Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369493
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-04-01
Brief Title:
Examining The Relationship Between Gingival Thickness and Tooth and Gingival Parameters
Sponsor:
Ondokuz Mayıs University
Organization:
Ondokuz Mayıs University
Study Overview
Official Title:
The Interaction of The Gingival And Tooth Morphometric Parameters On The Gingival Phenotype
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to assess whether there is a valid correlation between the identified multiple clinical and morphometric parameters and the gingival thickness
Detailed Description:
This study focused on the relationship between the clinical parameters of crown and gingival morphology and gingival phenotypes This study investigated the relationship between clinical and morphological parameters and gingival phenotype and included all teeth up to the first molar It also compares gingival phenotypes across arch locations and tooth groups
Study Design and Participants
This was a cross-sectional controlled randomized and analytical data study
This cross-sectional study was conducted with 50 participants 21 females 29 males aged 18-31 mean age 2242 287 years who applied to the Ondokuz Mayis University Faculty of Dentistrys Periodontology Department for periodontal treatment between September 2022 and May 2023 The statistical power of the study based on crown morphology was determined to be 80 with a type 1 error rate of 005 and a sample size of at least 42 people was determined The study was conducted in accordance with the principles of the Helsinki Declaration and with the approval of the Ondokuz Mayis University Clinical Research Ethics Committee OMUKAEK-Protocol No2022210 All participants provided written informed consent prior to enrollment
Fifty participants were divided into two groups based on the GT measurement taken from the point corresponding to the base of the gingival sulcus and categorized as thin GT 1 mm and thick GT ampampampampampgt 1 mm
Clinic Measurements
Clinical periodontal parameters including Plaque Index PI Gingival Index GI Bleeding on Probing Index BPI and probing pocket depth in six regions mesial labial midfacial distal labial mesial palatal midpalatal and distal palatal of each tooth with University of North Carolina UNC probe
To reduce pain before the direct measurement xylocaine spray 10 lidocaine was applied GT was measured by with a 20-gauge endodontic file in the buccal region of the incisors canines premolars and first molars in both the upper and lower jaws corresponding to the base of the gingival sulcus After fixing the plastic stopper the distance between the stopper and the tip of the endodontic file was measured using a modified digital caliper with 001 mm precision
Papilla Length PL was determined by measuring the distance between the zenith points of adjacent teeth and the perpendicular line connecting to the apex of the papilla with a periodontal probe Each tooth position had its mesial PL recorded
The functional method proposed by Olssoni et al was used to measure the keratinized gingival width KGW KGW was measured to the nearest 05 mm from the marginal gingivaampampampampamp39s mid-buccal position to the mucogingival junction
Measurements of Dental Stone Models
An alginate impression of the upper and lower jaw was taken in a stock tray and poured in Type 3 hard plaster according to the manufacturers specifications to obtain the study model The following assessments were made on the casts using a digital caliper according to the recommendations of Olssoni et al
Crown length CL was determined by measuring the distance between the gingival margin or if discernible the cemento-enamel junction and the incisal edge of the crown the crown
Crown width CW was determined by dividing the length of the crown into three portions of equal-height cervical C middle M and incisal I The distance between the approximal tooth surfaces was measured at the border between portions C and M
Following these measurements the ratio of crown width CW crown length CL was calculated for each tooth
Using a digital angle gauge with a measurement range of 0-9999º and a precision of 03º the gingival angle GA was calculated by connecting the angle between two lines at the most apical part of the gingival margin of each measured tooth and the most coronal parts of the two adjacent papillae
Intra-Examiner Repeatability
All measurements were performed by a single examiner SY and intra-examiner reliability was assessed by repeating the GT measurements on 10 randomly selected participants 2 weeks later
Statistical Analysis
Statistical analyses were performed using a statistical software package Spearmans Correlation analysis was used to examine the relationship between parameters that did not follow a normal distribution Binary Logistic Regression Analysis was used to examine the parameters related to gingival thickness receiver operating characteristic ROC analysis was used to determine the cut-off values for parameters in predicting gingival thickness To assess the consistency of repeated measurements by the researcher the intraclass correlation coefficient ICC was used Statistical significance level was considered pampampampampamplt 005 Data are expressed as means standard deviations and median minimum-maximum
The relationship and interaction of clinical and morphometric parameters were recorded on the basis of individuals tooth groups and dental arch location
Study Design and Participants
This was a cross-sectional controlled randomized and analytical data study
This cross-sectional study was conducted with 50 participants 21 females 29 males aged 18-31 mean age 2242 287 years who applied to the Ondokuz Mayis University Faculty of Dentistrys Periodontology Department for periodontal treatment between September 2022 and May 2023 The statistical power of the study based on crown morphology was determined to be 80 with a type 1 error rate of 005 and a sample size of at least 42 people was determined The study was conducted in accordance with the principles of the Helsinki Declaration and with the approval of the Ondokuz Mayis University Clinical Research Ethics Committee OMUKAEK-Protocol No2022210 All participants provided written informed consent prior to enrollment
Fifty participants were divided into two groups based on the GT measurement taken from the point corresponding to the base of the gingival sulcus and categorized as thin GT 1 mm and thick GT ampampampampampgt 1 mm
Clinic Measurements
Clinical periodontal parameters including Plaque Index PI Gingival Index GI Bleeding on Probing Index BPI and probing pocket depth in six regions mesial labial midfacial distal labial mesial palatal midpalatal and distal palatal of each tooth with University of North Carolina UNC probe
To reduce pain before the direct measurement xylocaine spray 10 lidocaine was applied GT was measured by with a 20-gauge endodontic file in the buccal region of the incisors canines premolars and first molars in both the upper and lower jaws corresponding to the base of the gingival sulcus After fixing the plastic stopper the distance between the stopper and the tip of the endodontic file was measured using a modified digital caliper with 001 mm precision
Papilla Length PL was determined by measuring the distance between the zenith points of adjacent teeth and the perpendicular line connecting to the apex of the papilla with a periodontal probe Each tooth position had its mesial PL recorded
The functional method proposed by Olssoni et al was used to measure the keratinized gingival width KGW KGW was measured to the nearest 05 mm from the marginal gingivaampampampampamp39s mid-buccal position to the mucogingival junction
Measurements of Dental Stone Models
An alginate impression of the upper and lower jaw was taken in a stock tray and poured in Type 3 hard plaster according to the manufacturers specifications to obtain the study model The following assessments were made on the casts using a digital caliper according to the recommendations of Olssoni et al
Crown length CL was determined by measuring the distance between the gingival margin or if discernible the cemento-enamel junction and the incisal edge of the crown the crown
Crown width CW was determined by dividing the length of the crown into three portions of equal-height cervical C middle M and incisal I The distance between the approximal tooth surfaces was measured at the border between portions C and M
Following these measurements the ratio of crown width CW crown length CL was calculated for each tooth
Using a digital angle gauge with a measurement range of 0-9999º and a precision of 03º the gingival angle GA was calculated by connecting the angle between two lines at the most apical part of the gingival margin of each measured tooth and the most coronal parts of the two adjacent papillae
Intra-Examiner Repeatability
All measurements were performed by a single examiner SY and intra-examiner reliability was assessed by repeating the GT measurements on 10 randomly selected participants 2 weeks later
Statistical Analysis
Statistical analyses were performed using a statistical software package Spearmans Correlation analysis was used to examine the relationship between parameters that did not follow a normal distribution Binary Logistic Regression Analysis was used to examine the parameters related to gingival thickness receiver operating characteristic ROC analysis was used to determine the cut-off values for parameters in predicting gingival thickness To assess the consistency of repeated measurements by the researcher the intraclass correlation coefficient ICC was used Statistical significance level was considered pampampampampamplt 005 Data are expressed as means standard deviations and median minimum-maximum
The relationship and interaction of clinical and morphometric parameters were recorded on the basis of individuals tooth groups and dental arch location
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None