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

NCT06982898 | Recruiting

• 1 other identifier: KA-24002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthetic Treatment; Occlusal Analysis; Digitalism

Keywords

jaw relation; digital dentistry

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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.

  1 year

Secondary Outcomes (1)

• Occlusal Comfort Evaluated Using Visual Analog Scale

  1 year

Study Arms (1)

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.

Procedure: Fixed prosthesis with bimanual CR and intraoral scan

Interventions

Fixed prosthesis with bimanual CR and intraoral scan 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.

Also known as: Fixed prosthesis with neuromuscular CR and jaw tracking

Determination of Intermaxillary Relationship in Patients with Posterior Support Loss

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kıvanç Akça: lead
• Hacettepe University: collaborator

Study Sites (1)

Hacettepe University, Faculty of Dentistry

Ankara, 0623, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• 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.

  PMID: 38500122 BACKGROUND

• 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.

  PMID: 37394665 BACKGROUND

• 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.

  PMID: 36889536 BACKGROUND

• 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.

  PMID: 35934572 BACKGROUND

• 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.

  PMID: 31104810 BACKGROUND

• 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.

  PMID: 32014284 BACKGROUND

• 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.

  PMID: 12222093 BACKGROUND

• 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.

  PMID: 33783085 BACKGROUND

Central Study Contacts

Ece Selen Koçar, DDS

CONTACT

+905319666026; ecekocar@gmail.com

Emre Bükücü, DDS

CONTACT

+905345412698; emrebuk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Prosthodontics

Model Details: All participants will receive two different prosthetic interventions based on different jaw relation record techniques. The outcomes will be compared within the same individuals.

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 21, 2025
• Study Start: August 1, 2024
• Primary Completion: September 10, 2025
• Study Completion: October 30, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)