An observational study in Ankyloglossia, sponsored by Istanbul Health and Technology University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Istanbul Health and Technology University · Observational
This study aimed to evaluate the impact of lingual frenulum morphology on orofacial myofunctional functions in children during the mixed dentition period.
Orofacial myofunctional disorders are known to affect essential functions such as swallowing, breathing, and resting tongue posture, especially in growing children. Variations in lingual frenulum anatomy may contribute to such dysfunctions and influence orofacial development.
32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.
Browse Ankyloglossia studies →Istanbul Health and Technology University is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Healthy children aged 7-12 years with fully erupted permanent maxillary central incisors and the ability to cooperate during clinical oral and speech evaluations. Children undergoing orthodontic treatment or presenting with cleft lip/palate, delayed incisor eruption, or speech impairments were excluded.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tongue Range of Motion Ratio (TRMR, %)
TRMR (%) is calculated by dividing the interincisal distance with the tongue tip on the incisive papilla by the maximum mouth opening, multiplied by 100. Both distances are measured in millimeters using a digital caliper and averaged over three repetitions.
Time frame: Baseline (single study visit)
Diagnosis of Ankyloglossia Based on the Marchesan Protocol
Ankyloglossia was assessed using the standardized lingual frenulum evaluation protocol developed by Irene Marchesan (Marchesan, 2012). The protocol includes anatomical and functional observations and yields a diagnostic score. Participants were classified as having ankyloglossia or not based on the cut-off values defined in the protocol.
Time frame: Baseline (single study visit)
Mentalis Muscle Activity
Mentalis muscle activity during swallowing was assessed through clinical observation and manual palpation, following the Orofacial Myofunctional Evaluation with Scores (OMES) protocol.
Time frame: Baseline (single study visit)
Swallowing Pattern
Swallowing pattern was evaluated through observation of tongue posture following the Orofacial Myofunctional Evaluation with Scores (OMES) protocol
Time frame: Baseline (single study visit)
Breathing Pattern
Breathing pattern was classified based on clinical observation of habitual respiratory behavior at rest. Participants were categorized as having nasal, oral, or mixed breathing following the Orofacial Myofunctional Evaluation with Scores (OMES) protocol
Time frame: Baseline (single study visit)
Ran from May 2024 to primary completion in Oct 2024, 5 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Istanbul Health and Technology University