Trial Outcomes & Findings for Drug-induced Xerostomia. Evaluation of Malic Acid 1%, Salivary Mucins and Buffering Capacity (NCT NCT01652001)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

185 participants

Primary outcome timeframe

2 weeks

Results posted on

2016-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	Malic Acid 1% Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain). Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A. Malic Acid: Oral spray for application into the oral cavity	Control Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid). Placebo: Oral spray for application into the oral cavity
Overall Study STARTED	100	85
Overall Study COMPLETED	91	79
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drug-induced Xerostomia. Evaluation of Malic Acid 1%, Salivary Mucins and Buffering Capacity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Malic Acid 1% n=100 Participants Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain). Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A. Malic Acid: Oral spray for application into the oral cavity	Control n=85 Participants Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid). Placebo: Oral spray for application into the oral cavity	Total n=185 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants	85 Participants n=7 Participants	185 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	55 Participants n=7 Participants	123 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	30 Participants n=7 Participants	62 Participants n=5 Participants
Region of Enrollment Spain	100 participants n=5 Participants	85 participants n=7 Participants	185 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Outcome measures
Measure	Malic Acid 1% n=91 Participants Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain). Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A. Malic Acid: Oral spray for application into the oral cavity	Control n=79 Participants Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid). Placebo: Oral spray for application into the oral cavity
Dry Mouth Questionnaire (DMQ)	3.4 units on a scale Standard Deviation 0.6	1.4 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 2 weeks

Unstimulated and stimulated salivary flow rates were assessed in all patients. The unstimulated salivary flow rate was obtained by the spit method every 30 seconds for 15 minutes. Saliva was collected in 20 mL plastic containers, which were pre-weighted. Stimulated whole saliva was obtained by chewing a 1 g piece of paraffin wax for six minutes. Saliva collected during the first minute was discarded, and then collected into the container every 30 seconds.

Outcome measures

Outcome measures
Measure	Malic Acid 1% n=91 Participants Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain). Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A. Malic Acid: Oral spray for application into the oral cavity	Control n=79 Participants Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid). Placebo: Oral spray for application into the oral cavity
Sialometries Unstimulated Salivary Flow rate	0.17 mL/min Standard Deviation 0.07	0.16 mL/min Standard Deviation 0.09
Sialometries Stimulated Salivary Flow Rate	0.93 mL/min Standard Deviation 0.27	0.75 mL/min Standard Deviation 0.35

Adverse Events

Malic Acid 1%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gómez-Moreno

University of Granada

Phone: +34000000000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place