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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05170529
Other study ID # 111021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2022
Est. completion date June 20, 2022

Study information

Verified date August 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 362
Est. completion date June 20, 2022
Est. primary completion date June 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Egypt Cairo university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of patients with non-carious cervical lesions in Egyptian adult patients with gingival recession clinical examination Day 1
Secondary Oral health related-quality of life (OHR-QoL) OHIP-14 questionnaire questionnaire Day 1
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03798184 - Clinical Performance of Prime&Bond Active in Self-etch or Selective-etch Mode With or Without Bioglass N/A
Recruiting NCT05573243 - Clinical Evaluation of Composite Restorations Using Two-steps Universal Adhesive in Non-carious Cervical Lesion (NCCL) N/A