Physiological Root Resorption of Primary TeethNCT07834814
The Effect of Physiological Root Resorption in Primary Teeth on the Success of Pulpotomy Treatment
An observational study of Physiological Root Resorption of Primary Teeth, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to evaluate the effect of physiological root resorption on the success of pulpotomy treatment performed using a calcium silicate-based material on primary second molars with deep dentin caries. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Physiological Root Resorption of Primary Teeth
- What is being tested?
- Pulpotomy treatment
- Type of treatment
- Surgery or procedure
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2023to 2 Apr 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 4 to 11 years
- All sexes
- Child
Study population: Children presenting to the Department of Pediatric Dentistry at Uşak University Faculty of Dentistry for routine examination or treatment.
Inclusion Criteria: Children who scored 3 or 4 on the Frankl Behavior Scale, had good oral hygiene habits, had parental consent, and voluntarily agreed to participate in the study were included, provided they had no systemic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Physiological Root Resorption in Primary Teeth on the Success of Pulpotomy Treatment: A Prospective, Observational, Two-arm Comparative Cohort Study
The aim of our study was to evaluate the effect of physiological root resorption on the success of pulpotomy treatment performed using a calcium silicate-based material on primary second molars with deep dentin caries. The study included 93 patients (41 girls, 52 boys) aged 4-11 years with deep dentin caries in their lower primary second molars. Patients were divided into two groups based on the status of physiological root resorption in the primary molar to be treated. The control group (Group 1) consisted of lower second primary molars in which physiological root resorption had not yet begun (n=44), while the study group (Group 2) consisted of lower second primary molars in which physiological root resorption had reached the one-third level of the root (n=49). Patients were called in for follow-up appointments after treatment, and clinical follow-ups were performed at 1, 3, 6, and 12 months, while radiographic follow-ups were conducted at 6 and 12 months.
- Being tested
- Pulpotomy treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpotomy treatmentProcedure or surgery
Pulpotomy treatment performed using a calcium silicate-based material
| Study group | Role | What they receive |
|---|---|---|
| Physiological root resorption | Not described Receives: Procedure: Pulpotomy treatment | |
| Without physiological root resorption | Not described Receives: Procedure: Pulpotomy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success Rate
Clinical Success Criteria: Absence of pain, tenderness, pathological mobility, fistula/abscess, or swelling in the periodontal tissues.
Radiographic Success Criteria: Absence of pathological root resorption, internal/external resorption, or radiolucency in the periapical or furcation regions.
Measured: 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start2 Mar 2023
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological Root Resorption of Primary TeethStudies of the same condition, open and under way.
- 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
- 93 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TUĞBA YİĞİT, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834814
- Sponsor's protocol ID
- ADNANMU1
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physiological Root Resorption in Primary Teeth on the Success of Pulpotomy Treatment: A Prospective, Observational, Two-arm Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT07834814
- Acronym / sponsor ID
- ADNANMU1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 22 Sep 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.
The aim of our study was to evaluate the effect of physiological root resorption on the success of pulpotomy treatment performed using a calcium silicate-based material on primary second molars with deep dentin caries. The study included 93 patients (41 girls, 52 boys) aged 4-11 years with deep dentin caries in their lower primary second molars. Patients were divided into two groups based on the status of physiological root resorption in the primary molar to be treated. The control group (Group 1) consisted of lower second primary molars in which physiological root resorption had not yet begun (n=44), while the study group (Group 2) consisted of lower second primary molars in which physiological root resorption had reached the one-third level of the root (n=49). Patients were called in for follow-up appointments after treatment, and clinical follow-ups were performed at 1, 3, 6, and 12 months, while radiographic follow-ups were conducted at 6 and 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiological root resorption | – | Procedure: Pulpotomy treatment |
| Without physiological root resorption | – | Procedure: Pulpotomy treatment |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Age groups
- Child
- Study population
- Children presenting to the Department of Pediatric Dentistry at Uşak University Faculty of Dentistry for routine examination or treatment.
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 |
|---|---|---|
| Pulpotomy treatmentPulpotomy treatment performed using a calcium silicate-based material | Procedure or surgery | Physiological root resorption, Without physiological root resorption |
Primary outcome
Treatment Success Rate
Time frame: 12 months post-treatment
Clinical Success Criteria: Absence of pain, tenderness, pathological mobility, fistula/abscess, or swelling in the periodontal tissues. Radiographic Success Criteria: Absence of pathological root resorption, internal/external resorption, or radiolucency in the periapical or furcation regions.
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 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Physiological Root Resorption of Primary Teeth, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 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 Turkey (Türkiye). 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?
Treatment Success Rate (time frame: 12 months post-treatment). 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 22 Sep 2026.