Edentulous MouthNCT01420536
Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture
A study testing Occlusal scheme in people with Edentulous Mouth and Edentulous Jaw, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Edentulous Mouth, Edentulous Jaw
- What is being tested?
- Occlusal scheme
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Use of cardiac pacemaker
- Refusal to participate or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)
Araraquara, São Paulo, 14801-903
About this study
Official title: A Cross-over Randomized Clinical Trial of Canine Guidance and Bilateral Balanced Occlusion in Complete Denture Wearers
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.
Read the detailed description
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]
- Conditions
- Edentulous Mouth, Edentulous Jaw
- Being tested
- Occlusal scheme
- Keywords
- Bilateral Balanced Occlusion, Canine Guidance, Complete Denture, Denture Retention, Dental Occlusion, Edentulous, Edentulism, Mandibular movement, Mastication, Patient Acceptance of Health Care, Patient Satisfaction
- Medical subject headings
- Mouth, Edentulous, Jaw, Edentulous, Bites and Stings, Patient Acceptance of Health Care, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal schemeProcedure or surgery
Also called Dental articulation, Denture oclusion
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.
| Study group | Role | What they receive |
|---|---|---|
| Canine Guidance | Experimental | Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92) Receives: Procedure: Occlusal scheme |
| Bilateral Balanced Occlusion | Sham comparator | Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions Receives: Procedure: Occlusal scheme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Denture Satisfaction
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).
Measured: 30 days
Secondary outcomes (12)
Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis
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.
Measured: 30 days
Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis
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.
Measured: 30 days
Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis
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.
Measured: 30 days
Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis
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.
Measured: 30 days
Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis
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.
Measured: 30 days
Kinesiographic Parameters -- (2.c) Rest Position, Left-right Axis
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.
Measured: 30 days
Kinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis
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.
Measured: 30 days
Kinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis
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.
Measured: 30 days
Kinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis
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.
Measured: 30 days
Kinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis
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.
Measured: 30 days
Kinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis
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.
Measured: 30 days
Kinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startFeb 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Edentulous MouthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Raphael Freitas de Souza, University of Sao Paulo
- Investigators
- Raphael F de Souza, DDS, PhD, Principal investigator, University of Sao PauloMarco A Compagnoni, DDS, PhD, Study director, Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420536
- Sponsor's protocol ID
- Unesp-PT-001
- Other IDs
- 2008/07183-5, 2008
- Status last verified
- Jan 2021
- First submitted
- 10 Aug 2011
- Last updated
- 26 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Paleari AG, Marra J, Rodriguez LS, de Souza RF, Pero AC, Mollo Fde A Jr, Compagnoni MA. A cross-over randomised clinical trial of eccentric occlusion in complete dentures. J Oral Rehabil. 2012 Aug;39(8):615-22. doi: 10.1111/j.1365-2842.2012.02299.x. Epub 2012 Apr 9.
PubMed 22486470
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-over Randomized Clinical Trial of Canine Guidance and Bilateral Balanced Occlusion in Complete Denture Wearers
- ClinicalTrials.gov ID
- NCT01420536
- Acronym / sponsor ID
- Unesp-PT-001
- Conditions
- Edentulous Mouth, Edentulous Jaw
- Keywords
- Bilateral Balanced Occlusion, Canine Guidance, Complete Denture, Denture Retention, Dental Occlusion, Edentulous, Edentulism, Mandibular movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Posted 26 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canine Guidance | Experimental | Procedure: Occlusal schemeComplete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92) |
| Bilateral Balanced Occlusion | Sham comparator | Procedure: Occlusal schemeComplete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Use of cardiac pacemaker
- Refusal to participate or inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlusal schemeAlso: Dental articulation, Denture oclusionBefore 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. | Procedure or surgery | Bilateral Balanced Occlusion, Canine Guidance |
Primary outcome
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).
12 secondary outcomes
Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis
Time frame: 30 days
Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis
Time frame: 30 days
Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis
Time frame: 30 days
Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis
Time frame: 30 days
Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis
Time frame: 30 days
Kinesiographic Parameters -- (2.c) Rest Position, Left-right Axis
Time frame: 30 days
Kinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis
Time frame: 30 days
Kinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis
Time frame: 30 days
Kinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis
Time frame: 30 days
Kinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis
Time frame: 30 days
Kinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis
Time frame: 30 days
Kinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22486470Paleari AG, Marra J, Rodriguez LS, de Souza RF, Pero AC, Mollo Fde A Jr, Compagnoni MA. A cross-over randomised clinical trial of eccentric occlusion in complete dentures. J Oral Rehabil. 2012 Aug;39(8):615-22. doi: 10.1111/j.1365-2842.2012.02299.x. Epub 2012 Apr 9.
- Institutional page of the Araraquara Dental School (research site)Link provided by the sponsor.
- Institutional page of the Ribeirão Preto Dental School (PI's institution )Link provided by the sponsor.
- Principal Investigator´s CV (RF Souza)Link provided by the sponsor.
- Study director´s CV (MA Compagnoni)Link provided by the sponsor.
Related trials for Edentulous Mouth
Not yet recruiting
Clinical and Radiographic Comparison of Two Implant-Abutment Connections
Dental Implant, Edentulous Alveolar Ridge
RecruitingObservational study
Assessing Current Clinical Concepts in Dental Practice
Dental Implant
Recruiting
Clinical Outcomes of 3D Printed and Milled Complete Dentures
Edentulous Mouth, Edentulous Jaw
RecruitingPhase 4
Clinical Performance of Nobel N1 System
Tooth Loss, Dental Implant
RecruitingObservational study
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Edentulous Mouth, Quality of Life
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael F de Souza, DDS, PhD principal investigator
University of Sao Paulo
Marco A Compagnoni, DDS, PhD study director
Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusal scheme in people with Edentulous Mouth and Edentulous Jaw, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Denture Satisfaction (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01420536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021; AzTrials last refreshed its copy on 26 Oct 2026.