Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2026-01-04 @ 8:40 AM
Study NCT ID:
NCT04207450
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2019-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030242', 'term': 'phosphoric acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-18', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dentin sensitivity', 'timeFrame': 'Immediately after the intervention', 'description': 'Evaluation of pain (dentin sensitivity) by applying tactile (exploratory probe pressure) and evaporative (air blast) stimuli on exposed dentin. Sensitivity will be measured using the Thomas Schiff scale from 0 to 3. Zero means absent dentin sensitivity and three means severe dentin sensitivity.'}], 'secondaryOutcomes': [{'measure': 'Dentin hypersensitivity experience questionnaire', 'timeFrame': 'Immediately after the intervention', 'description': 'A self-reported questionnaire was applied by the patients with the objective of capturing psychosocial experiences, previous treatment and one month after its completion, aiming to evaluate the impact of desensitizing treatment on health-related quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical trials', 'Dentin Sensitivity', 'glutaraldehyde', 'Desensitizing agents'], 'conditions': ['Dentin Sensitivity']}, 'descriptionModule': {'briefSummary': 'This randomized, placebo-controlled, triple-blind trial aims to evaluate the effect of glutaraldehyde associated or not with 37% phosphoric acid conditioning on dentin hypersensitivity reduction after non-surgical periodontal treatment, and its durability after 15 and 30 days. desensitizing treatment. Additionally, investigate the impact of these treatments on health-related quality of life. The investigators selected patients who, after scraping and planing procedures, presented at least 2 teeth meeting the following inclusion criteria: presence of gingival recession without or with a periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile stimulus. and evaporative. Subjects were randomized into 3 groups: Placebo Group (GP) - Placebo Gel application followed by Placebo solution (distilled water); GPG- Placebo Gel application followed by application 5% aqueous glutaraldehyde solution; GSG - Application of 37% phosphoric acid followed by 5% aqueous glutaraldehyde solution. The sensitivity of the dental elements was evaluated by pain stimuli (tactile and evaporative) with the aid of a Visual Analog Scale (VAS). A questionnaire was applied to patients with the objective of capturing psychosocial experiences, prior to treatment and one month after its completion, to assess the impact of desensitizing treatment on health-related quality of life. Data will be collected and appropriate statistical tests will be applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Presence of gingival recession without or with periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile and evaporative stimuli.\n\nExclusion Criteria:\n\n* Systemic diseases;\n* Pulpitis;\n* Carious lesions;\n* Presence of restorations in selected teeth;\n* Cracked enamel;\n* Noncarious cervical lesions;\n* Use of medication with analgesics and/or anti-inflammatories;\n* Pregnant or lactating women;\n* Desensitizing treatment and periodontal treatment received during three months prior to study recruitment.'}, 'identificationModule': {'nctId': 'NCT04207450', 'briefTitle': 'Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Para'}, 'officialTitle': 'Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment: a Triple-blind Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'UFPara-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Placebo Gel + Placebo Solution (Distilled Water)', 'interventionNames': ['Other: Placebo gel']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo Gel + Glutaraldehyde (GPG)', 'description': 'Placebo Gel + 5% Glutaraldehyde Aqueous Solution', 'interventionNames': ['Other: Placebo Gel + 5% Glutaraldehyde Aqueous Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Phosphoric Acid + Glutaraldehyde (GAG)', 'description': '37% Phosphoric Acid + Glutaraldehyde Aqueous Solution (GAG)', 'interventionNames': ['Other: Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%']}], 'interventions': [{'name': 'Placebo gel', 'type': 'OTHER', 'description': 'Placebo gel application followed by placebo solution application (distilled water)', 'armGroupLabels': ['Placebo Group']}, {'name': 'Placebo Gel + 5% Glutaraldehyde Aqueous Solution', 'type': 'OTHER', 'description': 'Placebo gel followed by 5% aqueous glutaraldehyde solution', 'armGroupLabels': ['Placebo Gel + Glutaraldehyde (GPG)']}, {'name': 'Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%', 'type': 'OTHER', 'description': '37% phosphoric acid application followed by 5% aqueous glutaraldehyde solution', 'armGroupLabels': ['Phosphoric Acid + Glutaraldehyde (GAG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66075-110', 'city': 'Belém', 'state': 'Pará', 'country': 'Brazil', 'facility': 'Federal University of Para', 'geoPoint': {'lat': -1.45583, 'lon': -48.50444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Para', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Cecy Martins Silva', 'investigatorAffiliation': 'Universidade Federal do Para'}}}}