OcclusionNCT06343454
The Effect of Different Head Positions on Occlusal Contacts During Digital Interocclusal Bite Registration
A study testing Digital Interocclusal Record In Different Head Positions in people with Occlusion, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn about different head position's effect on occlusal contacts during digital interocclusal record. The main question aims to answer is: Are different head positions in physiological limits can be affected the occlusal contact during interocclusal record? Participants will be… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occlusion
- What is being tested?
- Digital Interocclusal Record In Different Head Positions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2023to 3 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals over 18 years of age,
- Individuals with natural dentition,
- Individuals with healthy head and neck movements within physiologic limits, - Individuals with Angle Class I skeletal relation
- Individuals with stable maximum intercuspal relation and absence of premature tooth contact.
- Individuals with radiologic and periodontal health of the teeth.
Who cannot join
- Individuals with general health problems
- Individuals with missing teeth
- Individuals with lack of posterior occlusal support or unstable occlusion
- Individuals with pain in the orofacial region and TMJ disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Head Positions on Occlusal Contacts
The goal of this clinical trial is to learn about different head position's effect on occlusal contacts during digital interocclusal record. The main question aims to answer is:
- Are different head positions in physiological limits can be affected the occlusal contact during interocclusal record? Participants will be asked to stand in three different physiological head positions (neutral, forward and backward) which are common in daily routine. In these positions, after maxillary and mandibular arch scans three different interocclusal records will be taken. Also for assessment of these records in digital occlusal analysis module (oJMA, zebras), three different oJMA record will be taken.
Researchers will compare neutral, forward and backward head positions to see if there are any difference in number, density and location of occlusal contacts.
Read the detailed description
The purpose of this clinical study was to compare, within physiological bounds, the occlusal contacts obtained with the interocclusal records taken with an intraoral scanner in three distinct head positions. The clinical protocol was approved by national ethical committees. After the consent form is accepted, those who fit the inclusion criteria will be enrolled in the study. The Power analysis led to the determination that 36 people would be needed to participate in the study.
The possibility of experiencing nausea during surface scanning and interocclusal records is one risk that could arise during the research. But routine scans carry a risk of developing this. It also has nothing to do with the study specifically. The process will end if there is severe nausea, anxiety, restlessness, anxiety during surface scanning, or an oJMA record. Participants will have the option to withdraw from the study at any time before or after enrollment opens. We'll find new people to take their place. Once there is a sufficient number of participants, registrations from these fully dentate individuals who do not require dental treatment will start. Study groups also formed to obtain digital interocclusal records in three head positions: "neutral head position (PN)," in which the head is positioned on the head-neck-spine plane; "forward head position/active feeding position (PF)," in which the head is positioned 30° in front of the head-neck-spine plane with forward head tilt; and "backward head position/drinking position (PB)," in which the head is positioned 45° behind the head-neck-spine plane with backward head tilt. PN considered the control group. The interocclusal records will be taken digitally with an IOS in the mentioned head positions.
Digital recording procedures will start after the examination. The recordings will be completed in two sessions. All recording methods have features that do not damage the oral tissues and do not cause pain or sensitivity. The first session will be completed within 10 minutes. First, a surface scan of the upper and lower jaws will be performed with an intraoral scanner and will be completed within three minutes. All scans will be performed in the entire arch and single-stage, according to the manufacturer's recommendations. Following the scan, missing regions and stitching errors will be monitored, and only scans devoid of these issues will be approved. Direct digital interocclusal records will then be taken and will be repeated for three different head positions. A manual goniometer (Goniometer, 360°; Saehan, Germany) will be used to determine the head position. The patient's head will next be adjusted to the predetermined position by using the dental chair's head support, and a goniometer will be used to confirm the adjustment. The interocclusal record will be performed in a static position, keeping the head fixed in the specified position. The record will be completed by starting from the most posterior tooth possible, moving horizontally anteriorly, and then posteriorly in the same direction. The same process will be repeated for the left interocclusal record. All interocclusal records will be achieved with auto-alignment.
The "digital occlusion analysis module" in the WINJAW+RC software program of oJMA will be used for detailed analysis of occlusal contacts. In the second session, the interocclusal records taken in the PN position will be transferred to this analysis module, and the necessary oJMA records will be. Before the oJMA record, the patient will be seated in the dental unit so that the head-neck-spine plane is perpendicular to the floor and the dental unit supports the back and head. Three oJMA recordings for the digital occlusion analysis module (oJMA, zebris) will be made, and these recordings will be used to assess the contacts that were previously acquired using the interocclusal records. The maxilla's three-dimensional (3D) position relative to the skull base and the lower jaw position record required for the digital occlusion module will be recorded. The evaluation will be performed by a single investigator using the digital occlusion analysis module, comparing the number, density, and location of occlusal contacts of the posterior teeth in the right and left quadrants in three different head positions. Within this area, cross-sections will be taken at 1mm intervals in the bucco-lingual (BL) direction with fixed x, y, and z coordinates. In each subject, the number of evaluated consecutive cross-sections in each quadrant will be determined. Each cross-section will be evaluated for the presence or absence of a contact point, the number and shape of the contact (point or area), the contact point's density, and the contact's anatomical location on the occlusal surface of the tooth. Each contact assessment will be expressed qualitatively as either present (1) or absent (0). A value of "1" will be given for each contact and all conditions obtained for its characteristics, and these values will be summed. This number will be divided by the total number of sections evaluated. Data will be generated based on this proportional value.
The comparison and statistical evaluation of these data with computer software constitute the experimental part of this study. The qualitative variables of all patients included in this study will be described with numbers and percentages. IBM SPSS Statistics 25 will be used for the data analysis. The Kolmogorov-Smirnov normality test will assess the data's conformity to a normal distribution. The Paired Samples t-test will be used to compare the data groups that are determined to be suitable for a normal distribution. The statistical significance level will be set at 0.05.
Each patient will be named by numbers (1, 2, 3...) and head position codes (PN, PB, PF), and no individual data will be included. Personal data will not be included in any software to be used during the study, will not be shared with anyone, and will remain confidential only with the physician. The surface scans and recording process will not provide any direct benefit for the participants. The results of this study can be used in dental education or scientific publications without revealing the patient's identity.
- Conditions
- Occlusion
- Being tested
- Digital Interocclusal Record In Different Head Positions
- Keywords
- Occlusal contacts, Head position, Digital occlusal analysis
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Interocclusal Record In Different Head PositionsOther
Recording the position of the upper and lower teeth in the bite position in different head positions with an intraoral scanner
| Study group | Role | What they receive |
|---|---|---|
| Neutral Head Position | Other | Neutral head position (PN), in which the head is positioned on the head-neck-spine plane. Receives: Other: Digital Interocclusal Record In Different Head Positions |
| Forward Head Position | Other | Forward head position/active feeding position (PF), in which head is positioned 30° in front of head-neck-spine plane with forward head tilt. Receives: Other: Digital Interocclusal Record In Different Head Positions |
| Backward Head Position | Other | Backward head position/drinking position (PB), in which the head is positioned 45° behind the head-neck-spine plane with backward head tilt. Receives: Other: Digital Interocclusal Record In Different Head Positions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Occlusal Contacts
Evaluating the number of contacts in terms of point and area contact.
Measured: Up to 24 weeks
Density of Occlusal Contacts
Evaluating the contact density by dividing the density in three groups (low, medium, and high).
Measured: Up to 24 weeks
Location of Occlusal Contacts
Evaluating the location of contacts in "functional cusp," "central fossa," and "non-functional cusp." sections.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start25 Oct 2023
- Primary completion27 Jan 2024
- Study completion3 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OcclusionStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Kahya Karaca, Hacettepe University
- Investigators
- Sinem Kahya Karaca, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343454
- Sponsor's protocol ID
- 2023/04-03(KA-22111)
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haralur S, Al-Gadhaan S, Al-Qahtani A, Mossa A, Al-Shehri W, Addas M. Influence of functional head postures on the dynamic functional occlusal parameters. Ann Med Health Sci Res. 2014 Jul;4(4):562-6. doi: 10.4103/2141-9248.139319.
PubMed 25221705Gupta S, Tarannum F, Gupta NK, Upadhyay M, Abdullah A. Effect of head posture on tooth contacts in dentate and complete denture wearers using computerized occlusal analysis system. J Indian Prosthodont Soc. 2017 Jul-Sep;17(3):250-254. doi: 10.4103/jips.jips_321_16.
PubMed 28936038Chapman RJ, Maness WL, Osorio J. Occlusal contact variation with changes in head position. Int J Prosthodont. 1991 Jul-Aug;4(4):377-81.
PubMed 1811633Kordass B, Amlang A, Hugger A, Behrendt C, Ruge S. Number and localization of occlusal contact areas on natural posterior teeth without dental findings - evaluations of the regional baseline study (SHIP-1) with the Greifswald Digital Analyzing System (GEDAS). Int J Comput Dent. 2022 Mar 24;25(1):47-56.
PubMed 35322652
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Head Positions on Occlusal Contacts
- ClinicalTrials.gov ID
- NCT06343454
- Acronym / sponsor ID
- 2023/04-03(KA-22111)
- Conditions
- Occlusion
- Keywords
- Occlusal contacts, Head position, Digital occlusal analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 27 Jan 2024 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 2 Apr 2024 (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.
The goal of this clinical trial is to learn about different head position's effect on occlusal contacts during digital interocclusal record. The main question aims to answer is:
- Are different head positions in physiological limits can be affected the occlusal contact during interocclusal record? Participants will be asked to stand in three different physiological head positions (neutral, forward and backward) which are common in daily routine. In these positions, after maxillary and mandibular arch scans three different interocclusal records will be taken. Also for assessment of these records in digital occlusal analysis module (oJMA, zebras), three different oJMA record will be taken.
Researchers will compare neutral, forward and backward head positions to see if there are any difference in number, density and location of occlusal contacts.
Detailed description
The purpose of this clinical study was to compare, within physiological bounds, the occlusal contacts obtained with the interocclusal records taken with an intraoral scanner in three distinct head positions. The clinical protocol was approved by national ethical committees. After the consent form is accepted, those who fit the inclusion criteria will be enrolled in the study. The Power analysis led to the determination that 36 people would be needed to participate in the study.
The possibility of experiencing nausea during surface scanning and interocclusal records is one risk that could arise during the research. But routine scans carry a risk of developing this. It also has nothing to do with the study specifically. The process will end if there is severe nausea, anxiety, restlessness, anxiety during surface scanning, or an oJMA record. Participants will have the option to withdraw from the study at any time before or after enrollment opens. We'll find new people to take their place. Once there is a sufficient number of participants, registrations from these fully dentate individuals who do not require dental treatment will start. Study groups also formed to obtain digital interocclusal records in three head positions: "neutral head position (PN)," in which the head is positioned on the head-neck-spine plane; "forward head position/active feeding position (PF)," in which the head is positioned 30° in front of the head-neck-spine plane with forward head tilt; and "backward head position/drinking position (PB)," in which the head is positioned 45° behind the head-neck-spine plane with backward head tilt. PN considered the control group. The interocclusal records will be taken digitally with an IOS in the mentioned head positions.
Digital recording procedures will start after the examination. The recordings will be completed in two sessions. All recording methods have features that do not damage the oral tissues and do not cause pain or sensitivity. The first session will be completed within 10 minutes. First, a surface scan of the upper and lower jaws will be performed with an intraoral scanner and will be completed within three minutes. All scans will be performed in the entire arch and single-stage, according to the manufacturer's recommendations. Following the scan, missing regions and stitching errors will be monitored, and only scans devoid of these issues will be approved. Direct digital interocclusal records will then be taken and will be repeated for three different head positions. A manual goniometer (Goniometer, 360°; Saehan, Germany) will be used to determine the head position. The patient's head will next be adjusted to the predetermined position by using the dental chair's head support, and a goniometer will be used to confirm the adjustment. The interocclusal record will be performed in a static position, keeping the head fixed in the specified position. The record will be completed by starting from the most posterior tooth possible, moving horizontally anteriorly, and then posteriorly in the same direction. The same process will be repeated for the left interocclusal record. All interocclusal records will be achieved with auto-alignment.
The "digital occlusion analysis module" in the WINJAW+RC software program of oJMA will be used for detailed analysis of occlusal contacts. In the second session, the interocclusal records taken in the PN position will be transferred to this analysis module, and the necessary oJMA records will be. Before the oJMA record, the patient will be seated in the dental unit so that the head-neck-spine plane is perpendicular to the floor and the dental unit supports the back and head. Three oJMA recordings for the digital occlusion analysis module (oJMA, zebris) will be made, and these recordings will be used to assess the contacts that were previously acquired using the interocclusal records. The maxilla's three-dimensional (3D) position relative to the skull base and the lower jaw position record required for the digital occlusion module will be recorded. The evaluation will be performed by a single investigator using the digital occlusion analysis module, comparing the number, density, and location of occlusal contacts of the posterior teeth in the right and left quadrants in three different head positions. Within this area, cross-sections will be taken at 1mm intervals in the bucco-lingual (BL) direction with fixed x, y, and z coordinates. In each subject, the number of evaluated consecutive cross-sections in each quadrant will be determined. Each cross-section will be evaluated for the presence or absence of a contact point, the number and shape of the contact (point or area), the contact point's density, and the contact's anatomical location on the occlusal surface of the tooth. Each contact assessment will be expressed qualitatively as either present (1) or absent (0). A value of "1" will be given for each contact and all conditions obtained for its characteristics, and these values will be summed. This number will be divided by the total number of sections evaluated. Data will be generated based on this proportional value.
The comparison and statistical evaluation of these data with computer software constitute the experimental part of this study. The qualitative variables of all patients included in this study will be described with numbers and percentages. IBM SPSS Statistics 25 will be used for the data analysis. The Kolmogorov-Smirnov normality test will assess the data's conformity to a normal distribution. The Paired Samples t-test will be used to compare the data groups that are determined to be suitable for a normal distribution. The statistical significance level will be set at 0.05.
Each patient will be named by numbers (1, 2, 3...) and head position codes (PN, PB, PF), and no individual data will be included. Personal data will not be included in any software to be used during the study, will not be shared with anyone, and will remain confidential only with the physician. The surface scans and recording process will not provide any direct benefit for the participants. The results of this study can be used in dental education or scientific publications without revealing the patient's identity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neutral Head Position | Other | Other: Digital Interocclusal Record In Different Head PositionsNeutral head position (PN), in which the head is positioned on the head-neck-spine plane. |
| Forward Head Position | Other | Other: Digital Interocclusal Record In Different Head PositionsForward head position/active feeding position (PF), in which head is positioned 30° in front of head-neck-spine plane with forward head tilt. |
| Backward Head Position | Other | Other: Digital Interocclusal Record In Different Head PositionsBackward head position/drinking position (PB), in which the head is positioned 45° behind the head-neck-spine plane with backward head tilt. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals over 18 years of age,
- Individuals with natural dentition,
- Individuals with healthy head and neck movements within physiologic limits, - Individuals with Angle Class I skeletal relation
- Individuals with stable maximum intercuspal relation and absence of premature tooth contact.
- Individuals with radiologic and periodontal health of the teeth.
Key exclusion criteria (4 listed)
- Individuals with general health problems
- Individuals with missing teeth
- Individuals with lack of posterior occlusal support or unstable occlusion
- Individuals with pain in the orofacial region and TMJ disorders.
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 |
|---|---|---|
| Digital Interocclusal Record In Different Head PositionsRecording the position of the upper and lower teeth in the bite position in different head positions with an intraoral scanner | Other | Backward Head Position, Forward Head Position, Neutral Head Position |
Primary outcome
Number of Occlusal Contacts
Time frame: Up to 24 weeks
Evaluating the number of contacts in terms of point and area contact.
Density of Occlusal Contacts
Time frame: Up to 24 weeks
Evaluating the contact density by dividing the density in three groups (low, medium, and high).
Location of Occlusal Contacts
Time frame: Up to 24 weeks
Evaluating the location of contacts in "functional cusp," "central fossa," and "non-functional cusp." sections.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 25221705Haralur S, Al-Gadhaan S, Al-Qahtani A, Mossa A, Al-Shehri W, Addas M. Influence of functional head postures on the dynamic functional occlusal parameters. Ann Med Health Sci Res. 2014 Jul;4(4):562-6. doi: 10.4103/2141-9248.139319.
- Background: PubMed 28936038Gupta S, Tarannum F, Gupta NK, Upadhyay M, Abdullah A. Effect of head posture on tooth contacts in dentate and complete denture wearers using computerized occlusal analysis system. J Indian Prosthodont Soc. 2017 Jul-Sep;17(3):250-254. doi: 10.4103/jips.jips_321_16.
- Results publication: PubMed 1811633Chapman RJ, Maness WL, Osorio J. Occlusal contact variation with changes in head position. Int J Prosthodont. 1991 Jul-Aug;4(4):377-81.
- Results publication: PubMed 35322652Kordass B, Amlang A, Hugger A, Behrendt C, Ruge S. Number and localization of occlusal contact areas on natural posterior teeth without dental findings - evaluations of the regional baseline study (SHIP-1) with the Greifswald Digital Analyzing System (GEDAS). Int J Comput Dent. 2022 Mar 24;25(1):47-56.
- Individual participant dataSharing planned: No
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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.
Sinem Kahya Karaca principal investigator
Hacettepe 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 Digital Interocclusal Record In Different Head Positions in people with Occlusion, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 2 Apr 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Occlusal Contacts (time frame: Up to 24 weeks). The study lists 3 primary outcomes in all. 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 NCT06343454, which also lists 4 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 2 Apr 2024.