| CTRI Number |
CTRI/2020/11/029370 [Registered on: 25/11/2020] Trial Registered Prospectively |
| Last Modified On: |
25/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study is to evaluate and correlate Lip Length, Lip mobility, Intercommissural Width with Gingival and Interdental smile lines in Periodontally Healthy Patients. |
|
Scientific Title of Study
|
Evaluation and Correlation of Lip Length Lip mobility Intercommissural Width with Gingival and Interdental smile line in Periodontally Healthy Patients- A gender based evaluation. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay Kolte |
| Designation |
Professor and Guide HOD |
| Affiliation |
VSPM Dental College and Research Centre, Nagpur. |
| Address |
104 Department of Periodontics and Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
9011071467 |
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Professor and Guide HOD |
| Affiliation |
VSPM Dental College and Research Centre, Nagpur. |
| Address |
104 Department of Periodontics and Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra India
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
9011071467 |
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Professor and Guide HOD |
| Affiliation |
VSPM Dental College and Research Centre, Nagpur. |
| Address |
104 Department of Periodontics and Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra India
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
9011071467 |
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhay Kolte |
| Address |
104 Department of Periodontics and Implant Dentistry
VSPM Dental College and Research Centre
Digdoh Hills, Hingna Road
Nagpur 440019
Maharashtra India
|
| Type of Sponsor |
Other [Dr Abhay Kolte] |
|
|
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 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 |
| The Institutional Ethics Committee of VSPM Dental College & Research Centre, Nagpur. |
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 healthy males and females
|
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
none |
none |
|
|
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.
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation & Correlation of Lip Length, Lip mobility, Intercommisural Width (ICOW) with Gingival smile line (GSL) and Interdental smile line (ISL) in Periodontally Healthy Patients. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate lip length, lip mobility, GSL and ISL in periodontally healthy patients.
2) To evaluate ICOW at rest and on smiling in periodontally healthy patients.
3) To correlate ICOW with ISL and GSL in periodontally healthy patients.
4) To evaluate the amount of midfacial gingiva visible in GSL.
5) To evaluate the amount of interdental papilla visible in ISL.
6) To correlate the lip mobility, lip length with ISL and GSL in periodontally healthy patients.
|
Baseline |
|
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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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2020 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
- This study will be conducted to evaluate and compare the Lip Length, Lip Mobility and Intercommissural Width with Interdental Smile Line and Gingival Smile Line in Periodontally Healthy Patients.
- A total of 120 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. 60 males within an age range of 20-40 years.
- Group II – Will comprise of periodontally and systemically healthy patients. 60 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 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 lip mobility will be calculated by subtracting the incisal exposure at rest from the dentogingival exposure during maximum smile.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.The ICOW will be calculated clinically as the distance between the left commissure to right commissure which is measured with the help of vernier calliper.
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