Digitalization of Maxillo-mandibular Relation for Arches With Occlusal Support Loss
- Conditions
- Prosthetic TreatmentOcclusal AnalysisDigitalism
- Registration Number
- NCT06982898
- Lead Sponsor
- Kıvanç Akça
- Brief 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.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 14
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adjustment Time for Restoration 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Occlusal Comfort Evaluated Using Visual Analog Scale 1 year 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.
Trial Locations
- Locations (1)
Hacettepe University, Faculty of Dentistry
🇹🇷Ankara, Turkey
Hacettepe University, Faculty of Dentistry🇹🇷Ankara, TurkeyKıvanç Akça, DDS, PhDPrincipal Investigator