Clinical TrialID 5747
Drug-induced Xerostomia. Evaluation of Malic Acid 1%, Salivary Mucins and Buffering Capacity
NCT01652001
Xerostomia|Depression|Hypertension
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5747
- Evidence Id
- 5747
- Core Evidence Id
- 5747
- Source Clinical Trial Id
- 5731
- Herb2 Clinical Trial Id
- HBCT005731
- Nct Id
- NCT01652001
- Title
- Drug-induced Xerostomia. Evaluation of Malic Acid 1%, Salivary Mucins and Buffering Capacity
- Status
- Completed
- Phase
- Phase 2|Phase 3
- Study Result
- Yes
- Study Condition
- Xerostomia|Depression|Hypertension
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Malic Acid|OTHER: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 185
- Outcome Measure
- Dry Mouth Questionnaire (DMQ), Dry Mouth Questionnaire (DMQ) was used in order to obtain subjective information about the severity of xerostomia before and after treatment with malic acid/placebo. Every participant answered an initial questionnaire (DMQ 1) about the symptoms related to oral dryness, before receiving a spray (1% malic acid or placebo). After two weeks of applications, patients had to answer DMQ 1 again as well as an additional questionnaire (DMQ 2) about the efficacy of the sprays. Increased DMQ scores indicate improvement of xerostomia. DMQ 1 was used to assess the initial severity of oral dryness and in particular its impact on oral function: problems when chewing, swallowing, speaking and general impact on daily life. DMQ 1 used a 0-to-4 rating scale where 0 = "very dry" and 4 = "not dry at all." After two weeks of treatment, DMQ 1 was repeated and it was included DMQ 2. At the end values of DMQ 1 and DMQ 2 were summed, 2 weeks
- Sponsor Collaborator
- Universidad de Granada|Instituto de Salud Carlos III
- Funded By
- OTHER
- Location
- Dental School, Granada, 18071, Spain
- Other Id
- Xerostomia-2012|PI10/00932
- Start Date
- 2011-01
- Primary Completion Date
- 2014-01
- Completion Date
- 2014-01
- First Posted
- 2012-07-27
- Results First Posted
- 2016-04-05
- Last Update Posted
- 2016-04-05
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01652001
- Title Cn
- Title En
- Drug-induced Xerostomia. Evaluation of Malic Acid 1%, Salivary Mucins and Buffering Capacity
- Bilingual Status
- semi_complete