Prosthetic TreatmentNCT06982898
Digitalization of Maxillo-mandibular Relation for Arches With Occlusal Support Loss
A study testing Fixed prosthesis with bimanual CR and intraoral scan in people with Prosthetic Treatment and Occlusal Analysis, run by Kıvanç Akça at 1 site in Turkey (Türkiye).
Trial summary
Accurate recording of the intermaxillary relationship is crucial for achieving successful restorative outcomes. In cases of occlusal support loss, determining and recording the intermaxillary relationship becomes more complex. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthetic Treatment, Occlusal Analysis, Digitalism
- What is being tested?
- Fixed prosthesis with bimanual CR and intraoral scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 30 Aug 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary participation after reading and understanding the informed consent form.
- Age between 18 and 65 years with completed growth and development.
- Healthy dental and periodontal condition.
- Presence of bilateral edentulism in the maxillary posterior region leading to occlusal support loss, requiring fixed prosthetic treatment.
- Fixed dentition present in the mandible.
Who cannot join
- Refusal to voluntarily participate after reading the informed consent form.
- General health condition unsuitable for prosthetic treatment.
- Use of removable prostheses in the mandibular arch.
- Presence of temporomandibular joint dysfunction, orofacial pain, or acute oral disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Dentistry
Ankara, 0623
About this study
Official title: Restorative Comparison of Facebow and Simplified Techniques for Digital Jaw Relation Records in Treatment of Occlusal Rehabilitation
Accurate recording of the intermaxillary relationship is crucial for achieving successful restorative outcomes.
In cases of occlusal support loss, determining and recording the intermaxillary relationship becomes more complex.
This study aims to compare the occlusal compatibility of restorations fabricated using either an intraoral scanner or a jaw motion tracking and analysis device for recording the intermaxillary relationship in patients with occlusal support loss.
Read the detailed description
This study is designed to fabricate bilateral fixed prosthetic restorations in the maxillary posterior region and to evaluate the clinical success, efficiency, and patient satisfaction associated with different intermaxillary relationship recording methods.
The study will compare the clinical outcomes of restorations produced using two techniques:
Group I: Centric relation (CR) determined by bimanual manipulation and recorded with an intraoral scanner.
Group II: Centric relation (CR) determined by neuromuscular deprogramming and recorded with a jaw movement/tracking analysis device.
All tooth preparations will follow standard preparation principles, ensuring minimum material thickness. Preparations will be completed by the investigator (ESK). After preparation, intraoral scans of the upper and lower jaws will be obtained using an intraoral scanner.
Centric relation will be recorded first with bimanual manipulation stabilized with wax, then digitized via intraoral scanning. In a subsequent session, centric relation will be recorded using a neuromuscular deprogrammer and jaw movement tracking analysis.
Both recordings will be sent to a dental laboratory for the fabrication of restorations. A randomization protocol will be applied to vary the adjustment order of the restorations fabricated by each method.
During clinical evaluation:
Distal and mesial proximal contacts will be checked and adjusted as needed.
Internal fit will be evaluated and corrected if necessary.
Occlusal adjustment will be performed using 100 µm and 40 µm articulation papers (Arti-Check micro-thin, Bausch, Cologne, Germany).
After occlusal adjustment:
The adjusted surfaces will be colored, photographed, and measured using ImageJ software to determine the adjusted surface area (in mm²).
Adjustment time and number of articulation paper applications will also be recorded.
These clinical parameters (adjusted area, adjustment time, and number of papers used) will be scored to assess the clinical success of the restorations.
Additionally, patient-reported outcomes will be collected:
Occlusal comfort and technique preference will be evaluated via a Visual Analog Scale (VAS, 0 = complete dissatisfaction, 10 = complete satisfaction) and a method preference survey.
This evaluation aims to determine which technique offers better patient comfort and overall satisfaction.
- Conditions
- Prosthetic Treatment, Occlusal Analysis, Digitalism
- Being tested
- Fixed prosthesis with bimanual CR and intraoral scan
- Keywords
- jaw relation, digital dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed prosthesis with bimanual CR and intraoral scanProcedure or surgery
Also called Fixed prosthesis with neuromuscular CR and jaw tracking
Tooth-supported fixed prostheses were fabricated using centric relation records obtained by two different methods:
- Bimanual manipulation technique, with jaw relation records captured using an intraoral scanner.
- Neuromuscular deprogramming technique, with jaw relation records obtained using a jaw movement tracking and analysis device.
| Study group | Role | What they receive |
|---|---|---|
| Determination of Intermaxillary Relationship in Patients with Posterior Support Loss | Experimental | For each participant, an intraoral scan was initially obtained using the bimanual manipulation method to determine the centric relation. Subsequently, the neuromuscular deprogramming method was applied, and recordings were obtained using a jaw movement tracking and analysis device.
During occlusal adjustment of the restorations fabricated based on both recording methods, the following parameters were evaluated: occlusal surface adaptation, adjustment time, and number of articulating paper applications. Receives: Procedure: Fixed prosthesis with bimanual CR and intraoral scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjustment Time for Restoration
The time required to adjust the restoration will be recorded in minutes and scored on a 0-4 scale as follows: 0 (≤1 min), 1 (1-5 min), 2 (5-10 min), 3 (10-15 min), 4 (≥15 min).
Measured: 1 year
Adjusted Surface Area of the Restoration
The surface area requiring adjustment will be measured in square millimeters (mm²) using ImageJ software and scored from 0 to 4: 0 (≤1 mm²), 1 (1-6 mm²), 2 (6-10 mm²), 3 (10-15 mm²), 4 (≥15 mm²).
Measured: 1 year
Number of Articulation Paper Uses
The number of articulation paper uses will be counted and scored from 0 to 4 as follows: 0 (2-4 uses), 1 (5-7), 2 (8-10), 3 (10-13), 4 (≥14 uses).
Measured: 1 year
Composite Clinical Success Score of the Restoration
The clinical success of each restoration will be evaluated using a composite score derived from three parameters:
Adjustment Time, Adjusted Surface Area,Number of Articulation Paper Uses.
Each parameter is scored from 0 to 4, yielding a total score between 0 and 12. Based on the total score, restorations will be categorized as follows:
Excellent (Score 0-1): Restoration has a clinically optimal fit. Occlusal contacts are properly and evenly distributed.
Successful (Score 2-4): Restoration shows good clinical fit with minor occlusal adjustments.
Moderate (Score 5-7): Restoration is clinically acceptable with occlusal adjustments.
Weak (Score 8-10): Restoration has issues in clinical fit and required major occlusal adjustments.
Unsuccessful (Score 11-12): Clinical fit is unacceptable. Adjustments caused morphological distortion or resulted in occlusal gaps. Restoration must be replaced.
This composite score will serve as the primary measure of overall clinical success.
Measured: 1 year
Secondary outcomes (1)
Occlusal Comfort Evaluated Using Visual Analog Scale
Secondary outcome will assess patient-reported occlusal comfort following the clinical application of the restoration. Occlusal comfort will be measured using a 10-point Visual Analog Scale (VAS), where 0 indicates no comfort and 10 indicates maximum comfort. Patients will rate their experience immediately after the restoration trial.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 May 2025
- Primary completion10 Jul 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Prosthetic TreatmentStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive two different prosthetic interventions based on different jaw relation record techniques. The outcomes will be compared within the same individuals.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kıvanç Akça
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor-investigator, Kıvanç Akça, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982898
- Sponsor's protocol ID
- KA-24002
- Status last verified
- May 2025
- First submitted
- 21 Apr 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because the study focuses on clinical and patient reported outcomes that are not structured for external distribution.
Publications
Jasz B, Ambrus S, Garay T, Schmidt P, Hermann P, Kormendi S, Jasz M. Different methods of determining centric relation - comparison with a digital mandibular motion analyser. BMC Oral Health. 2024 Mar 18;24(1):345. doi: 10.1186/s12903-024-04131-x.
PubMed 38500122Manfredini D, Ercoli C, Poggio CE, Carboncini F, Ferrari M. Centric relation-A biological perspective of a technical concept. J Oral Rehabil. 2023 Nov;50(11):1355-1361. doi: 10.1111/joor.13553. Epub 2023 Jul 11.
PubMed 37394665Revilla-Leon M, Fernandez-Estevan L, Barmak AB, Kois JC, Perez-Barquero JA. Accuracy of the maxillomandibular relationship at centric relation position recorded by using 3 different intraoral scanners with or without an optical jaw tracking system: An in vivo pilot study. J Dent. 2023 May;132:104478. doi: 10.1016/j.jdent.2023.104478. Epub 2023 Mar 6.
PubMed 36889536Revilla-Leon M, Zeitler JM, Kois DE, Kois JC. Utilizing an additively manufactured Kois deprogrammer to record centric relation: A simplified workflow and delivery technique. J Prosthet Dent. 2024 Jul;132(1):20-25. doi: 10.1016/j.prosdent.2022.04.034. Epub 2022 Aug 5.
PubMed 35934572Radu M, Radu D, Abboud M. Digital recording of a conventionally determined centric relation: A technique using an intraoral scanner. J Prosthet Dent. 2020 Feb;123(2):228-231. doi: 10.1016/j.prosdent.2018.12.004. Epub 2019 May 16.
PubMed 31104810Abdulateef S, Edher F, Hannam AG, Tobias DL, Wyatt CCL. Clinical accuracy and reproducibility of virtual interocclusal records. J Prosthet Dent. 2020 Dec;124(6):667-673. doi: 10.1016/j.prosdent.2019.11.014. Epub 2020 Feb 1.
PubMed 32014284Kordass B, Gartner C, Sohnel A, Bisler A, Voss G, Bockholt U, Seipel S. The virtual articulator in dentistry: concept and development. Dent Clin North Am. 2002 Jul;46(3):493-506, vi. doi: 10.1016/s0011-8532(02)00006-x.
PubMed 12222093Kattadiyil MT, Alzaid AA, Campbell SD. What Materials and Reproducible Techniques May Be Used in Recording Centric Relation? Best Evidence Consensus Statement. J Prosthodont. 2021 Apr;30(S1):34-42. doi: 10.1111/jopr.13321.
PubMed 33783085
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restorative Comparison of Facebow and Simplified Techniques for Digital Jaw Relation Records in Treatment of Occlusal Rehabilitation
- ClinicalTrials.gov ID
- NCT06982898
- Acronym / sponsor ID
- KA-24002
- Conditions
- Prosthetic Treatment, Occlusal Analysis, Digitalism
- Keywords
- jaw relation, digital dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kıvanç AkçaUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 1 May 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 21 May 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.
Accurate recording of the intermaxillary relationship is crucial for achieving successful restorative outcomes.
In cases of occlusal support loss, determining and recording the intermaxillary relationship becomes more complex.
This study aims to compare the occlusal compatibility of restorations fabricated using either an intraoral scanner or a jaw motion tracking and analysis device for recording the intermaxillary relationship in patients with occlusal support loss.
Detailed description
This study is designed to fabricate bilateral fixed prosthetic restorations in the maxillary posterior region and to evaluate the clinical success, efficiency, and patient satisfaction associated with different intermaxillary relationship recording methods.
The study will compare the clinical outcomes of restorations produced using two techniques:
Group I: Centric relation (CR) determined by bimanual manipulation and recorded with an intraoral scanner.
Group II: Centric relation (CR) determined by neuromuscular deprogramming and recorded with a jaw movement/tracking analysis device.
All tooth preparations will follow standard preparation principles, ensuring minimum material thickness. Preparations will be completed by the investigator (ESK). After preparation, intraoral scans of the upper and lower jaws will be obtained using an intraoral scanner.
Centric relation will be recorded first with bimanual manipulation stabilized with wax, then digitized via intraoral scanning. In a subsequent session, centric relation will be recorded using a neuromuscular deprogrammer and jaw movement tracking analysis.
Both recordings will be sent to a dental laboratory for the fabrication of restorations. A randomization protocol will be applied to vary the adjustment order of the restorations fabricated by each method.
During clinical evaluation:
Distal and mesial proximal contacts will be checked and adjusted as needed.
Internal fit will be evaluated and corrected if necessary.
Occlusal adjustment will be performed using 100 µm and 40 µm articulation papers (Arti-Check micro-thin, Bausch, Cologne, Germany).
After occlusal adjustment:
The adjusted surfaces will be colored, photographed, and measured using ImageJ software to determine the adjusted surface area (in mm²).
Adjustment time and number of articulation paper applications will also be recorded.
These clinical parameters (adjusted area, adjustment time, and number of papers used) will be scored to assess the clinical success of the restorations.
Additionally, patient-reported outcomes will be collected:
Occlusal comfort and technique preference will be evaluated via a Visual Analog Scale (VAS, 0 = complete dissatisfaction, 10 = complete satisfaction) and a method preference survey.
This evaluation aims to determine which technique offers better patient comfort and overall satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive two different prosthetic interventions based on different jaw relation record techniques. The outcomes will be compared within the same individuals.
| Arm | Type | Receives |
|---|---|---|
| Determination of Intermaxillary Relationship in Patients with Posterior Support Loss | Experimental | Procedure: Fixed prosthesis with bimanual CR and intraoral scanFor each participant, an intraoral scan was initially obtained using the bimanual manipulation method to determine the centric relation. Subsequently, the neuromuscular deprogramming method was applied, and recordings were obtained using a jaw movement tracking and analysis device. During occlusal adjustment of the restorations fabricated based on both recording methods, the following parameters were evaluated: occlusal surface adaptation, adjustment time, and number of articulating paper applications. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntary participation after reading and understanding the informed consent form.
- Age between 18 and 65 years with completed growth and development.
- Healthy dental and periodontal condition.
- Presence of bilateral edentulism in the maxillary posterior region leading to occlusal support loss, requiring fixed prosthetic treatment.
- Fixed dentition present in the mandible.
Key exclusion criteria (4 listed)
- Refusal to voluntarily participate after reading the informed consent form.
- General health condition unsuitable for prosthetic treatment.
- Use of removable prostheses in the mandibular arch.
- Presence of temporomandibular joint dysfunction, orofacial pain, or acute oral disease.
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 |
|---|---|---|
| Fixed prosthesis with bimanual CR and intraoral scanAlso: Fixed prosthesis with neuromuscular CR and jaw trackingTooth-supported fixed prostheses were fabricated using centric relation records obtained by two different methods: 1. Bimanual manipulation technique, with jaw relation records captured using an intraoral scanner. 2. Neuromuscular deprogramming technique, with jaw relation records obtained using a jaw movement tracking and analysis device. | Procedure or surgery | Determination of Intermaxillary Relationship in Patients with Posterior Support Loss |
Primary outcome
Adjustment Time for Restoration
Time frame: 1 year
The time required to adjust the restoration will be recorded in minutes and scored on a 0-4 scale as follows: 0 (≤1 min), 1 (1-5 min), 2 (5-10 min), 3 (10-15 min), 4 (≥15 min).
Adjusted Surface Area of the Restoration
Time frame: 1 year
The surface area requiring adjustment will be measured in square millimeters (mm²) using ImageJ software and scored from 0 to 4: 0 (≤1 mm²), 1 (1-6 mm²), 2 (6-10 mm²), 3 (10-15 mm²), 4 (≥15 mm²).
Number of Articulation Paper Uses
Time frame: 1 year
The number of articulation paper uses will be counted and scored from 0 to 4 as follows: 0 (2-4 uses), 1 (5-7), 2 (8-10), 3 (10-13), 4 (≥14 uses).
Composite Clinical Success Score of the Restoration
Time frame: 1 year
The clinical success of each restoration will be evaluated using a composite score derived from three parameters: Adjustment Time, Adjusted Surface Area,Number of Articulation Paper Uses. Each parameter is scored from 0 to 4, yielding a total score between 0 and 12. Based on the total score, restorations will be categorized as follows: Excellent (Score 0-1): Restoration has a clinically optimal fit. Occlusal contacts are properly and evenly distributed. Successful (Score 2-4): Restoration shows good clinical fit with minor occlusal adjustments. Moderate (Score 5-7): Restoration is clinically acceptable with occlusal adjustments. Weak (Score 8-10): Restoration has issues in clinical fit and required major occlusal adjustments. Unsuccessful (Score 11-12): Clinical fit is unacceptable. Adjustments caused morphological distortion or resulted in occlusal gaps. Restoration must be replaced. This composite score will serve as the primary measure of overall clinical success.
1 secondary outcome
Occlusal Comfort Evaluated Using Visual Analog Scale
Time frame: 1 year
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 28 Sep 2026.
- Background: PubMed 38500122Jasz B, Ambrus S, Garay T, Schmidt P, Hermann P, Kormendi S, Jasz M. Different methods of determining centric relation - comparison with a digital mandibular motion analyser. BMC Oral Health. 2024 Mar 18;24(1):345. doi: 10.1186/s12903-024-04131-x.
- Background: PubMed 37394665Manfredini D, Ercoli C, Poggio CE, Carboncini F, Ferrari M. Centric relation-A biological perspective of a technical concept. J Oral Rehabil. 2023 Nov;50(11):1355-1361. doi: 10.1111/joor.13553. Epub 2023 Jul 11.
- Background: PubMed 36889536Revilla-Leon M, Fernandez-Estevan L, Barmak AB, Kois JC, Perez-Barquero JA. Accuracy of the maxillomandibular relationship at centric relation position recorded by using 3 different intraoral scanners with or without an optical jaw tracking system: An in vivo pilot study. J Dent. 2023 May;132:104478. doi: 10.1016/j.jdent.2023.104478. Epub 2023 Mar 6.
- Background: PubMed 35934572Revilla-Leon M, Zeitler JM, Kois DE, Kois JC. Utilizing an additively manufactured Kois deprogrammer to record centric relation: A simplified workflow and delivery technique. J Prosthet Dent. 2024 Jul;132(1):20-25. doi: 10.1016/j.prosdent.2022.04.034. Epub 2022 Aug 5.
- Background: PubMed 31104810Radu M, Radu D, Abboud M. Digital recording of a conventionally determined centric relation: A technique using an intraoral scanner. J Prosthet Dent. 2020 Feb;123(2):228-231. doi: 10.1016/j.prosdent.2018.12.004. Epub 2019 May 16.
- Background: PubMed 32014284Abdulateef S, Edher F, Hannam AG, Tobias DL, Wyatt CCL. Clinical accuracy and reproducibility of virtual interocclusal records. J Prosthet Dent. 2020 Dec;124(6):667-673. doi: 10.1016/j.prosdent.2019.11.014. Epub 2020 Feb 1.
- Background: PubMed 12222093Kordass B, Gartner C, Sohnel A, Bisler A, Voss G, Bockholt U, Seipel S. The virtual articulator in dentistry: concept and development. Dent Clin North Am. 2002 Jul;46(3):493-506, vi. doi: 10.1016/s0011-8532(02)00006-x.
- Background: PubMed 33783085Kattadiyil MT, Alzaid AA, Campbell SD. What Materials and Reproducible Techniques May Be Used in Recording Centric Relation? Best Evidence Consensus Statement. J Prosthodont. 2021 Apr;30(S1):34-42. doi: 10.1111/jopr.13321.
- Individual participant dataSharing planned: No. IPD will not be shared because the study focuses on clinical and patient reported outcomes that are not structured for external distribution.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed prosthesis with bimanual CR and intraoral scan in people with Prosthetic Treatment and Occlusal Analysis, run by Kıvanç Akça 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 28 Sep 2026. 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?
Adjustment Time for Restoration (time frame: 1 year). The study lists 4 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 NCT06982898, which also lists 8 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 Sep 2026.