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Completed

NCT Number: NCT01420536

Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

The objective of this study is to compare the canine guidance (CG) and bilateral balanced occlusion (BBO) on denture satisfaction and kinesiographic parameters of complete denture wearers, by means of a cross-over trial. Edentulous patients will receive new maxillary and mandibular complete dentures and, after the intraoral adjustments and adaptation period, will randomly receive a sequence of occlusal schemes: BBO followed by CG, or CG followed by BBO.

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Key information

Conditions

Edentulous Mouth Behavior Bites and Stings Chemically-Induced Disorders Edentulous Jaw Health Behavior Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Patient Acceptance of Health Care Patient Satisfaction Poisoning Stomatognathic Diseases Tooth Diseases Treatment Adherence and Compliance Wounds and Injuries

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)

Araraquara, São Paulo, 14801-903, Brazil

About this study

Reference for published version of the complete study:

Paleari AG, Marra J, Rodriguez LS, De Souza RF, Pero AC, De A Mollo Jr F, Compagnoni MA. A cross-over randomised clinical trial of eccentric occlusion in complete dentures.J Oral Rehabil. 2012 Apr 9. doi: 10.1111/j.1365-2842.2012.02299.x. [Epub ahead of print]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients needing new complete dentures
  • Mentally receptiveness
  • Absence of dysfunctional disorders of the masticatory system
  • Normal volume and resilience of residual edentulous ridges
  • Absence of debilitating systemic diseases

Exclusion criteria

  • Use of cardiac pacemaker
  • Refusal to participate or inability to provide informed consent

Treatment and study plan

Occlusal scheme

Procedure

Before enrollment, all participants will receive conventional complete dentures adjusted according to the bilateral balanced occlusion concept.

Following randomization, canine guidance will be achieved by adding composite resin (Restorative Z100, 3M Brazil, Sumaré, SP, Brazil) on the lingual surface of the maxillary canines. A sham comparator will also employ the addition of composite, but without changing eccentric contacts.

Other names: Dental articulation, Denture oclusion

Primary outcomes

  1. Denture Satisfaction

    Time frame: 30 days

    Assessed by a questionnaire questionnaire based on the criteria used by Celebic and Knezovic-Zlataric (A comparison of patient's satisfaction between complete and partial removable denture wearers. J Dent. 2003;21:445-451) and used by Souza et al. (Validation of the Brazilian versions of two inventories for measuring oral health-related quality of life of edentulous subjects. Gerodontology. 2012;29:e88-95.).

    Eight questions were answered according to a three-point scale (0=unsatisfactory; 1=regular; 2=good), whose sum provided a summary satisfaction score that ranged from 0 (the participant is completely dissatisfied with existing dentures) to 16 (maximum satisfaction).

Secondary outcomes

  1. Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis

    Time frame: 30 days

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA).

    Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention.

    All measures were taken according to the vertical, anteroposterior and left-right axes separately.

  2. Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis

    Time frame: 30 days

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA).

    Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention.

    All measures were taken according to the vertical, anteroposterior and left-right axes separately.

  3. Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis

    Time frame: 30 days

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA).

    Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention.

    All measures were taken according to the vertical, anteroposterior and left-right axes separately.

  4. Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis

    Time frame: 30 days

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA).

    Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention.

    All measures were taken according to the vertical, anteroposterior and left-right axes separately.

  5. Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis

    Time frame: 30 days

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA).

    Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention.

    All measures were taken according to the vertical, anteroposterior and left-right axes separately.

  6. Kinesiographic Parameters -- (2.c) Rest Position, Left-right Axis

    Time frame: 30 days

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA).

    Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention.

    All measures were taken according to the vertical, anteroposterior and left-right axes separately.

  7. Kinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis

    Time frame: 30 days

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA).

    Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention.

    All measures were taken according to the vertical, anteroposterior and left-right axes separately.

  8. Kinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis

    Time frame: 30 days

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA).

    Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention.

    All measures were taken according to the vertical, anteroposterior and left-right axes separately.

  9. Kinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis

    Time frame: 30 days

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA).

    Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention.

    All measures were taken according to the vertical, anteroposterior and left-right axes separately.

  10. Kinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis

    Time frame: 30 days

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA).

    Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention.

    All measures were taken according to the vertical, anteroposterior and left-right axes separately.

  11. Kinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis

    Time frame: 30 days

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA).

    Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention.

    All measures were taken according to the vertical, anteroposterior and left-right axes separately.

  12. Kinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis

    Time frame: 30 days

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA).

    Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention.

    All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

A Cross-over Randomized Clinical Trial of Canine Guidance and Bilateral Balanced Occlusion in Complete Denture Wearers

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 19, 2011
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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