Effect of Premolars Extraction on Bite ForceNCT07253337
Analysis of Bite Force Distribution After Premolars Extraction by Using T-scan Analysis System
A study testing T-scan analysis for bite force distribution in people with Effect of Premolars Extraction on Bite Force, run by Suez Canal University at 1 site in Egypt.
Trial summary
This study aims to assess the effect of first premolars extraction during orthodontic treatment bite force during the excursive mandibular movements using a digital occlusal analysis system. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Effect of Premolars Extraction on Bite Force
- What is being tested?
- T-scan analysis for bite force distribution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients with previous Orthodontic/ Orthopedic/ Orthognathic surgical treatment
- Patients with history of trauma or obvious/ gross facial asymmetry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
This study aims to assess the effect of first premolars extraction during orthodontic treatment bite force during the excursive mandibular movements using a digital occlusal analysis system.
Read the 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.
- Being tested
- T-scan analysis for bite force distribution
- Keywords
- occlusion T-scan extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-scan analysis for bite force distributionOther
T-scan analysis for bite force distribution for patients before and after the end of the orthodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients with premoalrs extraction | Experimental | Patients who will undergo 4 first premolars extraction Patients who will undergo upper first premolars extraction Receives: Other: T-scan analysis for bite force distribution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of bite force during excursive mandibular movements
Distribution of bite force during excursive mandibular movements before and after the end of the orthodontic treatment
Measured: 12-18 months
Secondary outcomes (1)
Effect of premolars extraction on distribution of bite force during mandibular excursive movements
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
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Jan 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Effect of Premolars Extraction on Bite ForceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- T-scan analysis for distribution of bite force before and after the end of the orthodontic treatment
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rim fathalla, Suez Canal University
- Investigators
- Rim M Fathalla, PhD of Orthodontics, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253337
- Sponsor's protocol ID
- 1041/2025
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 12028498Bottger H, Borgstedt T. [Computer-supported analysis of occlusion using T-Scan system. First report]. ZWR. 1989 Jul;98(7):584-5. German.
PubMed 2700857Floystrand 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.
PubMed 6958166Helkimo E, Carlsson GE, Helkimo M. Bite force and state of dentition. Acta Odontol Scand. 1977;35(6):297-303. doi: 10.3109/00016357709064128.
PubMed 271452Rohrle 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.
PubMed 29017762Sharma 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.
PubMed 24455051Haydar 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.
PubMed 1626529
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07253337
- Acronym / sponsor ID
- 1041/2025
- Keywords
- occlusion T-scan extraction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the effect of first premolars extraction during orthodontic treatment bite force during the excursive mandibular movements using a digital occlusal analysis system.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- T-scan analysis for distribution of bite force before and after the end of the orthodontic treatment
| Arm | Type | Receives |
|---|---|---|
| Patients with premoalrs extraction | Experimental | Other: T-scan analysis for bite force distributionPatients who will undergo 4 first premolars extraction Patients who will undergo upper first premolars extraction |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with previous Orthodontic/ Orthopedic/ Orthognathic surgical treatment
- Patients with history of trauma or obvious/ gross facial asymmetry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-scan analysis for bite force distributionT-scan analysis for bite force distribution for patients before and after the end of the orthodontic treatment | Other | Patients with premoalrs extraction |
Primary outcome
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
1 secondary outcome
Effect of premolars extraction on distribution of bite force during mandibular excursive movements
Time frame: 12-18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publication: PubMed 12028498Sultana 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.
- Results publication: PubMed 2700857Bottger H, Borgstedt T. [Computer-supported analysis of occlusion using T-Scan system. First report]. ZWR. 1989 Jul;98(7):584-5. German.
- Results publication: PubMed 6958166Floystrand 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.
- Results publication: PubMed 271452Helkimo E, Carlsson GE, Helkimo M. Bite force and state of dentition. Acta Odontol Scand. 1977;35(6):297-303. doi: 10.3109/00016357709064128.
- Results publication: PubMed 29017762Rohrle 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.
- Results publication: PubMed 24455051Sharma 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.
- Results publication: PubMed 1626529Haydar 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rim M Fathalla, PhD of Orthodontics principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-scan analysis for bite force distribution in people with Effect of Premolars Extraction on Bite Force, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of bite force during excursive mandibular movements (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07253337, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025; AzTrials last refreshed its copy on 27 Oct 2026.