Impact of Lingual Frenulum Variations on Orofacial Growth in Children
NCT07924163, Completed, Istanbul Health and Technology University
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Impact of Lingual Frenulum Variations on Orofacial Growth in Children | ClinicalTrials.gov |
| NCT number | NCT07924163 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 170 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Istanbul Health and Technology University | ClinicalTrials.gov |
| Conditions | Ankyloglossia | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Tongue Range of Motion Ratio (TRMR, %) | Baseline (single study visit) | 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. | ClinicalTrials.gov |
| Primary | Diagnosis of Ankyloglossia Based on the Marchesan Protocol | Baseline (single study visit) | 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. | ClinicalTrials.gov |
| Secondary | Mentalis Muscle Activity | Baseline (single study visit) | Mentalis muscle activity during swallowing was assessed through clinical observation and manual palpation, following the Orofacial Myofunctional Evaluation with Scores (OMES) protocol. | ClinicalTrials.gov |
| Secondary | Swallowing Pattern | Baseline (single study visit) | Swallowing pattern was evaluated through observation of tongue posture following the Orofacial Myofunctional Evaluation with Scores (OMES) protocol | ClinicalTrials.gov |
| Secondary | Breathing Pattern | Baseline (single study visit) | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)