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).
COMPLETED
NA
44 participants
30 days
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
| 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
| 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
| 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 daysPopulation: 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
| 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 daysMandibular 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
| 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 daysMandibular 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
| 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 daysMandibular 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
| 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 daysMandibular 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
| 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 daysMandibular 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
| 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 daysMandibular 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
| 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 daysMandibular 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
| 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 daysMandibular 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
| 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 daysMandibular 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
| 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 daysMandibular 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
| 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 daysMandibular 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
| 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 daysMandibular 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
| 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
Bilateral Balanced Occlusion
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)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place