The Prevalence of Variations in Attachment and Morphology of Labial MLF on A Sample of Adult Egyptian Population

Not yet recruiting

• Conditions: Labial Tie

• Registration Number: NCT05593705
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-09
• Study First Submitted QC: 2022-10-23
• Study First Posted: 2022-10-25
• Last Update Submitted: 2022-10-30
• Last Update Posted: 2022-11-01
• Study Start: 2022-11-10
• Primary Completion: 2023-01
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 384

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of variations of maxillary labial frenum attachment	through study completion, an average of 1 year	The primary outcome of the study is the prevalence of variations of maxillary labial frenum attachment. It will be diagnosed by proper history and clinical examination.; The clinical examination will be performed, patients will be examine lying in a supine position using direct visual method on the dental unit. Under adequate light the upper lip will gently lift with the index finger and thumb of both hands. The site of attachment of frenum will be examined through direct visual examination and intraoral photographs will be also taken. The clinical classification of maxillary frenum insertion by (Mirko, Miroslav and Lubor, 1974)

Secondary Outcome Measures

Name	Time	Method
Morphological labial frenum variations	through study completion, an average of 1 year	Under adequate light the upper lip will gently lift with the index finger and thumb of both hands. The morphology of frenum will be examined through direct visual examination and intraoral photographs will be also taken. The classification of the frenum variations in morphology are eight different types, simple, persistent tectolabial, simple with appendix, simple with nodule, double frenum, frenum with nichum, bifid frenum and frenum with one or more variation of the above (Sewerin, 1971)