Clinical trial NCT05593705: The Prevalence of Variations in Attachment and Morphology of Labial MLF on A Sample of Adult Egyptian Population
Official title: The Prevalence of Variations in Attachment and Morphology of Maxillary Labial Frenum on A Sample of Adult Egyptian Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Labial Tie
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.

Brief summary: The study aims at determining the prevalence of the various types of Maxillary Labial Frenum attachment and morphology among adult Egyptian dental outpatients attending the diagnostic center at Faculty of Dentistry, Cairo University.

Detailed description: A frenum is a fibrous band of tissue attached to the bone of the maxilla and mandible, it is frequently superficial to the muscle attachments. There are different types of frena in a normal oral cavity, most notably the maxillary labial frenum, the mandibular labial frenum, the buccal frenum and the lingual frenum. The primary function of frenum is to provide stability of the upper and lower lip. Labial frenal attachments are thin folds of mucous membrane with enclosed muscle fibers originating from orbicularis oris muscle of the upper lip that attaches at the lips to the alveolar mucosa and underlying periosteum on the middle part of the upper lip between the upper central incisors. The labial frenum has unpredictable variation in reference to size, shape, and position during different time periods of growth and development. During the growth period, it is of less clinical importance as it has the ability to decrease in size. At a younger age frenum is generally wide and thick, with time it becomes thin and small .

Abnormal frenum attachment can lead to distension of the gingival sulcus because of frenal pull causing severe periodontal pockets as there is increase plaque accumulation and gingival recession may be caused by the frenum when attached too closely to the gingival margin. It may even affect denture fit or retention. Abnormal labial frenum has also been associated with various syndromes like Ehlers-Danlos syndrome. There are different types and variations of the labial frenum, for this the frenum assessment during oral examination is important in order to avoid misdiagnosis of normal variations as abnormal frenum.

Eligibility criteria: Inclusion Criteria:

1. Adult Egyptian patients whose age is above 18 years old.
2. Patient consulting in the outpatient clinic
3. Provide informed consent.

Exclusion Criteria:

1. Patients who have had any orofacial anomalies.
2. Trauma/injuries in the premaxillary region.
3. History of prior orthognathic/frenal surgeries.
4. Missing of one or both central incisors.
5. Patient under any medication known to affect the gingiva (e.g., phenytoin).
6. Syndromes associated with different frenal attachments:

   * Ehlers Danlos syndrome.
   * Infantile hypertrophic pyloric stenosis.
   * Holoprosencephaly.
   * Ellis van Creveld syndrome.
   * Oro facial digital syndrome.

Primary outcomes:
measure: Prevalence of variations of maxillary labial frenum attachment
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Morphological labial frenum variations
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Papilla presence
timeFrame: through study completion, an average of 1 year
measure: Gingival Recession Depth (RD)
timeFrame: through study completion, an average of 1 year
measure: Midline diastema
timeFrame: through study completion, an average of 1 year
measure: Width of keratinized gingiva
timeFrame: through study completion, an average of 1 year
measure: Plaque index
timeFrame: through study completion, an average of 1 year
measure: Bleeding on Probing
timeFrame: through study completion, an average of 1 year
Locations:
Study officials:
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