NCT05170529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

December 7, 2021

Last Update Submit

August 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of patients with non-carious cervical lesions in Egyptian adult patients with gingival recession

    clinical examination

    Day 1

Secondary Outcomes (1)

  • Oral health related-quality of life (OHR-QoL) OHIP-14 questionnaire

    Day 1

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, 12613, Egypt

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

December 7, 2021

First Posted

December 28, 2021

Study Start

January 10, 2022

Primary Completion

June 18, 2022

Study Completion

June 20, 2022

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations