Gingival ThicknessNCT06369493
Examining The Relationship Between Gingival Thickness and Tooth and Gingival Parameters
An observational study of Gingival Thickness, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to assess whether there is a valid correlation between the identified multiple clinical and morphometric parameters and the gingival thickness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Thickness
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 18 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants applying to Ondokuz Mayis University Department of Periodontology
Who may be able to join
- Non-smokers ≥18 years old
- Periodontal health with ≤10% bleeding on full mouth probing.
- Participants with no history of systemic diseases or consistent medication use.
- Participants with teeth present in the maxillary and mandibular anterior and posterior regions, with a measured clinical attachment level (CAL) ≤ 3 mm; without buccal attachment loss or gingival inflammation
- Participants with no evidence of dental caries, crown shape alterations, or restorations affecting the occlusal edge in the maxillary and mandibular teeth, and no radiographic evidence of bone loss
- At least one tooth in maxillary and mandibular segments, representing molar and premolar regions
- No tooth loss due to periodontal reasons
Who cannot join
- Pregnant or lactating women
- Participants who have received or are receiving orthodontic treatment and using removable dentures or orthodontic devices
- Participants with a history of periodontitis or periodontal surgery involving teeth
- Presence of abrasion or erosion in teeth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University Faculty of Dentistry Department of Periodonthology
Samsun, 55200
About this study
Official title: The Interaction of The Gingival And Tooth Morphometric Parameters On The Gingival Phenotype
This study aims to assess whether there is a valid correlation between the identified multiple clinical and morphometric parameters and the gingival thickness.
Read the 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 22.42 ± 2.87 years) who applied to the Ondokuz Mayis University Faculty of Dentistry's 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 0.05, 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 No:2022/210. 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: \> 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 0.01 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 0.5 mm from the marginal gingiva\'s 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 manufacturer's 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 0-999.9º and a precision of 0.3º, 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. Spearman's 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 p\< 0.05 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.
- Conditions
- Gingival Thickness
- Keywords
- Gingival Phenotype, gingival thickness, periodontium, crown morphology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thin Gingival Phenotype | Thin phenotype group: Gingival thickness ≤1 mm | |
| Thick Phenotype | Thick phenotype group: Gingival thickness > 1 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the correlation between KGW, CW, CL PH parameters of GT measured in "mm" with a digital caliper with 0.001 mm precision in 1200 teeth in 50 participants using Spearman correlation analysis.
Spearman Correlation Analysis is a statistical technique in evaluating the correlation between clinical and morphometric parameters and is used to evaluate the relationship between variables. Variables GT, KGW, PH, CW, CL in 1200 teeth of 50 participants were measured in "mm" with a digital caliper with a precision of 0.001 mm. Spearman correlation coefficient takes a value between -1 and +1. +1 indicates a perfect positive monotonic relationship, -1 indicates a perfect negative monotonic relationship, and 0 indicates no relationship.
Measured: 1 month
Evaluation of the effect of GT on keratinized gingival width, measured in "mm" by digital caliper with a precision of 0.001 mm, both by binary logistic regression analysis of 50 participants.
In this study, GT, KGW are parametric variables and were measured in mm with a digital caliper with a precision of 0.001 mm. Binary logistic regression analysis is a statistical technique used to model the relationship of a dependent variable between two categorical classes. A significant p-value (<0.05) indicates that the independent variable (GT for this study) has a significant effect in the model. Binary logistic regression analysis expresses the effect of independent variables on the dependent variable in terms of log-odds. The coefficients of the model determine the magnitude and direction of the effect of the independent variables.
Measured: From September 2022 to May 2023
Examining the effect of age and gender of 50 participants on the gingival thickness measured in mm using binary logistic regression analysis.
In this study, GT is a parametric variable and is measured in mm. The effect of age and gender on GT of 50 participants over the age of 18 was examined with binary logistic regression analysis. Binary logistic regression analysis is a statistical technique used to model the relationship of a dependent variable between two categorical classes. A significant p value (<0.05) indicates that the independent variable (GT for this study) has a significant effect in the model. Binary logistic regression analysis expresses the effect of independent variables on the dependent variable in log-odds terms. The coefficients of the model determine the magnitude and direction of the effect of the independent variables.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Sep 2022
- Primary completion1 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Gingival ThicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sude Yildirim, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369493
- Sponsor's protocol ID
- OMUKAEK: 2022/210
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kolte R, Kolte A, Mahajan A. Assessment of gingival thickness with regards to age, gender and arch location. J Indian Soc Periodontol. 2014 Jul;18(4):478-81. doi: 10.4103/0972-124X.138699.
PubMed 25210263Yin XJ, Wei BY, Ke XP, Zhang T, Jiang MY, Luo XY, Sun HQ. Correlation between clinical parameters of crown and gingival morphology of anterior teeth and periodontal biotypes. BMC Oral Health. 2020 Feb 19;20(1):59. doi: 10.1186/s12903-020-1040-x.
PubMed 32075626Chou YH, Tsai CC, Wang JC, Ho YP, Ho KY, Tseng CC. New classification of crown forms and gingival characteristics in taiwanese. Open Dent J. 2008 Nov 28;2:114-9. doi: 10.2174/1874210600802010114.
PubMed 19444325Vlachodimou E, Fragkioudakis I, Vouros I. Is There an Association between the Gingival Phenotype and the Width of Keratinized Gingiva? A Systematic Review. Dent J (Basel). 2021 Mar 23;9(3):34. doi: 10.3390/dj9030034.
PubMed 33806934Chow YC, Eber RM, Tsao YP, Shotwell JL, Wang HL. Factors associated with the appearance of gingival papillae. J Clin Periodontol. 2010 Aug 1;37(8):719-27. doi: 10.1111/j.1600-051X.2010.01594.x. Epub 2010 Jul 1.
PubMed 20618545AlQahtani NA, Haralur SB, AlMaqbol M, AlMufarrij AJ, Al Dera AA, Al-Qarni M. Distribution of smile line, gingival angle and tooth shape among the Saudi Arabian subpopulation and their association with gingival biotype. J Int Soc Prev Community Dent. 2016 Apr;6(Suppl 1):S53-8. doi: 10.4103/2231-0762.181168.
PubMed 27195228Fischer KR, Richter T, Kebschull M, Petersen N, Fickl S. On the relationship between gingival biotypes and gingival thickness in young Caucasians. Clin Oral Implants Res. 2015 Aug;26(8):865-869. doi: 10.1111/clr.12356. Epub 2014 Mar 1.
PubMed 24580810Collins JR, Pannuti CM, Veras K, Ogando G, Brache M. Gingival phenotype and its relationship with different clinical parameters: a study in a Dominican adult sample. Clin Oral Investig. 2021 Aug;25(8):4967-4973. doi: 10.1007/s00784-021-03806-x. Epub 2021 Jan 29.
PubMed 33515119Olsson M, Lindhe J, Marinello CP. On the relationship between crown form and clinical features of the gingiva in adolescents. J Clin Periodontol. 1993 Sep;20(8):570-7. doi: 10.1111/j.1600-051x.1993.tb00773.x.
PubMed 7691897Muller HP, Kononen E. Variance components of gingival thickness. J Periodontal Res. 2005 Jun;40(3):239-44. doi: 10.1111/j.1600-0765.2005.00798.x.
PubMed 15853970Vandana KL, Savitha B. Thickness of gingiva in association with age, gender and dental arch location. J Clin Periodontol. 2005 Jul;32(7):828-30. doi: 10.1111/j.1600-051X.2005.00757.x.
PubMed 15966893Fischer KR, Buchel J, Kauffmann F, Heumann C, Friedmann A, Schmidlin PR. Gingival phenotype distribution in young Caucasian women and men - An investigative study. Clin Exp Dent Res. 2022 Feb;8(1):374-379. doi: 10.1002/cre2.482. Epub 2021 Nov 11.
PubMed 34766469Kim DM, Bassir SH, Nguyen TT. Effect of gingival phenotype on the maintenance of periodontal health: An American Academy of Periodontology best evidence review. J Periodontol. 2020 Mar;91(3):311-338. doi: 10.1002/JPER.19-0337. Epub 2020 Jan 16.
PubMed 31691970Shao Y, Yin L, Gu J, Wang D, Lu W, Sun Y. Assessment of Periodontal Biotype in a Young Chinese Population using Different Measurement Methods. Sci Rep. 2018 Jul 25;8(1):11212. doi: 10.1038/s41598-018-29542-z.
PubMed 30046153La Rocca AP, Alemany AS, Levi P Jr, Juan MV, Molina JN, Weisgold AS. Anterior maxillary and mandibular biotype: relationship between gingival thickness and width with respect to underlying bone thickness. Implant Dent. 2012 Dec;21(6):507-15. doi: 10.1097/ID.0b013e318271d487.
PubMed 23147165
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interaction of The Gingival And Tooth Morphometric Parameters On The Gingival Phenotype
- ClinicalTrials.gov ID
- NCT06369493
- Acronym / sponsor ID
- OMUKAEK: 2022/210
- Conditions
- Gingival Thickness
- Keywords
- Gingival Phenotype, gingival thickness, periodontium, crown morphology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 22.42 ± 2.87 years) who applied to the Ondokuz Mayis University Faculty of Dentistry's 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 0.05, 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 No:2022/210. 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: \&amp;amp;amp;amp;gt; 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 0.01 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 0.5 mm from the marginal gingiva\&amp;amp;amp;amp;#39;s 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 manufacturer's 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 0-999.9º and a precision of 0.3º, 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. Spearman's 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 p\&amp;amp;amp;amp;lt; 0.05 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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thin Gingival Phenotype | – | –Thin phenotype group: Gingival thickness ≤1 mm |
| Thick Phenotype | – | –Thick phenotype group: Gingival thickness > 1 mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants applying to Ondokuz Mayis University Department of Periodontology
Key inclusion criteria (7 listed)
- Non-smokers ≥18 years old
- Periodontal health with ≤10% bleeding on full mouth probing.
- Participants with no history of systemic diseases or consistent medication use.
- Participants with teeth present in the maxillary and mandibular anterior and posterior regions, with a measured clinical attachment level (CAL) ≤ 3 mm; without buccal attachment loss or gingival inflammation
- Participants with no evidence of dental caries, crown shape alterations, or restorations affecting the occlusal edge in the maxillary and mandibular teeth, and no radiographic evidence of bone loss
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Participants who have received or are receiving orthodontic treatment and using removable dentures or orthodontic devices
- Participants with a history of periodontitis or periodontal surgery involving teeth
- Presence of abrasion or erosion in teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the correlation between KGW, CW, CL PH parameters of GT measured in "mm" with a digital caliper with 0.001 mm precision in 1200 teeth in 50 participants using Spearman correlation analysis.
Time frame: 1 month
Spearman Correlation Analysis is a statistical technique in evaluating the correlation between clinical and morphometric parameters and is used to evaluate the relationship between variables. Variables GT, KGW, PH, CW, CL in 1200 teeth of 50 participants were measured in "mm" with a digital caliper with a precision of 0.001 mm. Spearman correlation coefficient takes a value between -1 and +1. +1 indicates a perfect positive monotonic relationship, -1 indicates a perfect negative monotonic relationship, and 0 indicates no relationship.
Evaluation of the effect of GT on keratinized gingival width, measured in "mm" by digital caliper with a precision of 0.001 mm, both by binary logistic regression analysis of 50 participants.
Time frame: From September 2022 to May 2023
In this study, GT, KGW are parametric variables and were measured in mm with a digital caliper with a precision of 0.001 mm. Binary logistic regression analysis is a statistical technique used to model the relationship of a dependent variable between two categorical classes. A significant p-value (<0.05) indicates that the independent variable (GT for this study) has a significant effect in the model. Binary logistic regression analysis expresses the effect of independent variables on the dependent variable in terms of log-odds. The coefficients of the model determine the magnitude and direction of the effect of the independent variables.
Examining the effect of age and gender of 50 participants on the gingival thickness measured in mm using binary logistic regression analysis.
Time frame: 1 month
In this study, GT is a parametric variable and is measured in mm. The effect of age and gender on GT of 50 participants over the age of 18 was examined with binary logistic regression analysis. Binary logistic regression analysis is a statistical technique used to model the relationship of a dependent variable between two categorical classes. A significant p value (<0.05) indicates that the independent variable (GT for this study) has a significant effect in the model. Binary logistic regression analysis expresses the effect of independent variables on the dependent variable in log-odds terms. The coefficients of the model determine the magnitude and direction of the effect of the independent variables.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 25210263Kolte R, Kolte A, Mahajan A. Assessment of gingival thickness with regards to age, gender and arch location. J Indian Soc Periodontol. 2014 Jul;18(4):478-81. doi: 10.4103/0972-124X.138699.
- Background: PubMed 32075626Yin XJ, Wei BY, Ke XP, Zhang T, Jiang MY, Luo XY, Sun HQ. Correlation between clinical parameters of crown and gingival morphology of anterior teeth and periodontal biotypes. BMC Oral Health. 2020 Feb 19;20(1):59. doi: 10.1186/s12903-020-1040-x.
- Background: PubMed 19444325Chou YH, Tsai CC, Wang JC, Ho YP, Ho KY, Tseng CC. New classification of crown forms and gingival characteristics in taiwanese. Open Dent J. 2008 Nov 28;2:114-9. doi: 10.2174/1874210600802010114.
- Background: PubMed 33806934Vlachodimou E, Fragkioudakis I, Vouros I. Is There an Association between the Gingival Phenotype and the Width of Keratinized Gingiva? A Systematic Review. Dent J (Basel). 2021 Mar 23;9(3):34. doi: 10.3390/dj9030034.
- Background: PubMed 20618545Chow YC, Eber RM, Tsao YP, Shotwell JL, Wang HL. Factors associated with the appearance of gingival papillae. J Clin Periodontol. 2010 Aug 1;37(8):719-27. doi: 10.1111/j.1600-051X.2010.01594.x. Epub 2010 Jul 1.
- Background: PubMed 27195228AlQahtani NA, Haralur SB, AlMaqbol M, AlMufarrij AJ, Al Dera AA, Al-Qarni M. Distribution of smile line, gingival angle and tooth shape among the Saudi Arabian subpopulation and their association with gingival biotype. J Int Soc Prev Community Dent. 2016 Apr;6(Suppl 1):S53-8. doi: 10.4103/2231-0762.181168.
- Background: PubMed 24580810Fischer KR, Richter T, Kebschull M, Petersen N, Fickl S. On the relationship between gingival biotypes and gingival thickness in young Caucasians. Clin Oral Implants Res. 2015 Aug;26(8):865-869. doi: 10.1111/clr.12356. Epub 2014 Mar 1.
- Background: PubMed 33515119Collins JR, Pannuti CM, Veras K, Ogando G, Brache M. Gingival phenotype and its relationship with different clinical parameters: a study in a Dominican adult sample. Clin Oral Investig. 2021 Aug;25(8):4967-4973. doi: 10.1007/s00784-021-03806-x. Epub 2021 Jan 29.
- Background: PubMed 7691897Olsson M, Lindhe J, Marinello CP. On the relationship between crown form and clinical features of the gingiva in adolescents. J Clin Periodontol. 1993 Sep;20(8):570-7. doi: 10.1111/j.1600-051x.1993.tb00773.x.
- Background: PubMed 15853970Muller HP, Kononen E. Variance components of gingival thickness. J Periodontal Res. 2005 Jun;40(3):239-44. doi: 10.1111/j.1600-0765.2005.00798.x.
- Background: PubMed 15966893Vandana KL, Savitha B. Thickness of gingiva in association with age, gender and dental arch location. J Clin Periodontol. 2005 Jul;32(7):828-30. doi: 10.1111/j.1600-051X.2005.00757.x.
- Background: PubMed 34766469Fischer KR, Buchel J, Kauffmann F, Heumann C, Friedmann A, Schmidlin PR. Gingival phenotype distribution in young Caucasian women and men - An investigative study. Clin Exp Dent Res. 2022 Feb;8(1):374-379. doi: 10.1002/cre2.482. Epub 2021 Nov 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Thickness, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the correlation between KGW, CW, CL PH parameters of GT measured in "mm" with a digital caliper with 0.001 mm precision in 1200 teeth in 50 participants using Spearman correlation analysis. (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369493, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.