Labial TieNCT05593705
The Prevalence of Variations in Attachment and Morphology of Labial MLF on A Sample of Adult Egyptian Population
An observational study of Labial Tie, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Labial Tie
- What is being tested?
- observation
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2022to Feb 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
Who may be able to join
- Adult Egyptian patients whose age is above 18 years old.
- Patient consulting in the outpatient clinic
- Provide informed consent.
Who cannot join
- 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:
Show all 11Show fewer
- Ehlers Danlos syndrome.
- Infantile hypertrophic pyloric stenosis.
- Holoprosencephaly.
- Ellis van Creveld syndrome.
- Oro facial digital syndrome.
Trial locations and contacts
No sites are listed yet.
Weam A EL Battawy, ass.prof contact
About this study
Official title: The Prevalence of Variations in Attachment and Morphology of Maxillary Labial Frenum on A Sample of Adult Egyptian Population
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.
Read the 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.
- Conditions
- Labial Tie
- Being tested
- observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
photograph for maxillary labial frenum and measurements with a periodontal probe
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Morphological labial frenum variations
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)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start10 Nov 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labial TieStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 384 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ali Hussein Al-Fkih, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593705
- Sponsor's protocol ID
- variations in MLF
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Variations in Attachment and Morphology of Maxillary Labial Frenum on A Sample of Adult Egyptian Population
- ClinicalTrials.gov ID
- NCT05593705
- Acronym / sponsor ID
- variations in MLF
- Conditions
- Labial Tie
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
Key inclusion criteria (3 listed)
- Adult Egyptian patients whose age is above 18 years old.
- Patient consulting in the outpatient clinic
- Provide informed consent.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationphotograph for maxillary labial frenum and measurements with a periodontal probe | Other | – |
Primary outcome
Prevalence of variations of maxillary labial frenum attachment
Time frame: 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)
1 secondary outcome
Morphological labial frenum variations
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weam A EL Battawy, ass.prof contact
Questions about this trial
What is this clinical trial studying?
An observational study of Labial Tie, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abeer A ALFakih, master (00201156544633, abeer.hussien@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of variations of maxillary labial frenum attachment (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.