Non-carious Cervical LesionNCT05170529

Prevalence of Non-Carious Cervical Lesions in Patient With Gingival Recession and Associated Risk Factors

An observational study of Non-carious Cervical Lesion, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for: Non-carious Cervical Lesion
How many people: 362 participants
Where: 1 siteEgypt
Study dates: 10 Jan 2022to 20 Jun 2022
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 15 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: adult Egyptian patients with gingival recession attending the dental diagnostic centre in Cairo university

Who may be able to join

adult patients with NCCL and gingival recession whose age is above 15 years old
patients consulting in dental Diagnostic Centre, faculty of dentistry, Cairo University
patients provide informed consent

Who cannot join

patients having problem in mouth opening or undergoing intermaxillary fixation where oral examination is not possible
patients diagnosed with psychiatric problems

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Cairo university
Cairo, 12613

Other trials in Egypt

About this study

Official title: Prevalence of Non-Carious Cervical Lesions in Patient With Gingival Recession and Associated Risk Factors: A Hospital Based Cross-Sectional Study in a Sample of Adult Egyptian Dental Patients.

The study aims at determining the prevalence of non carious cervical lesions in patients with gingival recession in Egyptian population and associated risk factors including gingival biotype, keratinized tissue width, gingival index, plaque index, occlusal wear grade, sensitivity. and a questionnaire will be filled by patients with another risk factors including age, gender, toothbrush frequency and type, bruxism, gastric reflux, soft drinks, alcohol and citrus fruits. Also OHIP-14 will be answered in a questionnaire form by patients.

Read the detailed description

Dental patients will be recruited in a consecutive manner from diagnostic centre at Cairo University Dentistry faculty. Patients with NCCL will be selected for questionnaires and clinical examination. Thorough oral examination will be done, the full aim of the study will be explained to the patient, and patient acceptance is a must. The questionnaire will be done with face to face interview with the patient will include associated risk factors including gingival biotype, keratinized tissue width, gingival index, plaque index, occlusal wear grade, sensitivity. and a questionnaire will be filled by patients with another risk factors including age, gender, toothbrush frequency and type, bruxism, gastric reflux, soft drinks, alcohol and citrus fruits. Also OHIP-14 will be answered in a questionnaire form by patients including: functional limitations, physical pain, psychological discomfort, physical disability, psychological disability, social disability, handicap. then clinical examination will be done for NCCL using mirror, probe, light of the unit, air tip.

Conditions: Non-carious Cervical Lesion

What is being measured

The primary outcome is the main question the study is designed to answer.

number of patients with non-carious cervical lesions in Egyptian adult patients with gingival recession
clinical examination
Measured: Day 1

Secondary outcomes (1)

Oral health related-quality of life (OHR-QoL) OHIP-14 questionnaire
questionnaire
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 202220 Jun 2022

First posted28 Dec 2021
Study start10 Jan 2022
Primary completion18 Jun 2022
Study completion20 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-carious Cervical LesionStudies 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: Other
Time perspective: Cross-sectional
Enrolment: 362 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05170529
Sponsor's protocol ID: 111021
Status last verified: Aug 2022
First submitted: 7 Dec 2021
Last updated: 1 Sep 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Two Year Clinical Performance of Ion-releasing and Non Ion-releasing Composite Restorative Systems in Restoring Cervical Carious Lesions.
Class V Dental Caries
Recruiting
Root Coverage Performance of Restorative Materials in Class V Cavities
Gingival Recession, Non-Carious Cervical Lesions (NCCLs)
Active, not recruiting
Different Modes of Universal Adhesive in Smokers and Non-Smokers
Healthy Participant
Not yet recruiting
Evaluation of Different Non-Invasive Methods in the Treatment of Dentin Hypersensitivity Associated With Non-Carious Cervical Lesions: A Split-Mouth Clinical Study
Non-Carious Cervical Lesions (NCCLs), Dentin Hypersensitivity
Active, not recruiting
Evaluating Universal Adhesives in Cervical Lesions
Cervical Lesion, Dental

All Non-carious Cervical Lesion trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevalence of Non-Carious Cervical Lesions in Patient With Gingival Recession and Associated Risk Factors: A Hospital Based Cross-Sectional Study in a Sample of Adult Egyptian Dental Patients.
ClinicalTrials.gov ID: NCT05170529
Acronym / sponsor ID: 111021
Conditions: Non-carious Cervical Lesion
Study type: Observational
Recruitment status: Completed
Enrolment: 362 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: 10 Jan 2022 (actual)
Primary completion: 18 Jun 2022 (actual)
Study completion: 20 Jun 2022 (actual)
First posted: 28 Dec 2021 (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.

Detailed description

Study design

Observational model: Other
Time perspective: Cross-sectional

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: adult Egyptian patients with gingival recession attending the dental diagnostic centre in Cairo university

Key inclusion criteria (3 listed)

adult patients with NCCL and gingival recession whose age is above 15 years old
patients consulting in dental Diagnostic Centre, faculty of dentistry, Cairo University
patients provide informed consent

Key exclusion criteria (2 listed)

patients having problem in mouth opening or undergoing intermaxillary fixation where oral examination is not possible
patients diagnosed with psychiatric problems

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

number of patients with non-carious cervical lesions in Egyptian adult patients with gingival recession
Time frame: Day 1
clinical examination

1 secondary outcome

Oral health related-quality of life (OHR-QoL) OHIP-14 questionnaire
Time frame: Day 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.

Related trials for Non-carious Cervical Lesion

Active, not recruiting
Two Year Clinical Performance of Ion-releasing and Non Ion-releasing Composite Restorative Systems in Restoring Cervical Carious Lesions.
Class V Dental Caries
Recruiting
Root Coverage Performance of Restorative Materials in Class V Cavities
Gingival Recession, Non-Carious Cervical Lesions (NCCLs)
Active, not recruiting
Different Modes of Universal Adhesive in Smokers and Non-Smokers
Healthy Participant
Not yet recruiting
Evaluation of Different Non-Invasive Methods in the Treatment of Dentin Hypersensitivity Associated With Non-Carious Cervical Lesions: A Split-Mouth Clinical Study
Non-Carious Cervical Lesions (NCCLs), Dentin Hypersensitivity
Active, not recruiting
Evaluating Universal Adhesives in Cervical Lesions
Cervical Lesion, Dental

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-carious Cervical Lesion, run by Cairo University at 1 site in Egypt.

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 2 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: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of patients with non-carious cervical lesions in Egyptian adult patients with gingival recession (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05170529.

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 Sep 2022.