NCT06369493

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

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

Study Start

First participant enrolled

September 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

April 1, 2024

Last Update Submit

April 12, 2024

Conditions

Keywords

Gingival Phenotypegingival thicknessperiodontiumcrown morphology

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    1 month

Other Outcomes (1)

  • Evaluation of researcher reliability by ICC (Intra-Class Correlation Coefficient) in 10 participants in 2 weeks

    Baseline to 2 weeks

Study Arms (2)

Thin Gingival Phenotype

Thin phenotype group: Gingival thickness ≤1 mm

Thick Phenotype

Thick phenotype group: Gingival thickness \> 1 mm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants applying to Ondokuz Mayis University Department of Periodontology

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University Faculty of Dentistry Department of Periodonthology

Samsun, 55200, Turkey (Türkiye)

Location

Related Publications (26)

  • 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.

    PMID: 25210263BACKGROUND
  • Yin 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.

    PMID: 32075626BACKGROUND
  • Chou 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.

    PMID: 19444325BACKGROUND
  • Vlachodimou 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.

    PMID: 33806934BACKGROUND
  • Chow 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.

    PMID: 20618545BACKGROUND
  • AlQahtani 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.

    PMID: 27195228BACKGROUND
  • Fischer 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.

    PMID: 24580810BACKGROUND
  • Collins 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.

    PMID: 33515119BACKGROUND
  • Olsson 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.

    PMID: 7691897BACKGROUND
  • Muller 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.

    PMID: 15853970BACKGROUND
  • Vandana 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.

    PMID: 15966893BACKGROUND
  • Fischer 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.

    PMID: 34766469BACKGROUND
  • Kim 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.

    PMID: 31691970BACKGROUND
  • Shao 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.

    PMID: 30046153BACKGROUND
  • La 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.

    PMID: 23147165BACKGROUND
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    BACKGROUND
  • Fischer KR, Kunzlberger A, Donos N, Fickl S, Friedmann A. Gingival biotype revisited-novel classification and assessment tool. Clin Oral Investig. 2018 Jan;22(1):443-448. doi: 10.1007/s00784-017-2131-1. Epub 2017 May 27.

    PMID: 28551728BACKGROUND
  • Shah R, Sowmya NK, Mehta DS. Prevalence of gingival biotype and its relationship to clinical parameters. Contemp Clin Dent. 2015 Sep;6(Suppl 1):S167-71. doi: 10.4103/0976-237X.166824.

    PMID: 26604569BACKGROUND
  • Olsson M, Lindhe J. Periodontal characteristics in individuals with varying form of the upper central incisors. J Clin Periodontol. 1991 Jan;18(1):78-82. doi: 10.1111/j.1600-051x.1991.tb01124.x.

    PMID: 2045523BACKGROUND
  • Fischer KR, Grill E, Jockel-Schneider Y, Bechtold M, Schlagenhauf U, Fickl S. On the relationship between gingival biotypes and supracrestal gingival height, crown form and papilla height. Clin Oral Implants Res. 2014 Aug;25(8):894-8. doi: 10.1111/clr.12196. Epub 2013 May 30.

    PMID: 23718206BACKGROUND
  • Stellini E, Comuzzi L, Mazzocco F, Parente N, Gobbato L. Relationships between different tooth shapes and patient's periodontal phenotype. J Periodontal Res. 2013 Oct;48(5):657-62. doi: 10.1111/jre.12057. Epub 2013 Feb 27.

    PMID: 23441885BACKGROUND
  • Joshi A, Suragimath G, Zope SA, Ashwinirani SR, Varma SA. Comparison of Gingival Biotype between different Genders based on Measurement of Dentopapillary Complex. J Clin Diagn Res. 2017 Sep;11(9):ZC40-ZC45. doi: 10.7860/JCDR/2017/30144.10575. Epub 2017 Sep 1.

    PMID: 29207831BACKGROUND
  • Stein JM, Lintel-Hoping N, Hammacher C, Kasaj A, Tamm M, Hanisch O. The gingival biotype: measurement of soft and hard tissue dimensions - a radiographic morphometric study. J Clin Periodontol. 2013 Dec;40(12):1132-9. doi: 10.1111/jcpe.12169. Epub 2013 Oct 16.

    PMID: 24102580BACKGROUND
  • De Rouck T, Eghbali R, Collys K, De Bruyn H, Cosyn J. The gingival biotype revisited: transparency of the periodontal probe through the gingival margin as a method to discriminate thin from thick gingiva. J Clin Periodontol. 2009 May;36(5):428-33. doi: 10.1111/j.1600-051X.2009.01398.x.

    PMID: 19419444BACKGROUND
  • Belak S, Zizka R, Starosta M, Zapletalova J, Sedy J, Stefanatny M. The influence of gingival phenotype on the morphology of the maxillary central papilla. BMC Oral Health. 2021 Jan 23;21(1):43. doi: 10.1186/s12903-021-01400-x.

    PMID: 33485351BACKGROUND
  • Bolat SY, Guliyev R, Lutfioglu M. A comprehensive analysis of gingival phenotype: interaction and relationship between gingival and tooth morphometric parameters. BMC Oral Health. 2025 Sep 26;25(1):1450. doi: 10.1186/s12903-025-06821-6.

Study Design

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

Study Record Dates

First Submitted

April 1, 2024

First Posted

April 17, 2024

Study Start

September 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 18, 2023

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations