Digitalization of Maxillo-mandibular Relation for Arches With Occlusal Support Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKıvanç Akça
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Fixed prosthesis with bimanual CR and intraoral scan
Procedure/SurgeryTooth-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.
Treatment groups
14 Participants
are divided into 1 treatment groupGroup A: Determination of Intermaxillary Relationship in Patients with Posterior Support LossExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
1 year2
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).
Time frame
1 year3
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).
Time frame
1 year4
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.
Time frame
1 yearSecondary 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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov