proximal caries
- No eruption of mandibular permanent first molar at the time of enrollment
- Presence of primary canines and second primary molars
- No space maintainers placed
- Parents/caregivers unable or unwilling to fabricate a space maintainer
Who cannot join
- Bilateral premature loss of mandibular first primary molars
- Contralateral mandibular molar has proximal caries or poor prognosis
- Children with good prognosis first primary molars (i.e., not needing extraction)
- Eruption of the mandibular permanent first molar
- Children who already have space maintainers
- Uncooperative behavior preventing study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Space Changes Following Premature Loss of Lower First Primary Molars in the Primary Dentition Stage Using Digital Scanning A Prospective Split-mouth Clinical Study
This prospective split-mouth clinical study aims to evaluate space changes in the mandibular dental arch following premature extraction of the lower first primary molar in children aged 3 to 5.5 years. Using digital 3D models, changes in the D space and mandibular arch perimeter will be measured at baseline and 6 months post-extraction. The goal is to determine whether space maintainers are necessary in the primary dentition stage.
Read the detailed description
Premature loss of primary molars in children is a common result of caries or trauma, potentially affecting future occlusion and alignment. This study investigates the space changes that occur after unilateral premature extraction of the mandibular first primary molar before the eruption of the permanent first molar. Using a split-mouth design, the contralateral non-extracted side serves as the control. Digital impressions will be taken at baseline (day of extraction) and after 6 months. The primary outcome is the change in the D space, and the secondary outcome is the change in the mandibular arch perimeter, both measured using 3D digital software. The study aims to provide evidence for or against the routine use of space maintainers in similar clinical scenarios, potentially reducing unnecessary treatment and improving patient comfort.
- Conditions
- Premature Loss of Primary Molars, Space Maintenance, Dental Arch Development, Pediatric Tooth Extraction
- Keywords
- Tooth Loss, Dental Arch, Pediatric Dentistry, Primary Dentition
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Split-mouth Observational Cohort | Children aged 3 to 5.5 years with one mandibular first primary molar extracted due to poor prognosis. The study compares space and arch perimeter changes between the extraction side and the contralateral intact side within the same patient over a 6-month follow-up period using digital 3D models. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in D Space (Mandibular Arch)
The change in D space (distance between the mesial midpoint of the second primary molar and the distal midpoint of the primary canine) on the extraction side of the mandibular arch. Measured in millimeters using 3D digital models.
Measured: Baseline (Day of Extraction) and 6 Months Post-Extraction
Secondary outcomes (1)
Change in Mandibular Arch Perimeter
The change in the total arch perimeter of the mandibular arch measured using 3D digital models. The arch perimeter is calculated as the sum of linear segments across reference tooth landmarks. Measured in millimeters.
Measured: Baseline (Day of Extraction) and 6 Months Post-Extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Loss of Primary MolarsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dania Yaser Rahhal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965777
- Sponsor's protocol ID
- SL&AP-CU
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data (IPD). All data collected will remain confidential and used solely for the purposes of this research. Any results presented will be in aggregate form, without disclosing participant-level data.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Space Changes Following Premature Loss of Lower First Primary Molars in the Primary Dentition Stage Using Digital Scanning A Prospective Split-mouth Clinical Study
- ClinicalTrials.gov ID
- NCT06965777
- Acronym / sponsor ID
- SL&AP-CU
- Conditions
- Premature Loss of Primary Molars, Space Maintenance, Dental Arch Development, Pediatric Tooth Extraction
- Keywords
- Tooth Loss, Dental Arch, Pediatric Dentistry, Primary Dentition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 11 May 2025 (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 prospective split-mouth clinical study aims to evaluate space changes in the mandibular dental arch following premature extraction of the lower first primary molar in children aged 3 to 5.5 years. Using digital 3D models, changes in the D space and mandibular arch perimeter will be measured at baseline and 6 months post-extraction. The goal is to determine whether space maintainers are necessary in the primary dentition stage.
Detailed description
Premature loss of primary molars in children is a common result of caries or trauma, potentially affecting future occlusion and alignment. This study investigates the space changes that occur after unilateral premature extraction of the mandibular first primary molar before the eruption of the permanent first molar. Using a split-mouth design, the contralateral non-extracted side serves as the control. Digital impressions will be taken at baseline (day of extraction) and after 6 months. The primary outcome is the change in the D space, and the secondary outcome is the change in the mandibular arch perimeter, both measured using 3D digital software. The study aims to provide evidence for or against the routine use of space maintainers in similar clinical scenarios, potentially reducing unnecessary treatment and improving patient comfort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Split-mouth Observational Cohort | – | –Children aged 3 to 5.5 years with one mandibular first primary molar extracted due to poor prognosis. The study compares space and arch perimeter changes between the extraction side and the contralateral intact side within the same patient over a 6-month follow-up period using digital 3D models. |
Who may qualify
- Ages
- 3 years to 66 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 3 to 5.5 years attending the Pediatric Dentistry and Dental Public Health outpatient clinics at the Faculty of Dentistry, Cairo University, who require unilateral extraction of the mandibular first primary molar due to poor prognosis and meet the study's inclusion criteria.
Key inclusion criteria (7 listed)
- Children aged 3 to 5.5 years
- Mandibular first primary molar indicated for extraction due to extensive decay or hopeless prognosis
- Contralateral mandibular first primary molar must be intact and free of proximal caries
- No eruption of mandibular permanent first molar at the time of enrollment
- Presence of primary canines and second primary molars
Key exclusion criteria (6 listed)
- Bilateral premature loss of mandibular first primary molars
- Contralateral mandibular molar has proximal caries or poor prognosis
- Children with good prognosis first primary molars (i.e., not needing extraction)
- Eruption of the mandibular permanent first molar
- Children who already have space maintainers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in D Space (Mandibular Arch)
Time frame: Baseline (Day of Extraction) and 6 Months Post-Extraction
The change in D space (distance between the mesial midpoint of the second primary molar and the distal midpoint of the primary canine) on the extraction side of the mandibular arch. Measured in millimeters using 3D digital models.
1 secondary outcome
Change in Mandibular Arch Perimeter
Time frame: Baseline (Day of Extraction) and 6 Months Post-Extraction
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 14 May 2025.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data (IPD). All data collected will remain confidential and used solely for the purposes of this research. Any results presented will be in aggregate form, without disclosing participant-level data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Loss of Primary Molars and Space Maintenance, 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 7 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: opening soon, as of the sponsor's last update on 14 May 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?
Contact Dania Yaser Rahhal Y Rahhal, BDS (+201029020795, dania.rahhal96@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in D Space (Mandibular Arch) (time frame: Baseline (Day of Extraction) and 6 Months Post-Extraction). 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 14 May 2025.