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Congenital CataractNCT06950619

Associations Between Dental Anomalies and Ocular, Cutaneous and Skin Appendages Features

A study testing Whole Genome Sequencing and Cephalometric tracing in people with Congenital Cataract and Tooth Abnormalities, run by University of Pavia at 2 sites in Italy.

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

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Trial summary

Considering recent literature, it is possible to hypothesise a link between dental anomalies and ocular and/or cutaneous findings, given the existence of shared genetic and developmental mechanisms between these two anatomical areas. Read more about this study

Who is it for?
Ages 12 to 70 years
What is being tested?
Whole Genome Sequencing and Cephalometric tracing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
2 sitesItaly
Study dates
Feb 2026to Apr 2027
Phase
Interventional

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 12 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Supernumerary teeth
  • oligodontia
  • screw driver sharped incisors
  • Hutchinson's teeth
  • mulberry molars
  • tooth agenesis
  • congenital cataract, keratitis, keratoconus, corneal dystrophies, ectopia lentis, glaucoma, retinitis pigmentosa, coloboma and aniridia in probands or relatives
  • skin appendages anomalies in probands or relatives

Who cannot join

  • Previous orthodontic, restorative, endodontic, prosthetic and surgical treatment that could alter tooth morphology and position

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Italy2 sites
  • Unit of Medical Genetics, Department of Molecular Medicine, University of Pavia

    Pavia, Lombardy, 27100

    Edoardo Errichiello, PhD, edoardo.errichiello@unipv.it

  • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

    Pavia, Lombardy, 27100

    Maurizio Pascadopoli, PhD, +39 0382516223, maurizio.pascadopoli01@universitadipavia.it

Other trials in Italy

About this study

Official title: A Clinical Investigation Into the Co-occurrence of Dental Anomalies With Ocular and Cutaneous Features

Considering recent literature, it is possible to hypothesise a link between dental anomalies and ocular and/or cutaneous findings, given the existence of shared genetic and developmental mechanisms between these two anatomical areas. Both the eye and teeth develop from ectodermal and mesenchymal tissues, involving common molecular signalling pathways such as Wnt, BMP and PAX. Genetic variants affecting these pathways can therefore determine combined phenotypes, such as congenital cataracts associated with dental agenesis or enamel malformations. Some rare genetic syndromes, such as Nance-Horan syndrome and oculofacio-cardio-dental (OFCD) syndrome, support the hypothesis of a systemic correlation between odontogenesis and ocular development. In a previous study on congenital cataracts, nearly 10% of probands with variants in the BCOR, CWC27, IFIH1, NHS, and PAX6 genes had various dental abnormalities. Therefore, exploring the possible connection between eye and dental diseases may not only facilitate early and multidisciplinary diagnosis, but also open up new perspectives in genetic research and the development of personalised therapeutic approaches, for which whole genome sequencing (WGS) appears to be the first choice for investigating non-syndromic forms. Therefore, the current clinical study aims to identify variants in genes common to eye diseases and dental anomalies (agenesis, supernumerary teeth, Hutchinson's teeth, mulberry molars) in orthodontic patients over the age of 12 with dental anomalies who are about to begin orthodontic treatment or who are attending routine check-ups at the Orthodontics and Paediatric Dentistry Unit, Department of Clinical, Surgical, Diagnostic and Paediatrics Sciences at the University of Pavia who have a family history of ocular and cutaneous manifestations or presenting at the same time dental, ocular and/or cutaneous anomalies. Patients who are eligible will be invited to participate in the study. After signing the informed consent form, the Case Report Form will be completed to collect the data of interest for the study; previous medical reports will be asked to patients or parents/legal guardians in case of minors to ascertain ocular and cutaneous pathologies; a buccal swab will be taken to collect a DNA sample that will be analysed with Next Generation Sequencing. In addition, cephalometric evaluations will be performed if lateral teleradiographs will be available, if already performed in accordance with Good Clinical Practice for the purposes of orthodontic assessment of patients.

Being tested
Whole Genome Sequencing, Cephalometric tracing
Medical subject headings
Tooth Abnormalities

What participants receive

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

  • Whole Genome SequencingGenetic

    Genetic testing will be performed to find variants in genes involving congenital cataract and/or ocular diseases (keratitis, keratoconus, corneal dystrophies, ectopia lentis, glaucoma, retinitis pigmentosa, coloboma and aniridia) and dental anomalies (tooth agenesis, supernumerary teeth, Hutchinson teeth, mulberry molars). Cutaneous appendage anomalies will be also evaluated in clinical history for ascertaining ectodermal diplasia.

  • Cephalometric tracingOther

    Cephalometric tracing will be performed on lateral cephalometric radiographs if present and not taken on purpose for the study

Study groups in NCT06950619
Study groupRoleWhat they receive
Orthodontic patientsExperimentalPatients fulfilling the inclusion criteria will undergo blood sampling
Receives: Genetic: Whole Genome Sequencing; Other: Cephalometric tracing

What is being measured

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

  1. Presence of variants in common genes for dental anomalies, ocular diseases and cutaneous/skin appendages features

    Whole Genome Sequencing will be used to find pathogenetic variants

    Measured: Baseline

Secondary outcomes (9)
  1. SNA angle

    Angle between the sella, nasion and A point measured on lateral cephalometric radiograph

    Measured: Baseline

  2. SNB angle

    Angle between the sella, nasion and B point measured on lateral cephalometric radiograph

    Measured: Baseline

  3. ANB angle

    Angle between point A, the nasion and point B measured on lateral cephalometric radiograph

    Measured: Baseline

  4. SN plane

    Plane between the sella point S and nasion point N measured on lateral cephalometric radiograph

    Measured: Baseline

  5. ANS-PNS plane

    Bispinal plane traced between the anterior nasal spine (ANS) and the posterior nasal spine (PNS) measured on lateral cephalometric radiograph

    Measured: Baseline

  6. GoGn plane

    Mandibular plane traced between Gonion and Gnathion points measured on lateral cephalometric radiograph

    Measured: Baseline

  7. Sella turcica length

    Distance between the Tuberculum sellae (TS) and the dorsum sella measured on lateral cephalometric radiograph

    Measured: Baseline

  8. Sella turcica diameter

    Distance between the Tuberculum Sellae (TS) and the farthest point on the inner wall of the sella measured on lateral cephalometric radiograph

    Measured: Baseline

  9. Sella turcica depth

    The distance of a line dropped perpendicularly from the interclinoidal distance to the deepest point of the sella floor measured on lateral cephalometric radiograph

    Measured: Baseline

Timeline

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

  1. First posted30 Apr 2025
  2. Study startFeb 2026 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (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
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06950619
Sponsor's protocol ID
2025-DENTALOCULARANOMALIES
Status last verified
Nov 2025
First submitted
21 Apr 2025
Last updated
19 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be available upon motivated request to the Principal Investigator.

Publications

  • Lecca M, Mauri L, Gana S, Del Longo A, Morelli F, Nicotra R, Plumari M, Galli J, Sirchia F, Valente EM, Cavallari U, Mazza M, Signorini S, Errichiello E. Novel molecular, structural and clinical findings in an Italian cohort of congenital cataract. Clin Genet. 2024 Oct;106(4):403-412. doi: 10.1111/cge.14568. Epub 2024 Jun 5.

    PubMed 38840272

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