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Tooth Eruption DisorderNCT07587567

Risk Factors for Tooth Eruption Diseases

A study testing PTH1R gene analysis in people with Tooth Eruption Disorder, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Failure of eruption of primary and/or permanent teeth is a rare condition caused by four possible causes. The first is ankylosis of the tooth roots, which, in the absence, even partial, of the alveolar ligament, join the surrounding bone. Read more about this study

Who is it for?
Ages 5 to 80 years
Conditions the study is for
Tooth Eruption Disorder
What is being tested?
PTH1R gene analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
10 Oct 2026to 31 Dec 2030
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 5 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Partial or complete failure of one or more deciduous and/or permanent molar teeth to erupt
  • Diagnostic records (medical history, orthopantomography, clinical photographs)
  • Age between 5 and 80 years
  • Ability to understand and sign consent forms from patients, if adults, or their parents/guardians

Who cannot join

  • Malformative syndromes and/or systemic diseases
  • Lack of diagnostic records
  • Failure of eruption due to traumatic causes

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Cristina Grippaudo, Prof contact

+393334121137

cristina.grippaudo@unicatt.it

About this study

Official title: Determination of Risk Factors for Eruption Disorders in the Primary and Permanent Dentition

Failure of eruption of primary and/or permanent teeth is a rare condition caused by four possible causes. The first is ankylosis of the tooth roots, which, in the absence, even partial, of the alveolar ligament, join the surrounding bone. The second possible cause is failure of eruption due to mechanical impediment, in the presence of a cyst or lack of resorption of the bone overlying the developing tooth, or due to severe lack of space or an abnormal inclination of the tooth's eruption path. The third cause, called Primary Failure of Eruption (PFE), is genetic in nature due to insufficient production of the factors that determine tooth eruption. In this case, molars are the most affected teeth, and pathogenic variants of the PTH1R gene are often observed. The fourth possibility is delayed tooth eruption. In cases of ankylosis and PFE, orthodontic treatments to help recover the teeth in the arch may fail.

This interventional study, comprising a retrospective cohort, aims to evaluate the clinical signs of dental eruption disorders to identify criteria to facilitate clinical diagnosis. Furthermore, in cases where PFE is suspected, diagnostic testing for the PTH1R gene will be performed.

Read more

The study will be conducted at the Fondazione Policlinico Universitario "A. Gemelli" IRCCS in Rome and will enroll 50 consecutive patients with dental eruption disorders of deciduous and/or permanent molars. The primary outcome will be to strengthen the differential diagnostic hypothesis. The study will also examine the phenotype/genotype correlation in patients tested for PTH1R gene variants. The characteristics of the sample will be compared with those of the sample enrolled in the previous study (C.E. UCSC ID 565-11/2015), which will be examined retrospectively. Extending the analysis to the patient cohort enrolled since 2015 is particularly valuable given the rarity of the diseases under study and the resulting small number of cases available for research.

The study results will provide new data on pathogenic variants of PTH1R and on the phenotype/genotype correlation of the various diseases characterized by tooth eruption disorder. They will also help identify more sustainable and effective clinical strategies.

Read the detailed description

Tooth eruption is characterized by the movement of the developing tooth from its origin in the bone to its functional position in the oral cavity . In the mouse model, the eruption process is orchestrated by stem cells surrounding the tooth and the periodontal ligament (PDL). The development of the PDL is determined by the expression of Pth1r, a protein-coding gene encoding the parathyroid hormone receptor . During this process, eruption failure may occur, which could be diagnosed as primary failure of eruption (PFE; OMIM # 125350) or ankylosis. In the case of PFE, loss of Pth1r function within Pthrp-expressing cells affects the PDL and root phenotype, resulting in eruption failure . This condition is most evident in the first permanent molars, and the eruption phenotype is partially penetrant. The eruption path is unobstructed because parathyroid hormone-related protein (PTHLH; OMIM168470) is normally expressed in coronal dental epithelial cells, whereas it is deficient in mesenchymal cells surrounding the roots. In humans with pathogenic variants of parathyroid hormone receptor 1 (PTH1R, OMIM168468), the eruption path is unobstructed, but eruption ceases and the affected tooth partially erupts. Orthodontic forces may be futile to move the affected teeth. PTH1R is a receptor for both parathyroid hormone (PTH; OMIM 168450) and parathyroid hormone-related protein (PTHLH). Previous studies described the involvement of the PTH1R gene in 2010 ; Previously published studies generally refer to "unexplained cessation of eruption" or a "poorly understood condition" , observing clinical signs more representative of PFE. In cases with a high probability of PFE, it is useful to search for variants of the PTH1R gene. Since genetic testing is not accessible to some, determining whether there is a family history represents a valid alternative.

In the case of ankylosis, the distinctive differential diagnosis is fusion of the tooth root surface with the surrounding bone. The pathogenesis of ankylosis is less well understood but has been associated with a history of trauma ; the presence of residual Malassez epithelial cells has been found to be essential for preventing fusion between the alveolar bone and the tooth. Overexpression of WNT is responsible for cementum overgrowth and ankylosis . Regardless of this distinctive histological feature, definitive diagnosis of ankylosis is difficult and often nearly impossible. In practice, the diagnosis of ankyloses relies more on the exclusion of other causes of eruption failure and the clinical context (i.e., usually isolated). Non-eruption of permanent molars is the rarest impaction of permanent teeth . This finding is always challenging for the dentist, even more so when it affects a child. From a clinical point of view, it is very difficult to distinguish between PFE and ankyloses during an early diagnosis process. In both cases, the affected teeth either fail to erupt or occupy an infra-occluded position. Ankylosed teeth should elicit a high-pitched metallic sound upon percussion and have little or no mobility . However, relying on differences in percussive sounds elicited by percussion with an instrument can vary greatly from operator to operator and may not be reproducible. In contrast, the use of an Osstell Mentor (Osstell, Gothenburg, Sweden) that detects resonance frequency analysis, as used in implantology, offers some promise . In PFE, the affected teeth are normally mobile but become ankylotic in response to orthodontic force. If ankylosis is suspected, panoramic radiography does not clearly and definitively demonstrate the absence of the periodontal ligament, especially in multirooted teeth. As demonstrated by Raghoebar et al. , the areas of ankylosis are small and often located between the roots.

Early diagnosis is based on the clinical observation of delayed first molar eruption and on signs detected on panoramic radiography of the dental arches. Unfortunately, differential diagnosis is very difficult. During childhood, the causes of Mechanical Failure of Eruption (MFE) are easier to identify, mainly due to lack of space in the arch or the presence of cysts or supernumerary teeth that prevent eruption. Another possible cause of the absence of the first permanent molars in the arch is delayed eruption, which alters the timing of occlusion development, but not the eruption mechanism ].

Failure to erupt in permanent first molars is a rare event [Roulias et al., 2022], but it presents clinicians with two significant challenges. First, the correct diagnostic classification can be difficult to confirm, and second, the resulting treatment options are often limited and yield suboptimal outcomes. Among the professionals who may first discover an eruption disorder in a child (e.g., general practitioners and pediatric dentists), neither may choose to provide therapeutic management for this malocclusion, as it often falls within the scope of work most often performed by an orthodontist. However, when this problem is observed in a child, if the practitioner fails to make a timely and correct diagnosis and treatment, the prognosis is poor. This means that the affected tooth or teeth fail to erupt, their position within the jaws worsens, and more or less severe alterations in occlusal relationships are observed. Tongue function is also affected, and the patient's face may develop asymmetry.

With this study, we aim to refine the identification of the distinctive clinical features of ankylosis, MFE, PFE, and delayed tooth eruption. We also aim to broaden and deepen our understanding of the pathogenic variants of PTH1R related to PFE.

HYPOTHESIS The clinical signs associated with dental eruption failure may have a different prevalence and severity in relation to ankylosis, MFE, PFE, and delayed tooth eruption. Furthermore, the identification of new pathogenic variants of PTH1R related to PFE could help clarify the genetic mechanisms underlying primary eruption failure.

Being tested
PTH1R gene analysis
Keywords
primary failure of dental eruption, Dental ankylosis, mechanical failure of dental eruption, PTH1R gene
Medical subject headings
Tooth Ankylosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PTH1R gene analysisDiagnostic test

    Diagnostic records will be reviewed and clinical signs related to the eruption defect will be identified and classified.

    DNA samples will be collected using three cytobrushes (Cooper Surgical, Trumbull, CT, USA) and extracted with the QIAamp DNA mini kit (part number 51304, Qiagen). Amplification and nucleotide sequencing of the intronic/exonic regions of the PTH1R gene (NM_000316.3) will be performed as described in Grippaudo et al. (2021). All sequences will be aligned to the reference genome (GRCh38/hg38), and the frequency of variants in the general population will be verified against the Genome Aggregation Database (GnomAD) (https://gnomad.broadinstitute.org/) and the Single Nucleotide Polymorphism Database (dbSNP) (https://www.ncbi.nlm.nih.gov/snp/). The potential pathogenicity of the identified variants will be searched in the NCBI ClinVar database (https://www.ncbi.nlm.nih.gov/clinvar/).

    The data will be collected using a password-protected Excel file.

Study groups in NCT07587567
Study groupRoleWhat they receive
Patients with eruption disordersOtherPatients with eruption disorders of deciduous and/or permanent molars
Receives: Diagnostic Test: PTH1R gene analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of delayed tooth eruption

    Differential diagnosis between ankylosis, MFE, PFE and delayed tooth eruption based on the presence and frequency of clinical signs and PTH1R gene variants.

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start10 Oct 2026 (estimated)
  3. Primary completion10 Jun 2029 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07587567
Sponsor's protocol ID
27111-1
Status last verified
May 2026
First submitted
8 May 2026
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Roulias P, Kalantzis N, Doukaki D, Pachiou A, Karamesinis K, Damanakis G, Gizani S, Tsolakis AI. Teeth Eruption Disorders: A Critical Review. Children (Basel). 2022 May 24;9(6):771. doi: 10.3390/children9060771.

    PubMed 35740708
  • Suri L, Gagari E, Vastardis H. Delayed tooth eruption: pathogenesis, diagnosis, and treatment. A literature review. Am J Orthod Dentofacial Orthop. 2004 Oct;126(4):432-45. doi: 10.1016/j.ajodo.2003.10.031.

    PubMed 15470346
  • Raghoebar GM, Jansen HW, Jongebloed WL, Boering G, Vissink A. Secondary retention of permanent molars: an assessment of ankylosis by scanning electron and light microscopy. Br J Oral Maxillofac Surg. 1992 Feb;30(1):50-5. doi: 10.1016/0266-4356(92)90137-8.

    PubMed 1550806
  • Raghoebar GM, Boering G, Jansen HW, Vissink A. Secondary retention of permanent molars: a histologic study. J Oral Pathol Med. 1989 Sep;18(8):427-31. doi: 10.1111/j.1600-0714.1989.tb01338.x.

    PubMed 2691646
  • Bertl MH, Weinberger T, Schwarz K, Gruber R, Crismani AG. Resonance frequency analysis: a new diagnostic tool for dental ankylosis. Eur J Oral Sci. 2012 Jun;120(3):255-8. doi: 10.1111/j.1600-0722.2012.00959.x. Epub 2012 Apr 21.

    PubMed 22607343
  • Mubeen S, Seehra J. Failure of eruption of first permanent molar teeth: a diagnostic challenge. J Orthod. 2018 Jun;45(2):129-134. doi: 10.1080/14653125.2018.1462902. Epub 2018 Apr 16.

    PubMed 29659339
  • Raghoebar GM, Boering G, Vissink A. Clinical, radiographic and histological characteristics of secondary retention of permanent molars. J Dent. 1991 Jun;19(3):164-70. doi: 10.1016/0300-5712(91)90007-l.

    PubMed 1939817
  • Wu Y, Yuan X, Perez KC, Hyman S, Wang L, Pellegrini G, Salmon B, Bellido T, Helms JA. Aberrantly elevated Wnt signaling is responsible for cementum overgrowth and dental ankylosis. Bone. 2019 May;122:176-183. doi: 10.1016/j.bone.2018.10.023. Epub 2018 Oct 25.

    PubMed 30408613
  • Islam ST, Kurashige Y, Minowa E, Yoshida K, Paudel D, Uehara O, Okada Y, Bolortsetseg D, Sakakibara S, Abiko Y, Saitoh M. Analysis of the cells isolated from epithelial cell rests of Malassez through single-cell limiting dilution. Sci Rep. 2022 Jan 10;12(1):382. doi: 10.1038/s41598-021-04091-0.

    PubMed 35013397
  • Dogramaci E, Rossi-Fedele G. Infraposition or infraocclusion- Is it time to rename? Dent Traumatol. 2021 Dec;37(6):813-814. doi: 10.1111/edt.12711. Epub 2021 Sep 19.

    PubMed 34538004
  • Grippaudo C, D'Apolito I, Cafiero C, Re A, Chiurazzi P, Frazier-Bowers SA. Validating clinical characteristic of primary failure of eruption (PFE) associated with PTH1R variants. Prog Orthod. 2021 Dec 13;22(1):43. doi: 10.1186/s40510-021-00387-z.

    PubMed 34897565
  • Frazier-Bowers SA, Koehler KE, Ackerman JL, Proffit WR. Primary failure of eruption: further characterization of a rare eruption disorder. Am J Orthod Dentofacial Orthop. 2007 May;131(5):578.e1-11. doi: 10.1016/j.ajodo.2006.09.038.

    PubMed 17482073
  • Ahmad S, Bister D, Cobourne MT. The clinical features and aetiological basis of primary eruption failure. Eur J Orthod. 2006 Dec;28(6):535-40. doi: 10.1093/ejo/cjl033. Epub 2006 Oct 13.

    PubMed 17041084
  • Frazier-Bowers SA, Simmons D, Wright JT, Proffit WR, Ackerman JL. Primary failure of eruption and PTH1R: the importance of a genetic diagnosis for orthodontic treatment planning. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):160.e1-7; discussion 160-1. doi: 10.1016/j.ajodo.2009.10.019.

    PubMed 20152661
  • Stellzig-Eisenhauer A, Decker E, Meyer-Marcotty P, Rau C, Fiebig BS, Kress W, Saar K, Ruschendorf F, Hubner N, Grimm T, Witt E, Weber BH. Primary failure of eruption (PFE)--clinical and molecular genetics analysis. J Orofac Orthop. 2010 Jan;71(1):6-16. doi: 10.1007/s00056-010-0908-9. Epub 2010 Feb 5. English, German.

    PubMed 20135246

Questions about this trial

What is this clinical trial studying?

A study testing PTH1R gene analysis in people with Tooth Eruption Disorder, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

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 4 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: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Cristina Grippaudo, Prof (+393334121137, cristina.grippaudo@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of delayed tooth eruption (time frame: 60 months). 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 NCT07587567, which also lists 19 linked publications.

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 4 Sep 2026.

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