Digitalization of Maxillo-mandibular Relation for Arches With Occlusal Support Loss

NCT ID: NCT06982898

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-10-30

Brief Summary

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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

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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

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Prosthetic Treatment Occlusal Analysis Digitalism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive two different prosthetic interventions based on different jaw relation record techniques. The outcomes will be compared within the same individuals.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Determination of Intermaxillary Relationship in Patients with Posterior Support Loss

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.

Group Type EXPERIMENTAL

Fixed prosthesis with bimanual CR and intraoral scan

Intervention Type PROCEDURE

Tooth-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.

Interventions

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Fixed prosthesis with bimanual CR and intraoral scan

Tooth-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.

Intervention Type PROCEDURE

Other Intervention Names

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Fixed prosthesis with neuromuscular CR and jaw tracking

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* Presence of a pacemaker or implantable defibrillator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University Scientific Research Projects Coordination Unit

UNKNOWN

Sponsor Role collaborator

Kıvanç Akça

OTHER

Sponsor Role lead

Responsible Party

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Kıvanç Akça

Professor, Department of Prosthodontics

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hacettepe University, Faculty of Dentistry

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ece Selen Koçar, DDS

Role: CONTACT

+905319666026

Emre Bükücü, DDS

Role: CONTACT

+905345412698

Facility Contacts

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Kıvanç Akça, DDS, PhD

Role: primary

+9003123052240

References

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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.

Reference Type BACKGROUND
PMID: 38500122 (View on PubMed)

Manfredini 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.

Reference Type BACKGROUND
PMID: 37394665 (View on PubMed)

Revilla-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.

Reference Type BACKGROUND
PMID: 36889536 (View on PubMed)

Revilla-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.

Reference Type BACKGROUND
PMID: 35934572 (View on PubMed)

Radu 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.

Reference Type BACKGROUND
PMID: 31104810 (View on PubMed)

Abdulateef 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.

Reference Type BACKGROUND
PMID: 32014284 (View on PubMed)

Kordass 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.

Reference Type BACKGROUND
PMID: 12222093 (View on PubMed)

Kattadiyil 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.

Reference Type BACKGROUND
PMID: 33783085 (View on PubMed)

Other Identifiers

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KA-24002

Identifier Type: -

Identifier Source: org_study_id

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