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

K

Kıvanç Akça

Status

Enrolling

Conditions

Prosthetic Treatment
Occlusal Analysis
Digitalism

Treatments

Procedure: Fixed prosthesis with bimanual CR and intraoral scan

Study type

Interventional

Funder types

Other

Identifiers

NCT06982898
KA-24002

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Determination of Intermaxillary Relationship in Patients with Posterior Support Loss
Experimental group
Description:
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.
Treatment:
Procedure: Fixed prosthesis with bimanual CR and intraoral scan

Trial contacts and locations

1

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Central trial contact

Ece Selen Koçar, DDS; Emre Bükücü, DDS

Data sourced from clinicaltrials.gov

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