Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-02-23 @ 2:58 AM
Study NCT ID:
NCT02686632
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2016-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Palatal Brushing on Denture Stomatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013282', 'term': 'Stomatitis, Denture'}, {'id': 'D002180', 'term': 'Candidiasis, Oral'}], 'ancestors': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2016-02-15', 'studyFirstSubmitQcDate': '2016-02-15', 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Candida species colony forming units', 'timeFrame': 'Baseline to 6 months', 'description': 'Palatal saliva (swab) and denture sonicate will be analysed for Candida species CFU count at baseline, 3 months and 6 months. The results will be presented as change in mean CFU count.'}], 'secondaryOutcomes': [{'measure': 'Clinical Inflammation', 'timeFrame': 'Baseline to 6 months', 'description': 'Change in clinical inflammation will be examined and recorded in both groups at baseline, 3 months and 6 months and presented as change in mean inflammation scores.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Denture Stomatitis', 'Denture Erythematous Stomatitis', 'Prosthesis Stomatitis', 'Oral Candidiasis', 'Palatal inflammation'], 'conditions': ['Denture Stomatitis']}, 'referencesModule': {'references': [{'pmid': '20461847', 'type': 'BACKGROUND', 'citation': 'Jainkittivong A, Aneksuk V, Langlais RP. Oral mucosal lesions in denture wearers. Gerodontology. 2010 Mar;27(1):26-32. doi: 10.1111/j.1741-2358.2009.00289.x.'}, {'pmid': '21463383', 'type': 'BACKGROUND', 'citation': 'Gendreau L, Loewy ZG. Epidemiology and etiology of denture stomatitis. J Prosthodont. 2011 Jun;20(4):251-60. doi: 10.1111/j.1532-849X.2011.00698.x. Epub 2011 Apr 4.'}, {'pmid': '25146182', 'type': 'BACKGROUND', 'citation': 'Slade GD, Akinkugbe AA, Sanders AE. Projections of U.S. Edentulism prevalence following 5 decades of decline. J Dent Res. 2014 Oct;93(10):959-65. doi: 10.1177/0022034514546165. Epub 2014 Aug 21.'}, {'pmid': '20305856', 'type': 'BACKGROUND', 'citation': 'de Oliveira CE, Gasparoto TH, Dionisio TJ, Porto VC, Vieira NA, Santos CF, Lara VS. Candida albicans and denture stomatitis: evaluation of its presence in the lesion, prosthesis, and blood. Int J Prosthodont. 2010 Mar-Apr;23(2):158-9.'}, {'pmid': '18434573', 'type': 'BACKGROUND', 'citation': 'Emami E, de Grandmont P, Rompre PH, Barbeau J, Pan S, Feine JS. Favoring trauma as an etiological factor in denture stomatitis. J Dent Res. 2008 May;87(5):440-4. doi: 10.1177/154405910808700505.'}, {'pmid': '15024360', 'type': 'BACKGROUND', 'citation': 'Cross LJ, Williams DW, Sweeney CP, Jackson MS, Lewis MA, Bagg J. Evaluation of the recurrence of denture stomatitis and Candida colonization in a small group of patients who received itraconazole. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Mar;97(3):351-8. doi: 10.1016/j.tripleo.2003.10.006.'}, {'pmid': '28476133', 'type': 'DERIVED', 'citation': 'de Souza RF, Khiyani MF, Chaves CAL, Feine J, Barbeau J, Fuentes R, Borie E, Crizostomo LC, Silva-Lovato CH, Rompre P, Emami E. Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial. Trials. 2017 May 5;18(1):211. doi: 10.1186/s13063-017-1947-y.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25010873', 'label': 'Phase I clinical trial of the proposed study'}]}, 'descriptionModule': {'briefSummary': 'Denture stomatitis (DS) is an oral biofilm associated inflammatory disease of the palatal mucosa. It is the most prevalent oral disease and the main indicator of poor oral health among denture wearers, affecting one-third of all complete denture wearers.\n\nThe etiology of DS is multifactorial, with documented role of mechanical trauma, bacteria and fungi. Risk factors may include, poor oral hygiene and nocturnal use of dentures. However, the evidence is ambiguous, inconclusive and recurrence following routine antifungal therapy is common.\n\nThe proposed study is a phase II clinical trial to evaluate the efficacy of palatal brushing in reducing the colony forming unit (CFU) count and clinical inflammation. The assessment of change in CFU count and clinical inflammation will be carried out at baseline, 3 months and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Wearing a maxillary and mandibular complete conventional denture\n* Having moderate to severe signs of denture stomatitis according to Schwartz index\n* Providing consent prior to study.\n\nExclusion Criteria:\n\n* Oral mucosal lesions other than denture stomatitis.\n* Systemic conditions which predispose to Candida specie infection such as uncontrolled diabetes and xerostomia.\n* History of chemotherapy/radiotherapy.\n* Used antibiotics, steroidal or antifungal agents in the 4 weeks prior to the study.\n* Scheduled to replace existing dentures with new ones during the length of the trial.\n* Already using palatal brushing as a routine oral hygiene procedure.'}, 'identificationModule': {'nctId': 'NCT02686632', 'briefTitle': 'The Effectiveness of Palatal Brushing on Denture Stomatitis', 'organization': {'class': 'OTHER', 'fullName': 'Université de Montréal'}, 'officialTitle': 'Improving Practice Guidelines for the Treatment of Denture-related Erythematous Stomatitis: A Pragmatic International Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FMD-UdeM-EE-2016a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palate Brushing', 'description': 'In this group the intervention is "palatal brushing", performed by the participants following each meal for a period of 6 months. This will be performed using the provided toothbrush (device). The results will determine if brushing the palate in an efficient intervention for reducing the microbial count and inflammation associated with denture stomatitis.', 'interventionNames': ['Behavioral: Palatal brushing']}, {'type': 'NO_INTERVENTION', 'label': 'Regular Oral Hygiene', 'description': 'The participants in this study arm will not be prescribed or allocated any intervention. The participants will be asked to continue with the regular hygiene and denture maintenance practices for the duration of the trial.'}], 'interventions': [{'name': 'Palatal brushing', 'type': 'BEHAVIORAL', 'description': 'Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.', 'armGroupLabels': ['Palate Brushing']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3C3J7', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Université de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Montréal', 'class': 'OTHER'}, 'collaborators': [{'name': 'McGill University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Elham Emami', 'investigatorAffiliation': 'Université de Montréal'}}}}