Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600867
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Method for Measuring Dental Mobility and Displacement Force
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of a Method for Measuring Dental Mobility and Displacement Force in Incisors With Periodontal Support Loss
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to investigate the use of a new method for measuring tooth mobility which includes control of force gf and labiallingualpalatal displacement mm of upper and lower incisors with tooth mobility It will take place during a single assessment session at the clinic of the Piracicaba Dental School FOP-Unicamp supervised by the research student Larissa Alexandra Fatinanzi and Prof Dr Enílson Antônio Sallum The evaluation will be conducted in person during regular clinical appointments without requiring additional travel or extended time beyond what is planned
The research will be conducted over two different days of appointments scheduled on the same day and time as regular clinical appointments occupying 30 minutes to 1 hour each
Day 1 A molding copy of the tooth will be performed Based on this step a customized instrument will be made necessary for evaluating the tooth with mobility
Customized Instrument The materials used will include acetate plate similar to a teeth whitening tray endodontic spacer used in root canal treatment tensiometer and dynamometer used in orthodontics to measure force and caliper a device for measuring in millimeters
Day 2 Evaluations will be conducted including mobility tooth with movement periodontal parameters examination of the gums and tooth support system and completion of a questionnaire with basic questions relating daily life to the clinical situation tooth with movement
The assessment of dental mobility involves moving the tooth forward and backward similar to routine clinical practice The amount of tooth movement will be measured in millimeters using the customized instrument Additionally a tensiometer and dynamometer will be used to measure the force The force applied by the instruments will not harm the tooth with mobility Two sets of dental mobility tests will be performed with a 1-minute interval between them The instruments used pose no risk to oral tissues are employed in dental treatments and are non-invasive All evaluations will be carried out on the same day of the appointment
The research will be conducted over two different days of appointments scheduled on the same day and time as regular clinical appointments occupying 30 minutes to 1 hour each
Day 1 A molding copy of the tooth will be performed Based on this step a customized instrument will be made necessary for evaluating the tooth with mobility
Customized Instrument The materials used will include acetate plate similar to a teeth whitening tray endodontic spacer used in root canal treatment tensiometer and dynamometer used in orthodontics to measure force and caliper a device for measuring in millimeters
Day 2 Evaluations will be conducted including mobility tooth with movement periodontal parameters examination of the gums and tooth support system and completion of a questionnaire with basic questions relating daily life to the clinical situation tooth with movement
The assessment of dental mobility involves moving the tooth forward and backward similar to routine clinical practice The amount of tooth movement will be measured in millimeters using the customized instrument Additionally a tensiometer and dynamometer will be used to measure the force The force applied by the instruments will not harm the tooth with mobility Two sets of dental mobility tests will be performed with a 1-minute interval between them The instruments used pose no risk to oral tissues are employed in dental treatments and are non-invasive All evaluations will be carried out on the same day of the appointment
Detailed Description:
This will be a descriptive study The population will consist of 20 volunteers diagnosed with periodontitis in stages II III and IV and grades A B and C meeting the following inclusion criteria periodontal pockets 4 mm anterior teeth regions 13-23 andor 33-43 with dental mobility grades 1 2 or 3 and periodontal attachment loss aged 18 years or older
Patient selection will initially be conducted through the electronic medical records of patients undergoing treatment at the Piracicaba Dental School - Unicamp clinic
The research will be carried out at the Periodontology Clinic of the Piracicaba Dental School FOP-Unicamp and the participation of volunteers will occur during regular clinical appointments under the responsibility of the masters student Larissa Alexandra Fatinanzi and supervision of Prof Dr Enílson Antônio Sallum
The method for evaluating dental mobility will include the use of a custom-made mold tray PET-G Bio-Art Soluções Inteligentes for each patient with adaptations for displacement readings an adapted tensiometer Morelli Orthodontics a dynamometer Zeusan Campinas two mirror handles an endodontic spacer with a stop and a caliper Mitutoyo Illinois USA Initially the participant will receive the Informed Consent Form ICF and upon acceptance the creation of the mold tray will begin based on the plaster model In the next step periodontal parameters PS NIC bone loss in mm and bone loss premature contacts and occlusal interferences will be assessed along with the OHIP-14 Oral Health Impact Profile followed by dental mobility assessment using the conventional method with subjective force mirror handles The subjective force will determine the tooth displacement in millimeters mm which will then be used to establish the necessary objective force measured by the tensiometerdynamometer to achieve the same displacement Mobility will be classified according to Lindhe and Nyman classification 1975
The chosen and adapted instrument for this research is the Orthodontic Tensiometer Morelli Orthodontics SorocabaSP Brazil with the inclusion of the Dynamometer Zeusan CampinasSP - Brazil for comparison purposes The force measurements are presented in gf gram-force ranging from 25gf to 250gf tensiometer and 125g to 300g Both instruments in this study will allow for the objective assessment of the routinely used subjective force and its possible relationship with clinical levels of attachment in order to understand the magnitude of the force needed to displace a dental element with periodontal disease The dynamometer will serve as a comparison tool and to confirm the accuracy of the tensiometer
For statistical analysis the comparison between the two techniques will be applied within the same group of subjects Each volunteer will serve as their own control reducing inter-subject variability Normal distribution will be tested using the Shapiro-Wilk test Comparisons will be made using Students t-test
Patient selection will initially be conducted through the electronic medical records of patients undergoing treatment at the Piracicaba Dental School - Unicamp clinic
The research will be carried out at the Periodontology Clinic of the Piracicaba Dental School FOP-Unicamp and the participation of volunteers will occur during regular clinical appointments under the responsibility of the masters student Larissa Alexandra Fatinanzi and supervision of Prof Dr Enílson Antônio Sallum
The method for evaluating dental mobility will include the use of a custom-made mold tray PET-G Bio-Art Soluções Inteligentes for each patient with adaptations for displacement readings an adapted tensiometer Morelli Orthodontics a dynamometer Zeusan Campinas two mirror handles an endodontic spacer with a stop and a caliper Mitutoyo Illinois USA Initially the participant will receive the Informed Consent Form ICF and upon acceptance the creation of the mold tray will begin based on the plaster model In the next step periodontal parameters PS NIC bone loss in mm and bone loss premature contacts and occlusal interferences will be assessed along with the OHIP-14 Oral Health Impact Profile followed by dental mobility assessment using the conventional method with subjective force mirror handles The subjective force will determine the tooth displacement in millimeters mm which will then be used to establish the necessary objective force measured by the tensiometerdynamometer to achieve the same displacement Mobility will be classified according to Lindhe and Nyman classification 1975
The chosen and adapted instrument for this research is the Orthodontic Tensiometer Morelli Orthodontics SorocabaSP Brazil with the inclusion of the Dynamometer Zeusan CampinasSP - Brazil for comparison purposes The force measurements are presented in gf gram-force ranging from 25gf to 250gf tensiometer and 125g to 300g Both instruments in this study will allow for the objective assessment of the routinely used subjective force and its possible relationship with clinical levels of attachment in order to understand the magnitude of the force needed to displace a dental element with periodontal disease The dynamometer will serve as a comparison tool and to confirm the accuracy of the tensiometer
For statistical analysis the comparison between the two techniques will be applied within the same group of subjects Each volunteer will serve as their own control reducing inter-subject variability Normal distribution will be tested using the Shapiro-Wilk test Comparisons will be made using Students t-test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None