| CTRI Number |
CTRI/2022/03/040736 [Registered on: 02/03/2022] Trial Registered Prospectively |
| Last Modified On: |
26/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An illustrated study to evaluate and correlate facial height and lip length with gingival and interdental smile line in periodontally healthy patients |
|
Scientific Title of Study
|
Evaluation & Correlation of facial height and lip length with gingival and interdental smile line in Periodontally Healthy Patients: A Gender Based Evaluation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay P Kolte |
| Designation |
Professor and Guide HOD |
| Affiliation |
VSPM Dental College & Research Centre |
| Address |
104 Department of Periodontics & Implant Dentistry
VSPM Dental College and Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Professor and Guide HOD |
| Affiliation |
VSPM Dental College & Research Centre |
| Address |
104 Department of Periodontics & Implant Dentistry
VSPM Dental College and Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Professor and Guide HOD |
| Affiliation |
VSPM Dental College & Research Centre |
| Address |
104 Department of Periodontics & Implant Dentistry
VSPM Dental College and Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| 104, Department of Periodontics & Implant Dentistry,
VSPM Dental College & Research Centre,
Digdoh Hills, Hingna Road,
Nagpur 440019
Maharashtra, India.
|
|
|
Primary Sponsor
|
| Name |
Dr Divya Trivedi |
| Address |
104, Department of Periodontics & Implant Dentistry,
VSPM Dental College & Research Centre,
Digdoh Hills, Hingna Road,
Nagpur 440019
Maharashtra, India.
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
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 & Research Centre |
104, Department of Periodontics & Implant Dentistry,
VSPM Dental College & Research Centre,
Digdoh Hills, Hingna Road,
Nagpur 440019
Maharashtra, India.
Nagpur
MAHARASHTRA |
9011071467
drabhaypkolte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommitteeofVSPMDentalCollegeandResearchCentreNagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are willing to participate and sign the informed consent for this clinical trial.
2.Males and females between the age group of 20-40 years.
3. Healthy gingiva as assessed with a Plaque Index (Silness & Loe 1964) and Gingival Index (Loe & Silness 1963) between the score of 0–1.
4. Patients with fully erupted well-aligned maxillary Central Incisors, Lateral Incisors and Canines without orthodontic anomaly.
|
|
| ExclusionCriteria |
| Details |
1. Artificial crowns, fillings, attrition on anterior teeth.
2. Crowding or spacing in the anterior teeth.
3. Evidence of incomplete passive eruption.
4. Translocated/Tilted teeth.
5. Pregnancy or a history of taking medications known to increase the risk of gingival hyperplasia.
6. Patients diagnosed with destructive periodontal disease.
7. Facial asymmetry.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation & Correlation of Facial Height and Lip Length with gingival smile line (GSL) and interdental smile line (ISL) in Periodontally Healthy Patients. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate lip length and facial height in periodontally healthy patients.
2) To evaluate GSL and ISL in periodontally healthy patients.
3) To evaluate the amount of midfacial gingiva visible in GSL.
4) To evaluate the amount of interdental papilla visible in ISL.
5) To correlate the facial height, lip length with ISL and GSL in periodontally healthy patients.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted to evaluate and compare the facial height, lip length with Interdental Smile Line and Gingival Smile Line in Periodontally Healthy Patients. A total of 200 subjects with age range of 20-40 years including both male and female visiting the Department of Periodontics at VSPM Dental College and research centre Nagpur will be recruited. Study will be divided into 2 groups Group I – Will comprise of periodontally and systemically healthy patients. 100 males within an age range of 20-40 years. Group II – Will comprise of periodontally and systemically healthy patients. 100 females within an age range of 20-40 years. A brief description of entire procedure will be given to every patient before starting procedure. For all subjects following periodontal parameters will be recorded: 1. Plaque index (Silness and Loe 1964) 2. Gingival index (Loe and Silness 1963) The study parameters of the patients will be assessed for the measurement of facial height, FH was measured from trichion (the front line of the hair in the midline) to menton (the lowest soft tissue point of the mandible) at rest. Lip length, Lip length will be measured from subnasale to inferior most portion of maxillary lip at the midline, at rest and maximum smile position with a plastic ruler. The amount of mid-facial gingiva of central incisors of both sides (Right and left) will be measured as the distance of zenith point of central incisor to GSL line or inferior vermillion border of upper lip and the amount of interdental papillae of central incisor of both sides (Right and left) will be measured as the distance from tip of interdental papillae of central incisor to ISL line or inferior vermillion border of upper lip. |