| CTRI Number |
CTRI/2019/02/017818 [Registered on: 26/02/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
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Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the Gingival display and Gingival Zenith position display in anterior and premolar region of upper jaw and associate them with two different smile lines in both males and females. |
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Scientific Title of Study
|
Association of Gingival and Zenith Position display in maxillary anterior and premolar region with Gingival and Interdental Smile Line: A Gender Based Study. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay P Kolte |
| Designation |
Professor and Head |
| Affiliation |
Department of Periodontics and Implantology VSPM Dental College and Research Centre, Nagpur |
| Address |
Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
|
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Professor and Head |
| Affiliation |
Department of Periodontics and Implantology VSPM Dental College and Research Centre, Nagpur |
| Address |
Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
|
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Professor and Head |
| Affiliation |
Department of Periodontics and Implantology VSPM Dental College and Research Centre, Nagpur |
| Address |
Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
|
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Dr Abhay P Kolte |
| Address |
Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills, Hingna road
Nagpur: 440019
Maharashtra India
|
| Type of Sponsor |
Other [Dr. Abhay P Kolte] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhay P Kolte |
VSPM Dental College and Research CentreDigdoh Hills, Hingna road Nagpur: 440019 |
Department of Periodontics and Implantology
Nagpur
MAHARASHTRA |
9011071467
drabhaypkolte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM Dental College and Research Centre Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontally and systemically healthy males and females |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gingival Zenith Display and Interdental and Gingival smile line in maxillary anterior and premolar region |
Gingival and GZP display in maxillary anterior & premolar region will be compared and correlated with Gingival and Interdental Smile Line in both periodontally healthy males and females. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and females between the age group of 20-40 years.
2.Patients with healthy periodontal conditions, with a Plaque Index (Silness & Loe 1964) and Gingival Index (Loe & Silness 1963) between the score of 0–1.
3.Patients with fully erupted well-aligned maxillary Central Incisors, Lateral Incisors and Canines and Premolars without orthodontic anomaly.
|
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| ExclusionCriteria |
| Details |
Exclusion Criteria
1. Patients diagnosed with destructive periodontal disease.
2. Patients with a history of surgery in the anterior maxillary area, or open contact or crowding observed visually without aid.
3. Pregnant women or one with a history of taking medications known to increase the risk of gingival hyperplasia.
4. Those with the evidence of caries either on the interproximal surface or at cemento-enamel junction.
5. Patients having artificial crown, proximal/cervical restorations or abrasions on the Central Incisors, Lateral Incisors and Canines and Premolars.
6. If there is any evidence of incomplete passive eruption.
7.Patients having malaligned or Orthodontically treated, translocated/tilted teeth.
8. Those having crowding, spacing, gingival recession with maxillary anterior and premolar teeth.
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Gingival and Gingival Zenith Position (GZP) display in maxillary anterior and premolar region will be evaluated and correlated with Gingival and Interdental Smile Line (GSL & ISL) in periodontally healthy male and female patients. |
3 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Presence or absence of interdental papilla in maxillary anteriors and premolars on both right and left side of arch will be evaluated |
3 months |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2019 |
| Date of Study Completion (India) |
11/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Accepted (International Journal Of Esthetic Dentistry) |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
Background: Gingival tissues circumforaneous to the maxillary anterior teeth have been known to play a crucial role in a beautiful smile. With the growing demand for esthetics, preliminary reports suggest the tooth and gingival display in premolar areas during smiling. So, the present study examines the tooth and gingival exhibits in relations to the Gingival smile line (GSL) and Interdental smile line (ISL). Materials and methods: The study comprised of 120 periodontally healthy patients within an age range of 20 to 40 years, equally divided into two groups based on gender. Gingival zenith position (GZP), Gingival zenith level (GZL), presence or absence of interdental papilla, GSL and ISL were determined for maxillary anterior teeth till the second premolars. Results: The mean GZL for second premolars were found to be greatest followed by the first premolar and then the lateral incisors. The GZL for female patients were slightly higher than the males. The difference between GZL for the first and second premolars in both males and females was found to be statistically significant (p<0.0001). Majority of the patients i.e. 36 (60%) in males and 33(55%) in females displayed first premolar, whereas both the premolars were visible in 18(30%) and 22(36%) respectively. Conclusion: Within the smile corridor, majority of patients exhibit tooth and gingival display in the premolar region along with the maxillary anterior teeth. The GZL were greatest for the second premolars and least for the lateral incisor indicating considerable amount of gingival tissue display while smiling in GSL & ISL.
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