NCT06343454

Brief Summary

The goal of this clinical trial is to learn about different head position's effect on occlusal contacts during digital interocclusal record. The main question aims to answer is: • Are different head positions in physiological limits can be affected the occlusal contact during interocclusal record? Participants will be asked to stand in three different physiological head positions (neutral, forward and backward) which are common in daily routine. In these positions, after maxillary and mandibular arch scans three different interocclusal records will be taken. Also for assessment of these records in digital occlusal analysis module (oJMA, zebras), three different oJMA record will be taken. Researchers will compare neutral, forward and backward head positions to see if there are any difference in number, density and location of occlusal contacts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 22, 2024

Last Update Submit

March 29, 2024

Conditions

Keywords

Occlusal contactsHead positionDigital occlusal analysis

Outcome Measures

Primary Outcomes (3)

  • Number of Occlusal Contacts

    Evaluating the number of contacts in terms of point and area contact.

    Up to 24 weeks

  • Density of Occlusal Contacts

    Evaluating the contact density by dividing the density in three groups (low, medium, and high).

    Up to 24 weeks

  • Location of Occlusal Contacts

    Evaluating the location of contacts in "functional cusp," "central fossa," and "non-functional cusp." sections.

    Up to 24 weeks

Study Arms (3)

Neutral Head Position

OTHER

Neutral head position (PN), in which the head is positioned on the head-neck-spine plane.

Other: Digital Interocclusal Record In Different Head Positions

Forward Head Position

OTHER

Forward head position/active feeding position (PF), in which head is positioned 30° in front of head-neck-spine plane with forward head tilt.

Other: Digital Interocclusal Record In Different Head Positions

Backward Head Position

OTHER

Backward head position/drinking position (PB), in which the head is positioned 45° behind the head-neck-spine plane with backward head tilt.

Other: Digital Interocclusal Record In Different Head Positions

Interventions

Recording the position of the upper and lower teeth in the bite position in different head positions with an intraoral scanner

Backward Head PositionForward Head PositionNeutral Head Position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals over 18 years of age,
  • Individuals with natural dentition,
  • Individuals with healthy head and neck movements within physiologic limits, - Individuals with Angle Class I skeletal relation
  • Individuals with stable maximum intercuspal relation and absence of premature tooth contact.
  • Individuals with radiologic and periodontal health of the teeth.

You may not qualify if:

  • Individuals with general health problems
  • Individuals with missing teeth
  • Individuals with lack of posterior occlusal support or unstable occlusion
  • Individuals with pain in the orofacial region and TMJ disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • Haralur S, Al-Gadhaan S, Al-Qahtani A, Mossa A, Al-Shehri W, Addas M. Influence of functional head postures on the dynamic functional occlusal parameters. Ann Med Health Sci Res. 2014 Jul;4(4):562-6. doi: 10.4103/2141-9248.139319.

    PMID: 25221705BACKGROUND
  • Gupta S, Tarannum F, Gupta NK, Upadhyay M, Abdullah A. Effect of head posture on tooth contacts in dentate and complete denture wearers using computerized occlusal analysis system. J Indian Prosthodont Soc. 2017 Jul-Sep;17(3):250-254. doi: 10.4103/jips.jips_321_16.

    PMID: 28936038BACKGROUND
  • Chapman RJ, Maness WL, Osorio J. Occlusal contact variation with changes in head position. Int J Prosthodont. 1991 Jul-Aug;4(4):377-81.

  • Kordass B, Amlang A, Hugger A, Behrendt C, Ruge S. Number and localization of occlusal contact areas on natural posterior teeth without dental findings - evaluations of the regional baseline study (SHIP-1) with the Greifswald Digital Analyzing System (GEDAS). Int J Comput Dent. 2022 Mar 24;25(1):47-56.

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Sinem Kahya Karaca

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 22, 2024

First Posted

April 2, 2024

Study Start

October 25, 2023

Primary Completion

January 27, 2024

Study Completion

March 3, 2024

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations