NCT03628742

Brief Summary

Accurate measurement of gingival thickness is crucial for decision making in the field of Periodontology and implant dentistry. Currently implemented techniques for the detection of gingival biotype are of limited reliability. They possess different drawbacks leading to the necessity for the development of a new method to overcome disadvantages of the available techniques. the rational of this study is to determine the accuracy of a specially designed probe in comparison to cone- beam computerized tomography which is accurate enough as found by Fu et al 2010.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Status
unknown

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

June 21, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

June 21, 2018

Last Update Submit

August 13, 2018

Conditions

Gingival ThicknessGingival BiotypePeriodontal Probe

Keywords

periodontal probegingival thicknessgingival biotype

Outcome Measures

Primary Outcomes (1)

  • Special Designed Probe

    Assessment of the diagnostic accuracy of Specially designed probe in measuring the gingival thickness in millimeter unit

    finish the trial in 1 years from the clinical trial registration ( May 2019)

Eligibility Criteria

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

The patient will be selected from the Out Patient Clinic from Oral Medicine and Periodontology Department, Faculty of Dentistry Cairo University.

You may qualify if:

  • In periodontally healthy individuals.
  • Patients with condition indicated for CBCT in upper anterior region
  • Patient age 18-50 years.
  • Intact maxillary central incisors.

You may not qualify if:

  • Pathological lesion in examined site.
  • Any tooth Malalignment in the examined site.
  • Patients using drugs which may induce gingival enlargement.
  • Pregnant females.
  • Any tooth with any metal restoration in the examined site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

June 21, 2018

First Posted

August 14, 2018

Study Start

August 20, 2018

Primary Completion

December 1, 2018

Study Completion

May 1, 2019

Last Updated

August 14, 2018

Record last verified: 2018-08