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Risk Factors for Tooth Eruption Diseases

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.

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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

介入

入学 (推定)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:診断
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
他の:Patients with eruption disorders
Patients with eruption disorders of deciduous and/or permanent molars

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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Evaluation of delayed tooth eruption
時間枠:60 months
Differential diagnosis between ankylosis, MFE, PFE and delayed tooth eruption based on the presence and frequency of clinical signs and PTH1R gene variants.
60 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:cristina Grippaudo、Fondazione Policlinico Universitario Agostino Gemelli IRCCS

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月10日

一次修了 (推定)

2029年6月10日

研究の完了 (推定)

2030年12月31日

試験登録日

最初に提出

2026年5月8日

QC基準を満たした最初の提出物

2026年5月8日

最初の投稿 (実際)

2026年5月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月4日

QC基準を満たした最後の更新が送信されました

2026年9月2日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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