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

NCT05593705 | Unknown

• 1 other identifier: variations in MLF
• Study Type: observational
• Target: 384
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Labial Tie

Outcome Measures

Primary Outcomes (1)

• Prevalence of variations of maxillary labial frenum attachment

  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)

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Morphological labial frenum variations

  through study completion, an average of 1 year

Other Outcomes (6)

• Papilla presence

  through study completion, an average of 1 year

• Gingival Recession Depth (RD)

  through study completion, an average of 1 year

• Midline diastema

  through study completion, an average of 1 year

Interventions

observation OTHER

photograph for maxillary labial frenum and measurements with a periodontal probe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who have had any orofacial anomalies.
• Trauma/injuries in the premaxillary region.
• History of prior orthognathic/frenal surgeries.
• Missing of one or both central incisors.
• Patient under any medication known to affect the gingiva (e.g., phenytoin).
• Syndromes associated with different frenal attachments:
• Ehlers Danlos syndrome.
• Infantile hypertrophic pyloric stenosis.
• Holoprosencephaly.
• Ellis van Creveld syndrome.
• Oro facial digital syndrome.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Abeer A ALFakih, master

CONTACT

00201156544633; abeer.hussien@dentistry.cu.edu.eg

Weam A EL Battawy, ass.prof

CONTACT

weamelbattawy@dentistry.cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: October 25, 2022
• Study Start: November 10, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2023
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share