Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-17 @ 10:26 PM
Study NCT ID:
NCT03234803
Status:
UNKNOWN
Last Update Posted:
2017-07-31
First Post:
2017-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Quality of Life of Poly-amide Complete Dentures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009757', 'term': 'Nylons'}, {'id': 'D019904', 'term': 'Polymethyl Methacrylate'}], 'ancestors': [{'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D008768', 'term': 'Methylmethacrylates'}, {'id': 'D011109', 'term': 'Polymethacrylic Acids'}, {'id': 'D000179', 'term': 'Acrylates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000180', 'term': 'Acrylic Resins'}, {'id': 'D012117', 'term': 'Resins, Synthetic'}]}}, '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': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-27', 'studyFirstSubmitDate': '2017-07-27', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oral health related quality of life', 'timeFrame': 'one month', 'description': 'OHIP-49 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Denture, Complete']}, 'referencesModule': {'references': [{'pmid': '18761582', 'type': 'BACKGROUND', 'citation': 'Ali IL, Yunus N, Abu-Hassan MI. Hardness, flexural strength, and flexural modulus comparisons of three differently cured denture base systems. J Prosthodont. 2008 Oct;17(7):545-9. doi: 10.1111/j.1532-849X.2008.00357.x. Epub 2008 Aug 26.'}, {'pmid': '23719015', 'type': 'BACKGROUND', 'citation': 'Wadachi J, Sato M, Igarashi Y. Evaluation of the rigidity of dentures made of injection-molded materials. Dent Mater J. 2013;32(3):508-11. doi: 10.4012/dmj.2013-061.'}, {'pmid': '24905261', 'type': 'BACKGROUND', 'citation': 'Schwindling FS, Rammelsberg P, Stober T. Effect of chemical disinfection on the surface roughness of hard denture base materials: a systematic literature review. Int J Prosthodont. 2014 May-Jun;27(3):215-25. doi: 10.11607/ijp.3759.'}]}, 'descriptionModule': {'briefSummary': "Polymethyl methacrylate have been used since 1937 as a gold standard for a denture base material because of its several advantages as; good esthetics, adequate strength, easy repair and simple processing techniques. As any material it has some problems as polymerization shrinkage, low impact and flexural properties and low fatigue resistance2. So polyamide was introduced into dentistry to be used as a denture base material in order to solve these problems. Polyamide denture base materials have some superior properties than PMMA as; High impact \\& flexural strength, excellent esthetics and less release of residual monomers4. Although being an advantage from the point of patient satisfaction, flexural property considered to be a contraindication for a denture base material.\n\nThe invistigators' trial is done in order to improve rigidity of a polyamide material as well as to improve oral health related quality of life in comparison to heat cured polymethyl methacrylate."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- i. Male or female patient with age range (45-55) and in good medical condition ii. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient inter-arch distance.\n\niii. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.\n\niv. Free from any tempro-mandibular joint disorder. v. The patients have good oral hygiene.\n\nExclusion Criteria:\n\n\\- i. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.\n\nii. Patient with xerostomia or excessive salivation. iii. Patient with abnormal tongue behavior and/or size. iv. No intraoral soft and hard tissue pathosis"}, 'identificationModule': {'nctId': 'NCT03234803', 'briefTitle': 'Measuring Quality of Life of Poly-amide Complete Dentures', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Metal-reinforced Flexible Poly-amide Complete Denture Versus Heat-cured Poly-methyl Methacrylate in Terms of Oral Health Related Quality of Life; Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'polyamide_complete dentures'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'poly-amide', 'description': 'poly-amide is a thermoplastic material recently introduced to be used as a complete denture material, that provide excellent aesthetics and flexibility.', 'interventionNames': ['Other: poly-amide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'poly-methyl methacrylate', 'description': 'poly-methyl methacrylate has been commonly used as a material for constructing complete dentures and proved to have high success rate and considered to be gold standard.', 'interventionNames': ['Other: poly-methyl methacrylate']}], 'interventions': [{'name': 'poly-amide', 'type': 'OTHER', 'otherNames': ['Nylon'], 'description': 'new denture base material', 'armGroupLabels': ['poly-amide']}, {'name': 'poly-methyl methacrylate', 'type': 'OTHER', 'description': 'gold standard for denture base materials', 'armGroupLabels': ['poly-methyl methacrylate']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amr Nasr, DDS', 'role': 'CONTACT', 'email': 'denamr12@gmail.com', 'phone': '01285247060'}, {'name': 'Maha El Kerdawy', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Internal resident at removable prosthodontic department', 'investigatorFullName': 'Amr Magdy Ibrahim', 'investigatorAffiliation': 'Cairo University'}}}}