| CTRI Number |
CTRI/2022/02/040678 [Registered on: 28/02/2022] 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
|
To evaluate and correlate facial and anterior teeth proportions amongst different facial types |
|
Scientific Title of Study
|
Evaluation and Correlation of facial and anterior teeth proportions amongst different facial types |
| 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 and Research Centre |
| Address |
104 Department of Periodontics and Implantology
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 and Research Centre |
| Address |
104 Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills
Hingna Road
Nagpur 440019
Maharashtra
India
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 and Research Centre |
| Address |
104 Department of Periodontics and Implantology
VSPM Dental College and Research Centre
Digdoh Hills
Hingna Road
Nagpur 440019
Maharashtra
India
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhay P Kolte |
| Address |
104 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] |
|
|
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 and Research Centre Nagpur |
104 Department of Periodontics and Implantology
VSPM Dental College and 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 |
| VSPM Dental College and Research Centre Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
periodontally healthy males and females in the age range of 20-40 years |
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate & correlate facial and maxillary anterior teeth proportions amongst different facial types in periodontally healthy patients. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
01/03/2022 |
| 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 Applicable |
| 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 facial and maxillary anterior teeth proportions amongst different facial types 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 and implantology 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 100 males within an age range of 20-40 years. Group II – Will comprise of periodontally and systemically healthy 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. The study parameters of the patients will be assessed for facial height (FH). The FH will be measured from trichion (the front line of the hair in the midline) to menton (the lowest soft tissue point of the mandible) at rest. For the measurement of facial width the maximum horizontal distance between right and left facial boundary (bizygomatic width) at rest will be measured. For measurement of maxillary anterior tooth width the dimension will be obtained by measuring the maximum distance between the mesial and distal contact points of the tooth using digital caliper and using the caliberation on the DTS PRO software. For measurement of maxillary anterior tooth height the dimension will be obtained by measuring the maximum vertical distance from the cervical margin to the incisal edge of the tooth using digital caliper and the calibrations on the DTS PRO software. The ICOW will be calculated be determined by measuring the maxillary lip vermilion from the right commissure to the left commissure with digital DTS PRO software.
|