Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 3:16 AM
Study NCT ID:
NCT07063433
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Gluma and Bioactive Glass Desensitizers in Treatment of Dentin Hypersensitivity in Cervical Non-Carious Lesions
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': 'C111486', 'term': 'gluma desensitizer'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative hypersensitivity assessment using Visaul', 'timeFrame': 'From enrollment to the end of treatment at 6 months .', 'description': 'Post-operative hypersensitivity assessment will be conducted immediately after application, as well as at three months and six months post-treatment. The evaluation will utilize the Visual Analog Scale (VAS) as described by Van den Breemer et al. (2019) . This scale is represented by a horizontal line graded from 1 to 10, with a descriptor at its far-left end indicating no pain and at its far-right end indicating the worst possible pain. Additionally, facial expressions with color codes will be illustrated below the 10-centimeter line on the Visual Analog Scale, as outlined by Burrow et al. (2009). This approach provides a comprehensive and visual means for patients to express and quantify their post-operative hypersensitivity levels.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dentin hypersensitivity', 'gluma', 'Bioactive glass', 'fluoride varnish', 'VAS', 'non carious lesions', 'cervical non carious lesions'], 'conditions': ['Dentin Hypersensitivity']}, 'descriptionModule': {'briefSummary': "Type of study: (A Randomized Controlled Clinical Trial)\n\nAim :The aim of this randomized controlled clinical trial is to evaluate the effect of Gluma, Bioactive Glass and combination of both, compared to Flouride Varnish on the treatment of dentin hypersensitivity of cervical non-carious lesions in adult Population over six months.\n\nThe study will enroll 40 patients meeting the inclusion criteria. Each patient will contribute one tooth with complaints that meet the inclusion criteria, resulting in a total of 40 included teeth. The teeth will be categorized into Four groups based on the type of desensitizer used.\n\n* Group 1 (G1); patients will be randomly assigned to Gluma.\n* Group 2 (G2); patients will be randomly assigned to Bioactive Glass Powder.\n* Group 3 (G3); patients will be randomly assigned to combination of both materials, Gluma and Bioactive Glass powder\n* Group 4 (G4); patients will be randomly assigned to the Fluoride Varnish. For each patient, a sensitivity test will be conducted using a Visual Analog Scale immediately after desensitizer application, as well as at three months and six months post-application.\n\nClinical procedures:\n\nThe study will involve applying a controlled air stimulus (evaporative) to the complaining tooth. This will be done using a dental syringe adjusted to 40-65 psi, directed perpendicular at a distance of 1-3 mm from the exposed dentin. Subsequently, the patient will indicate the level of sensitivity on a Visual Analog Scale (VAS) chart ranging from 0 to 10, with a focus on instances where the VAS score exceeds 4. To facilitate the patient's expression of pain intensity, a plastic card featuring figures with facial expressions, color-coded, and numbered, will be utilized. This visual aid aims to streamline the process of discerning and recording the degree of pain experienced by the patient.\n\nFor Gluma group\n\nEach sensitive tooth will be cleaned with a polishing paste, rinsed with water and air dried. Two coats of Gluma Desensitizer will be applied using a disposable brush applicator following the manufacturer's instructions and left untouched for 30-60 minutes.\n\nFor Bioactive Glass group :\n\nTo maintain a dry and clear field of vision, cheek retractors and high-volume suction will be employed during the procedure. High-volume suction, featuring a 45-degree beveled end, will be strategically positioned at the incisal or occlusal part of the teeth. This placement is designed to efficiently remove any particles, preventing the patient from swallowing them and minimizing the risk of minor injuries resulting from a forceful powder and water stream. The NSK Prophymate Neo will be utilized to dispense Sylc dry powder, which comprises calcium sodium phosphosilicate, onto the sensitive areas. The air stream will be carefully adjusted to 40-46 psi in accordance with the manufacturer's instructions. The handpiece will be maintained at a constant distance of 3-4 mm from the tooth surface, positioned at 60-80 degrees on the buccal surfaces. To prevent gingival injury, the tip of the handpiece will be directed incisally during application. The powder will be applied for 5-10 seconds per tooth, using a circular motion.\n\nFor the combined group (Bioactive Glass + Gluma) A combination of both Gluma and bioactive glass powder will be applied to the assigned teeth.\n\nFor the comparator group :\n\nThe teeth will undergo a thorough cleaning process using a polishing brush without any paste, and the surfaces will be subsequently air-dried. The application of a single dose of Bifluorid 10 (by VOCO) will be carried out using a micro brush. A thin coat of varnish will be applied to the tooth surface, and it will be left in place for 10-20 seconds before being air-dried. This procedure is designed to facilitate the effective application of the desensitizing agent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient's age ranges from 21- 40 years old.\n2. Males or Females\n3. Co-operative Patients approving the trial.\n4. Good oral hygiene\n5. Not received antibiotic therapy for 1 month before sampling\n\nExclusion Criteria:\n\n1. Lack of compliance\n2. Patients with bad oral hygiene\n3. Patients who are allergic to any ingredients used in the study.\n4. Medically compromised patients with systemic complications that would alter the treatment.\n5. Patients who did any periodontal surgeries within the previous 6 months.\n6. Inability to give informed consent.\n7. Xerostomia.\n8. Pregnancy"}, 'identificationModule': {'nctId': 'NCT07063433', 'briefTitle': 'Effect of Gluma and Bioactive Glass Desensitizers in Treatment of Dentin Hypersensitivity in Cervical Non-Carious Lesions', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'The Effect of Gluma and Bioactive Glass in Treatment of Dentin Hypersensitivity in Cervical Lesions (A Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '24-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gluma Group', 'description': "Each sensitive tooth will be cleaned with a polishing paste, rinsed with water and air dried. Two coats of Gluma Desensitizer will be applied using a disposable brush applicator following the manufacturer's instructions and left untouched for 30-60 minutes.", 'interventionNames': ['Drug: Gluma Desensitizer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bioactive Glass Group', 'description': "To maintain a dry and clear field of vision, cheek retractors and high-volume suction will be employed during the procedure. High-volume suction, featuring a 45-degree beveled end, will be strategically positioned at the incisal or occlusal part of the teeth. This placement is designed to efficiently remove any particles, preventing the patient from swallowing them and minimizing the risk of minor injuries resulting from a forceful powder and water stream. The NSK Prophymate Neo will be utilized to dispense Sylc dry powder, which comprises calcium sodium phosphosilicate, onto the sensitive areas. The air stream will be carefully adjusted to 40-46 psi in accordance with the manufacturer's instructions. The handpiece will be maintained at a constant distance of 3-4 mm from the tooth surface, positioned at 60-80 degrees on the buccal surfaces. To prevent gingival injury, the tip of the handpiece will be directed incisally during application. The powder will be applied for 5-10 seconds pe", 'interventionNames': ['Drug: Bioactive glass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combination of Gluma and Bioactive glass', 'description': 'A combination of both Gluma and bioactive glass powder will be applied to the assigned teeth.', 'interventionNames': ['Drug: Gluma Desensitizer', 'Drug: Bioactive glass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoride Varnish', 'description': 'The teeth will undergo a thorough cleaning process using a polishing brush without any paste, and the surfaces will be subsequently air-dried. The application of a single dose of Bifluorid 10 (by VOCO) will be carried out using a micro brush. A thin coat of varnish will be applied to the tooth surface, and it will be left in place for 10-20 seconds before being air-dried. This procedure is designed to facilitate the effective application of the desensitizing agent.', 'interventionNames': ['Drug: Fluoride varnish']}], 'interventions': [{'name': 'Gluma Desensitizer', 'type': 'DRUG', 'description': "Each sensitive tooth will be cleaned with a polishing paste, rinsed with water and air dried. Two coats of Gluma Desensitizer will be applied using a disposable brush applicator following the manufacturer's instructions and left untouched for 30-60 minutes.", 'armGroupLabels': ['Combination of Gluma and Bioactive glass', 'Gluma Group']}, {'name': 'Bioactive glass', 'type': 'DRUG', 'otherNames': ['Sylc'], 'description': "The NSK Prophymate Neo will be utilized to dispense Sylc dry powder, which comprises calcium sodium phosphosilicate, onto the sensitive areas. The air stream will be carefully adjusted to 40-46 psi in accordance with the manufacturer's instructions. The handpiece will be maintained at a constant distance of 3-4 mm from the tooth surface, positioned at 60-80 degrees on the buccal surfaces. The powder will be applied for 5-10 seconds per tooth, using a circular motion.", 'armGroupLabels': ['Bioactive Glass Group', 'Combination of Gluma and Bioactive glass']}, {'name': 'Fluoride varnish', 'type': 'DRUG', 'otherNames': ['Bifluorid 10'], 'description': 'The application of a single dose of Bifluorid 10 (by VOCO) will be carried out using a micro brush. A thin coat of varnish will be applied to the tooth surface, and it will be left in place for 10-20 seconds before being air-dried.', 'armGroupLabels': ['Fluoride Varnish']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4914085', 'city': 'Cairo', 'state': 'Elshorouk City', 'country': 'Egypt', 'facility': 'The British University in Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sara Katarya', 'investigatorAffiliation': 'British University In Egypt'}}}}