Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change from Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24 |
The DHEQ is a condition-specific measure of OHrQoL in relation to DH which contains total 34 questions in section 2, each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 34 to 238, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline. |
Baseline and Weeks 4, 8, 12, 16, 20, 24 |
|
| Primary |
Change from Baseline in DHEQ Restrictions Domain (Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24 |
Restrictions domain in DHEQ evaluates the ways in which any sensations in teeth affect participant's daily life. This contains 4 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 4 to 28, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline. |
Baseline and Weeks 4, 8, 12, 16, 20, 24 |
|
| Primary |
Change from Baseline in DHEQ Adaptation Domain Score (Q5-16) at Weeks 4, 8, 12, 16, 20 and 24 |
Adaptation domain in DHEQ evaluates 'the ways in which the sensations in teeth have forced participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. This contains 12 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 12 to 84, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline. |
Baseline and Weeks 4, 8, 12, 16, 20, 24 |
|
| Primary |
Change from Baseline in DHEQ Social Impact Domain (Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24 |
Social Impact domain in DHEQ evaluates the way the sensations affect participants when they are with other people or in certain situations. This contains 5 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 5 to 35, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline. |
Baseline and Weeks 4, 8, 12, 16, 20, 24 |
|
| Primary |
Change from Baseline in DHEQ Emotional Impact Domain (Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24 |
Emotional Impact Domain in DHEQ evaluates the way the sensations in participant's teeth make them feel. This contains 8 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 8 to 56, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline. |
Baseline and Weeks 4, 8, 12, 16, 20, 24 |
|
| Primary |
Change from Baseline in DHEQ Identity Domain (Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24 |
Identity Domain in DHEQ evaluates what the sensations in participant's teeth mean for them. This contains 5 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 5 to 35, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline. |
Baseline and Weeks 4, 8, 12, 16, 20, 24 |
|
| Secondary |
Change from Baseline in Impact on Everyday Life (Section 1, Q1-3) at Weeks 4, 8, 12, 16, 20 and 24 |
DHEQ section 1 consist of 3 questions about teeth sensation and its impact on everyday life. Participants will score Q1 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q2 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q3 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). The total score for each question ranging from 3 to 30; where lower score indicates less sensitivity and less impact on everyday life. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline. |
Baseline and Weeks 4, 8, 12, 16, 20, 24 |
|
| Secondary |
Change from Baseline in Global Oral Health (Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24 |
Global Oral Health will be evaluated using a single question which asks about overall health of participant's mouth, teeth, and gums. The scale ranges from 1 (excellent) to 6 (Very poor), where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline. |
Baseline and Weeks 4, 8, 12, 16, 20, 24 |
|
| Secondary |
Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24 |
Effect on Life will be evaluated using 4 questions which asks how much the sensations in teeth affect participant's life overall. The scale ranges from 0 (not at all) to 4 (Very much), where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline. |
Baseline and Weeks 4, 8, 12, 16, 20, 24 |
|
| Secondary |
Percentage of Participants who 'Agree' (Score 5-7) With Each Item (statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24 |
The DHEQ consists of 5 domains namely- Restrictions, Adaptation, Social Impact, Emotional Impact and Identity with total 34 questions about the ways in which any sensations in teeth affect participants in their daily life. The scale ranges from 1(strongly disagree) to 7(strongly agree) and scores 5 to 7 indicates agreement with the statement mentioned in the question, where 5=Agree a little, 6=Agree and 7=Strongly agree. |
Baseline and Week 24 |
|
| Secondary |
Change from Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
NPRS is the 11-point segmented numeric version of a Visual Analogue Scale from which the respondent selects the score (0-10) that best reflects the intensity of their pain, where 0=no pain and 10=worst possible pain. Higher scores are indicative of greater pain intensity. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline. |
Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24 |
|
| Secondary |
Satisfaction Numeric Rating Scale (NRS) Score at Week 24 |
Participants will rate their satisfaction with the DH treatment using NRS. It is an 11-point ordinal scale used to assess satisfaction with the overall management of the condition for which the individual sought help from treatment. It ranges from 0 (completely dissatisfied) to 10 (completely satisfied), with higher scores indicative of greater satisfaction. |
Week 24 |
|
| Secondary |
Oral Hygiene Questionnaire (OHQ) Responses at Baseline |
Participants will describe their oral hygiene habits at Baseline by completion of an OHQ. |
Baseline |
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