- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07253337
Analysis of Bite Force Distribution After Premolars Extraction by Using T-scan Analysis System
Effect of First Premolars Extraction During Orthodontic Treatment on Distribution of Bite Force During the Mandibular Excursive Movements: A Prospective Clinical Trial Using T-scan Occlusal Analysis System.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study sample consists of 16 patients, aged 14-25 years-old, who will be presented at the outpatient dental clinics and are seeking orthodontic treatment to relief crowding or to treat their proclined teeth. A written consent will be signed by them or their parents or caregivers after their approval to participate in this research study. The inclusion criteria are : age group from14 to 25 years, full complement of permanent teeth (excluding third molars) and the case analysis revealed extraction of their first premolars to relieve the malocclusion problem. As for the exclusion criteria; they include patients with previous Orthodontic/ Orthopedic/ Orthognathic surgical treatment, patients with history of trauma or obvious/ gross facial asymmetry.
Patients sampling:
Patients will be divided into two groups , each group includes eight patients according to the proposed treatment plan:
- Group I : Patients who will be treated with the extraction of their upper and lower first premolars .
- Group II : Patients who will be treated with extraction of their upper first premolars.
Methods:
Records will be taken on patients selected before initiating any orthodontic treatment to register the occlusal force distribution on teeth during the different excursive mandibular movements (right, left and protrusive mandibular movements) using the T-scan III system before orthodontic treatment and extraction of teeth .
- Orthodontic treatment of patients will be undertaken.
- After finishing the patients' treatment , the T-scan III system is used to measure the bite force distribution during mandibular excursive movements immediately after brackets debonding .
- The bite force measurements taken before and after treatment will be compared with each other .
Statistical Analysis:
In the current study, observations and all numerical data will be collected for statistical analysis using SPSS version 29 for Windows.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ismailia, Egypt
- Suez Canal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age group from14 to 25 years
- Full complement of permanent teeth (excluding third molars)
- The case analysis revealed extraction of their first premolars to relieve the malocclusion problem
Exclusion Criteria:
- Patients with previous Orthodontic/ Orthopedic/ Orthognathic surgical treatment
- Patients with history of trauma or obvious/ gross facial asymmetry.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with premoalrs extraction
Patients who will undergo 4 first premolars extraction Patients who will undergo upper first premolars extraction
|
T-scan analysis for bite force distribution for patients before and after the end of the orthodontic treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distribution of bite force during excursive mandibular movements
Time Frame: 12-18 months
|
Distribution of bite force during excursive mandibular movements before and after the end of the orthodontic treatment
|
12-18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of premolars extraction on distribution of bite force during mandibular excursive movements
Time Frame: 12-18 months
|
Effect of first premolars extraction on distribution of bite force during mandibular excursive movements using T-scan occlusal analysis system and if the extraction pattern is acontributing factor in the bite force
|
12-18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rim M Fathalla, PhD of Orthodontics, Suez Canal University
Publications and helpful links
General Publications
- Sultana MH, Yamada K, Hanada K. Changes in occlusal force and occlusal contact area after active orthodontic treatment: a pilot study using pressure-sensitive sheets. J Oral Rehabil. 2002 May;29(5):484-91. doi: 10.1046/j.1365-2842.2002.00849.x.
- Bottger H, Borgstedt T. [Computer-supported analysis of occlusion using T-Scan system. First report]. ZWR. 1989 Jul;98(7):584-5. German.
- Floystrand F, Kleven E, Oilo G. A novel miniature bite force recorder and its clinical application. Acta Odontol Scand. 1982;40(4):209-14. doi: 10.3109/00016358209019814.
- Helkimo E, Carlsson GE, Helkimo M. Bite force and state of dentition. Acta Odontol Scand. 1977;35(6):297-303. doi: 10.3109/00016357709064128.
- Rohrle O, Saini H, Ackland DC. Occlusal loading during biting from an experimental and simulation point of view. Dent Mater. 2018 Jan;34(1):58-68. doi: 10.1016/j.dental.2017.09.005. Epub 2017 Oct 7.
- Sharma A, Rahul GR, Poduval ST, Shetty K, Gupta B, Rajora V. History of materials used for recording static and dynamic occlusal contact marks: a literature review. J Clin Exp Dent. 2013 Feb 1;5(1):e48-53. doi: 10.4317/jced.50680. eCollection 2013 Feb 1.
- Haydar B, Ciger S, Saatci P. Occlusal contact changes after the active phase of orthodontic treatment. Am J Orthod Dentofacial Orthop. 1992 Jul;102(1):22-8. doi: 10.1016/0889-5406(92)70011-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1041/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Effect of Premolars Extraction on Bite Force
-
Mahidol UniversityCompletedthe Optimum Brushing Force for Dental Plaque Removal and the Effect of Brushing Force on Enamel CharacteristicThailand
-
The University of Texas Health Science Center,...TerminatedEffect of Methadone on the Duration on Mechanical VentilationUnited States
-
University of ReadingUnilever R&DNot yet recruitingFocus of Study: 1- Effect of Tea Consumption on Gut Microbiota | Focus of Study: 2- Effect of Tea Consumption on Body-iron StatusUnited Kingdom
-
University of South BohemiaCompletedEffect of Supplementation on PerformanceCzechia
-
Cardioangiologisches Centrum BethanienCompletedEffect of NOAC on POCT
-
Medipol UniversityCompleted
-
Aegerion Pharmaceuticals, Inc.CompletedEffect of Atorvastatin on the Pharmacokinetics of LomitapideUnited States
-
Thomas WalczykUnknownEffect of Iron Status on Occurrence of NTBISingapore
-
Sohag UniversityNot yet recruiting
-
University of Western Ontario, CanadaUnknownEffect of Superstarch on Soccer Performance
Clinical Trials on T-scan analysis for bite force distribution
-
Eskisehir Osmangazi UniversityCompletedTooth Ankylosis | Cemento-Osseous Dysplasia | Jaw Diseases / DiagnosisTurkey (Türkiye)
-
Orthospine Advance Health, Inc.CompletedBack Pain Lower Back ChronicUnited States
-
University of Mississippi Medical CenterNational Institute of Dental and Craniofacial Research (NIDCR)CompletedOsteoporosisUnited States
-
Cairo UniversityNot yet recruitingPrimary Teeth | Zirconia Crowns | Dental Occlusion | Pulp-treated Primary MolarsEgypt
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingCholangiocarcinoma | Adult Hepatocellular Carcinoma | Resectable Hepatocellular Carcinoma | Benign Liver Tumor | Metastases to LiverUnited States
-
Maastricht University Medical CenterDiabetes FondsCompletedDiabetes Mellitus, Type 2 | Diabetic CardiomyopathiesNetherlands
-
Boston Children's HospitalMassachusetts General Hospital; Massachusetts Institute of TechnologyRecruiting
-
Asrar AlahmadiAmgenRecruitingExtensive Stage Lung Small Cell CarcinomaUnited States
-
China-Japan Friendship HospitalActive, not recruitingTracheal Tube-related Tongue InjuryChina
-
MacroGenicsEli Lilly and CompanyTerminatedType 1 Diabetes MellitusUnited States