| CTRI Number |
CTRI/2025/03/083263 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing lip closing strength in different skeletal teeth arrangement with different growth patterns |
|
Scientific Title of Study
|
Comparative Evaluation of Lip Closing Strength In Various Skeletal Malocclusions with different Growth Patterns :An In Vivo Study.” |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Singla |
| Designation |
Post Graduate student |
| Affiliation |
Rajasthan university of health sciences |
| Address |
surendera dental college and research institute,sriganganagar rajasthan 335001 india HH gardens,power house road sriganganagar Ganganagar RAJASTHAN 335001 India |
| Phone |
9462428749 |
| Fax |
|
| Email |
monikaortho2024@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Eenal Bhambri |
| Designation |
professor and head |
| Affiliation |
Rajasthan university of health sciences |
| Address |
surendera dental college and research institute,HH gardens,power house road,sgnr department of orthodontics and dentofacial orthopaedics,room number 3,surendera dental college and research institute,HH gardend,power house road,sriganganagar Ganganagar RAJASTHAN 335001 India |
| Phone |
8769829700 |
| Fax |
|
| Email |
dreenal700@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Monika Singla |
| Designation |
post graduate student |
| Affiliation |
Rajasthan university of health sciences |
| Address |
department of orthodontics and dentofacial orthopaedics,room no 3, surendera dental college and research institute,HHgardens ,power house road,ganganagar Ganganagar RAJASTHAN 335001 India |
| Phone |
9462428749 |
| Fax |
|
| Email |
monikaortho2024@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of orthodontics and dentofacial orthopeadics,Room number 3,A block,surendera dental college and research institute,sriganganagar,rajasthan,335001 |
|
|
Primary Sponsor
|
| Name |
Monika Singla |
| Address |
surendera dental college and research institute,sriganganagr,rajasthan,335001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Monika Singla |
surendera dental college and research institute,sriganganagar |
Depatment of orthodontics and dentofacial orthopaeidcs,room number 3,surendera dental college and research institute,HH gardens,power houser road,ganganagar,335001,india Ganganagar RAJASTHAN |
09462428749
monikaortho2024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE SURENDERA DENTAL COLLEGE AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
skeletal CLASS 1 , CLASS 2, CLASS 3 malocclusion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
patient with no history on long term medical usage,with healthy oral dental tissues,no history of previous orthodontic treatment,fall underrespected groups divided on the basis of cephalometric measurement |
|
| ExclusionCriteria |
| Details |
patient taking any medication,patient with open bite any any other systemic disorder |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare lip closing strength of force in patients with various skeletal malocclusions with different growth patterns in males and females at rest and during swallowing |
5 mintues |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To corelate the amount of lip force with different maolocclusions |
5 mintues |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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)
|
27/06/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Profile esthetics is generally becoming one of the major objectives of patients seeking orthodontic or orthognathic therapies nowadays. The lip is the pivotal feature affecting the esthetics of the lower third of face, especially as upper lip attracts the greatest attention. The main function of the lips, ie, oral competence, is controlled by Orbicularis oris muscle1 and the mentalis muscle. In cases like bimaxillary protrusion or severe class II div 1, lip incompetence often results in hypertrophic muscle activity as subjects unconsciously exert effort to keep their lips closed at rest. Apart from this muscle activity, Profit found that the resting lips also have a possible influence on the dentition2. Tomes almost 100 years ago advanced a theory that it is the perioral musculature and lips and tongue that principally determine the position of teeth1. The balance of these muscles is very important in the growth and development of craniofacial region and also credited in post treatment retention and stability. So, as an Orthodontist, it is important to measure the perioral muscle force but since pressure measurement is more difficult than strength, so force or strength measurement is preferable. It is hypothesized that this perioral muscle force will vary between different malocclusions. So, various studies have been conducted to relate the effect of lip force on craniofacial growth but with conflicting results. Posen conducted a study to measure the strength of lips in subjects with Angle Class II div 2 and subjects with bimaxillary protrusion and found that the subjects with class II divison 2 had high lip strength and subjects with bimaxillary protrusion had low lip strength3. Ingervall and Theur investigated the relationship between lip strength, bite and facial morphology and concluded that lip strength was small in children with large overjet , long dental arches, proclined incisors or Angle Class II malocclusion and children with large interlabial gap4. Ingervall and Janson Profit et al5 concluded that subjects with hypodivergent growth pattern have greater development of their perioral and masticatory musculature than the hyperdivergent growth pattern but Jung1 and Hodge et al found no significant correlation between horizontal skeletal pattern and the upper lip closing force in their studies1. Lambrechts et al6 investigated any difference in lip pressure on the basis of gender, Angle classification and characteristics of malocclusion and concluded that lip pressure was higher in males subjects than females and higher lip pressure in class I malocclusion than class II div 1 malocclusion subjects. Due to controversial results and none of the study on class III malocclusion, the research in various craniofacial patterns remains unclear. Many methods have been introduced to measure force or pressure put by lips in oral cavity like Pommeter consisting of a mouthpiece connected to a dynamometer, Electomyography , Y-meter , force sensing resistor device ( flexiforce low type) , Myometer160, bulb filled with some fluid and Oral Performance Instrument . However ,they all have one or the other drawbacks like the flexiform sensors are too costly and fragile and also produce errors when used for long time.The dynamometers are less sensitive.IOPI is also not affordable.The air filled bulbs have problem in positioning and reproductiblity within oral cavity. So, in this, study a MD30-60 SENSOR will be used to measure the vertical vector of lip closing force. It is cost effective, simple and easy to integrate, ultra thin, durable and delivers stable performance over time, waterproof, pressure sensitive for versatile applications. To the best of my knowledge,none of the study has evaluated lip force in various skeletal malocclusions with different growth patterns. So, the aim of this study is to evaluate and compare lip closing strength in various skeletal malocclusions with different growth patterns in males and females and lip strength at rest and during swallowing. |