Salivary Markers in Patients With Xerostomia

• Sponsor: Universidad de Murcia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03156569
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Actual Duration (Months): 21
• Patients Per Site: 15
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study was to investigate the salivary levels of inflammatory and their association with oral health in xerostomía patient

Condition or Disease	Intervention/Treatment	Phase
Xerostomia Due to Hyposecretion of Salivary Gland	Diagnostic Test: Analysis of the saliva

Detailed Description

Primary Outcome Measures:

• salivary Proinflammatory and anti-inflammatory cytokines

• questionnaire is provided to the patient for xerostomia characterization

Secondary Outcome Measures:

• Probing pocket depth

• Probing pocket depth and clinical attachment level

• Gingival index

• Plaque index

• Bleeding on probing

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 30 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Oral Health and Salivary Markers in Patients With Xerostomia
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Outcome Measures

Primary Outcome Measures

1. saliva flow rate [2 months]

   Unstimulated salivary flow rate. Pathological < or 1.5 ml/ 15 minutes.

2. Xerostomia [2 months]

   Visual Analogue Scale (VAS) for xerostomia severity (0 cm: no xerostomía , 10cm : very severe xerostomia ).

3. Interleukins [2 months]

   Analytes in saliva IFN-(pg/ml), IL-10(pg/ml), IL-1b(pg/ml), IL-4 (pg/ml)and IL-6 (pg/ml)

Secondary Outcome Measures

1. Oral Exam [4 months]

   Caries number, natural teeth number

2. Periodontal evaluation [4 months]

   periodontal( gingival index, bleeding index, clinical attachment level, probing depth,number dental implant .A periodontal probe will be inserted between the tooth and the gum in the gingival sulcus and a measurement of the pocket depth will be measured by a trained dentist in all subjects according to American Academy of Periodontology classification of periodontal diagnosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• The patient must have clinical symptoms of xerostomia (dry mouth)

Exclusion Criteria:

• Head and neck radiotherapy

• Administration anti-inflammatory drugs or antibiotic therapies within the previous 6 months

• Patients who are unable or unwilling to cooperate

• Patient suffering from cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pia Lopez Jornet	Murcia		Spain	30004
2	Pia Lopez Jornet	Murcia		Spain	30008

Sponsors and Collaborators

• Universidad de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ohyama K, Moriyama M, Hayashida JN, Tanaka A, Maehara T, Ieda S, Furukawa S, Ohta M, Imabayashi Y, Nakamura S. Saliva as a potential tool for diagnosis of dry mouth including Sjögren's syndrome. Oral Dis. 2015 Mar;21(2):224-31. doi: 10.1111/odi.12252. Epub 2014 May 15.

• Responsible Party: Pia Lopez Jornet, MD DDS PhD, Universidad de Murcia
• ClinicalTrials.gov Identifier: NCT03156569
• Other Study ID Numbers: University of Murcia
• First Posted: May 17, 2017
• Last Update Posted: Nov 17, 2017
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pia Lopez Jornet, MD DDS PhD, Universidad de Murcia: saliva , dental , oral health
• Additional relevant MeSH terms: Xerostomia

Study Results

No Results Posted as of Nov 17, 2017