Prevalence of Non-Carious Cervical Lesions in Patient Wit... | NCT05170529

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

NCT05170529

Sponsor

Cairo University

Status

Completed

Last Update Posted

Sep 1, 2022Actual

Enrollment

362Actual

Phase

Not provided

Conditions

Non-carious Cervical Lesion

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2022Actual

Primary Completion Date

Jun 18, 2022Actual

Completion Date

Jun 20, 2022Actual

First Submitted Date

Dec 7, 2021

First Submission Date that Met QC Criteria

Dec 27, 2021

First Posted Date

Dec 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2022

Last Update Posted Date

Sep 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

362Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of patients with non-carious cervical lesions in Egyptian adult patients with gingival recession	clinical examination	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Oral health related-quality of life (OHR-QoL) OHIP-14 questionnaire	questionnaire	Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo university		Cairo		12613	Egypt