Evaluation of Intraoral Ultrasonography Accuracy Compared to Gold Standard Method in Gingival Thickness Assessment on Candidates for Crown Lengthening Surgery
Main Objective : Comparison between ultrasonography and gold standard method in gingival thickness measurement on patients scheduled for crown lengthening.
Design
Study type : Diagnostic clinical trial
Gingival thickness will be measured in 34 patients ( male & female), and in every patient 40 sites will be measured at the midbuccal of all anterior and premolar teeth in both upper and lower jaw (in each tooth, two sites in 2 & 4 millimeters from free gingival level).
Settings and conduct
All measurements will take place at a private radiologic practice.
An ultrasonography (E-CUBE 7,ALPINION) intraoral probe (2 Cm length,12 MHz) will be used to measure thickness on specified locations.
The probe will be placed vertically on both tooth and gingiva; measured values will be recorded.
2% lidocaine infiltration will be done and using a size 25 endodontic spreader (Mani, 25 mm,2% convergence) the same sites will be measured as so :
The spreader will be inserted in soft tissue until it contacts the hard tissue and then the rubber will be placed on the gingival surface , the inserted length will be measured with a digital caliper. Recorded values will be compared and analyzed.
Participants/Inclusion and exclusion criteria
Patients scheduled for crown lengthening with healthy periodontium.
Patients with inflamed gingiva or pregnant Patients or those who take any medication that would cause gingival hyperplasia will be excluded from the study due to measurement bias.
Intervention groups
Intervention group : In this study gingival thickness on every patient will be measured with ultrasonography and then with gold standard method.
There are no other intervention groups.
Main outcome variables
Gingival thickness determination in 2 & 4 millimeters from free gingival level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211229053566N1
Registration date:2022-03-14, 1400/12/23
Registration timing:registered_while_recruiting
Last update:2022-03-14, 1400/12/23
Update count:0
Registration date
2022-03-14, 1400/12/23
Registrant information
Name
Mohammad Parham Ghomashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4421 7260
Email address
m.parham.gh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2023-01-05, 1401/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Intraoral Ultrasonography Accuracy Compared to Gold Standard Method in Gingival Thickness Assessment on Candidates for Crown Lengthening Surgery
Public title
Evaluation of Intraoral Ultrasonography Accuracy Compared to Gold Standard Method in Gingival Thickness Assessment on Candidates for Crown Lengthening Surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Normal and healthy periodontium
Non smokers
All anterior teeth and premolars should present in both maxilla and mandible
Patient must not be pregnant
Patient must not take any medication that would cause gingival hyperplasia
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences