| Table
16.1 Randomized Controlled Trial to Evaluate Efficacy of Usual TMD
Clinical Care Plus: 1. Low-Cost Soft Splint vs. 2. Hard, Flat Plane
"Standard Splint" vs. 3. No Splint Control: Clinical Treatment
Protocol Outline
|
|---|
| Week
| Visit
| 1.
Low Cost Soft Splint + Usual Treatment
| 2.
Standard Hard Flat-Plane Splint + Usual Treatment
| 3.
No Splint + Usual Treatment
|
|---|
| 0 | 1 | Enrollment; treatment
as usual begins; wax bite | Enrollment; treatment
as usual begins; impressions for splint | Enrollment; treatment
as usual begins |
| 2 | 2 | Treatment a usual
continues; low cost splint constructed in clinic with patient participation;
instructions provided | Treatment as
usual continues; standard splint fitted, in clinic, with patient participation;
instructions provided | Treatment as
usual continues |
| 6 | 3 | Treatment reviewed
and modified; splint adjusted as needed; untoward events noted | Treatment reviewed
and modified; splint adjusted as needed; untoward events noted | Treatment reviewed
and modified; untoward events noted |
| 10 | 4 | Post-treatment
assessment visit; questionnaire and clinical measures gathered by
blinded study research staff | Post-treatment
assessment visit; questionnaire and clinical measures gathered by
blinded study research staff | Post-treatment
assessment visit; questionnaire and clinical measures gathered by
blinded study research staff |
| 26 | 5 | 6-month follow
up: questionnaire and clinical measures gathered by blinded study
research staff | 6-month follow
up: questionnaire and clinical measures gathered by blinded study
research staff | 6-month follow
up: questionnaire and clinical measures gathered by blinded study
research staff |
| 52 | 6 | 12-month follow
up: questionnaire and clinical measures gathered by blinded study
research staff | 12-month follow
up: questionnaire and clinical measures gathered by blinded study
research staff | 12-month follow
up: questionnaire and clinical measures gathered by blinded study
research staff |
| 78 | 7 | 18-month follow
up: questionnaire and clinical measures gathered by blinded study
research staff | 18-month follow
up: questionnaire and clinical measures gathered by blinded study
research staff | 18-month follow
up: questionnaire and clinical measures gathered by blinded study
research staff |
| 104 | 8 | 24-month follow
up: questionnaire and clinical measures gathered by blinded study
research staff | 24-month follow
up: questionnaire and clinical measures gathered by blinded study
research staff | 24-month follow
up: questionnaire and clinical measures gathered by blinded study
research staff |