Trial Outcomes & Findings for Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture (NCT NCT01420536)

NCT ID: NCT01420536

Last Updated: 2021-01-26

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

30 days

Results posted on

2021-01-26

Participant Flow

Recruitment period: July to December 2012. Convenience sample composed by 50 patients, who had volunteered to receive new complete dentures at Araraquara Dental School - UNESP.

Participants waited 30 days following the completion of treatment, in order to have them functionally adapted to their new dentures. Six spontaneously declined to participate before random assignment due to lack of interest.

Participant milestones

Participant milestones
Measure
Canine Guidance, Then Bilateral Balanced Occlusion
Canine guidance: 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); Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Bilateral Balanced Occlusion, Then Canine Guidance
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions; Canine guidance: 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).
Period 1 (30 Days)
STARTED
22
22
Period 1 (30 Days)
COMPLETED
19
22
Period 1 (30 Days)
NOT COMPLETED
3
0
Period 2 (30 Days)
STARTED
19
22
Period 2 (30 Days)
COMPLETED
19
22
Period 2 (30 Days)
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Canine Guidance, Then Bilateral Balanced Occlusion
Canine guidance: 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); Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Bilateral Balanced Occlusion, Then Canine Guidance
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions; Canine guidance: 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).
Period 1 (30 Days)
Withdrawal by Subject
3
0

Baseline Characteristics

Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Canine Guidance, Then Bilateral Balanced Occlusion
n=22 Participants
Canine guidance: 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); Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Bilateral Balanced Occlusion Then Canine Guidance
n=22 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions; Canine guidance: 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);
Total
n=44 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=99 Participants
11 Participants
n=107 Participants
22 Participants
n=206 Participants
Age, Categorical
>=65 years
11 Participants
n=99 Participants
11 Participants
n=107 Participants
22 Participants
n=206 Participants
Age, Continuous
65.5 years
STANDARD_DEVIATION 10.6 • n=99 Participants
66.4 years
STANDARD_DEVIATION 10.3 • n=107 Participants
66.0 years
STANDARD_DEVIATION 10.5 • n=206 Participants
Sex: Female, Male
Female
14 Participants
n=99 Participants
14 Participants
n=107 Participants
28 Participants
n=206 Participants
Sex: Female, Male
Male
8 Participants
n=99 Participants
8 Participants
n=107 Participants
16 Participants
n=206 Participants
Region of Enrollment
Brazil
22 participants
n=99 Participants
22 participants
n=107 Participants
44 participants
n=206 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Convenience sampling.

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).

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Denture Satisfaction
15 units on a scale
Interval 12.0 to 16.0
15 units on a scale
Interval 12.0 to 16.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis
30.3 mm
Standard Deviation 4.5
30.9 mm
Standard Deviation 4.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis
25.1 mm
Standard Deviation 9.4
25.8 mm
Standard Deviation 8.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis
1.4 mm
Standard Deviation 1.3
1.7 mm
Standard Deviation 2.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis
2.1 mm
Standard Deviation 1.2
2.3 mm
Standard Deviation 1.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis
1.9 mm
Standard Deviation 1.0
1.9 mm
Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Kinesiographic Parameters -- (2.c) Rest Position, Left-right Axis
0.5 mm
Standard Deviation 0.5
0.4 mm
Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Kinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis
12.0 mm
Standard Deviation 2.7
12.1 mm
Standard Deviation 2.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Kinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis
4.2 mm
Standard Deviation 2.1
4.3 mm
Standard Deviation 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Kinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis
1.2 mm
Standard Deviation 2.1
1.3 mm
Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Kinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis
-0.5 mm
Standard Deviation 0.4
-0.6 mm
Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Kinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis
-0.4 mm
Standard Deviation 0.7
-0.4 mm
Standard Deviation 0.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Canine Guidance
n=39 Participants
Canine guidance: 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)
Bilateral Balanced Occlusion
n=39 Participants
Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Kinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis
-0.1 mm
Standard Deviation 0.5
-0.1 mm
Standard Deviation 0.3

Adverse Events

Canine Guidance

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Bilateral Balanced Occlusion

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Marco Antonio Compagnoni

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

Phone: +55-16-3331-6411

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place