Trial Outcomes & Findings for Effects of Mouth-opening Training on the Maximum Interincisal Opening (NCT NCT03875118)
NCT ID: NCT03875118
Last Updated: 2021-04-27
Results Overview
The TheraBite® Range-of-Motion Scale was used to measure the maximum incisal opening (MIO), which is the maximal vertical distance between the edges of the incisors of the maxilla and the mandible. The TheraBite® Range-of-Motion Scale is a disposable paper measuring scale specially designed to measure a subject's mouth and jaw opening. The subject sits in an upright position with his mouth open wide. For measuring the vertical opening, the scale has a possible range of 5 to 70 mm, with the notch is placed on the lower incisor midline. The usual range of MIO is between 40 and 55 mm. Subjects with MIO \<35 mm are considered to have trismus.
COMPLETED
NA
68 participants
Change from Baseline to 3 months
2021-04-27
Participant Flow
Patients admitted to the hospital for curative oral cancer surgeries were recruited from surgical units of are going a teaching hospital in southernTaiwan. Potential subjects were referred by physicians and then screened by one of the researchers to determine their eligibility.
72 people didn't meet inclusion criteria and 6 people decline to the study.
Participant milestones
| Measure |
Mouth-opening Training With Follow-up Calls
Subjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
The mouth-opening training with follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
|
Mouth-opening Training Without Follow-up Calls
Subjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
The mouth-opening training without follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Mouth-opening Training With Follow-up Calls
Subjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
The mouth-opening training with follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
|
Mouth-opening Training Without Follow-up Calls
Subjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
The mouth-opening training without follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
Baseline Characteristics
Effects of Mouth-opening Training on the Maximum Interincisal Opening
Baseline characteristics by cohort
| Measure |
Mouth-opening Training With Follow-up Calls
n=30 Participants
Subjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
The mouth-opening training with follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
|
Mouth-opening Training Without Follow-up Calls
n=30 Participants
Subjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
The mouth-opening training without follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
|
Total
n=60 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
|
22 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 3 monthsThe TheraBite® Range-of-Motion Scale was used to measure the maximum incisal opening (MIO), which is the maximal vertical distance between the edges of the incisors of the maxilla and the mandible. The TheraBite® Range-of-Motion Scale is a disposable paper measuring scale specially designed to measure a subject's mouth and jaw opening. The subject sits in an upright position with his mouth open wide. For measuring the vertical opening, the scale has a possible range of 5 to 70 mm, with the notch is placed on the lower incisor midline. The usual range of MIO is between 40 and 55 mm. Subjects with MIO \<35 mm are considered to have trismus.
Outcome measures
| Measure |
Mouth-opening Training With Follow-up Calls
n=30 Participants
Subjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
The mouth-opening training with follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
|
Mouth-opening Training Without Follow-up Calls
n=30 Participants
Subjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
The mouth-opening training without follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
|
|---|---|---|
|
TheraBite Range-of-Motion Scale
Baseline
|
27.43 units on a scale
Standard Deviation 10.71
|
26.57 units on a scale
Standard Deviation 10.53
|
|
TheraBite Range-of-Motion Scale
3 month later
|
27.33 units on a scale
Standard Deviation 9.73
|
16.17 units on a scale
Standard Deviation 8.01
|
SECONDARY outcome
Timeframe: Change from Baseline to 3 monthsThe MFIQ (Mandibular Function Impairment Questionnaire) was used to measure the extent of patients' mandibular function impairment. The questionnaire consists of 17 items, each of which targets a specific oral function impairment; including difficulties in social activity, speech, taking a large bite, chewing hard food, chewing soft food, work and/or daily activities, drinking, laughing, chewing resistant food, yawning, kissing, and eating different types of food. The subjects were asked to indicate how much difficulty they had with each activity or with eating each type of food using a 5-point Likert scale (0 = no difficulty, 4 = very difficult or impossible without help). The total score of the 17 items divided by 68 provides the scale score, with a possible range of 0 to 1. A higher score indicates greater severity of the mandibular function impairment. A score ≤ 0.3, between 0.3 and 0.6, and \>0.6 indicates mild, moderate, and severe mandibular function impairment, respectively.
Outcome measures
| Measure |
Mouth-opening Training With Follow-up Calls
n=30 Participants
Subjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
The mouth-opening training with follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
|
Mouth-opening Training Without Follow-up Calls
n=30 Participants
Subjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
The mouth-opening training without follow-up telephone calls program: Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
|
|---|---|---|
|
Mandibular Function Impairment Questionnaire (MFIQ)
Baseline
|
0.16 score on a scale
Standard Deviation 0.21
|
0.17 score on a scale
Standard Deviation 0.20
|
|
Mandibular Function Impairment Questionnaire (MFIQ)
3 month later
|
0.18 score on a scale
Standard Deviation 0.23
|
0.55 score on a scale
Standard Deviation 0.30
|
Adverse Events
The Intervention Group
The Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Nursing Department
National Taipei University of Nursing Health and Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place