Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-01-29 @ 8:28 PM
Study NCT ID:
NCT03221361
Status:
UNKNOWN
Last Update Posted:
2017-07-19
First Post:
2017-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maximum Biting Force of Inject Able Thermoplastic Resin Versus Conventional Resin in Complete Denture Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study will be blinded regarding the statistician who is responsible for data analysis.\n\nThe participant patients will be blinded. The outcome assessor for biting force can be blinded during the measurement, the operator cannot be blinded.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective , parallel , randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2017-07-16', 'studyFirstSubmitQcDate': '2017-07-16', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum biting force', 'timeFrame': '0,2,4,6 months', 'description': 'using gnathodynamometer to compare the difference between maximum biting force'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biting Force']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '1. Brunello DL, Mandikos MN (1998) Construction faults, age, gender, and relative medical health: factors associated with complaints in complete denture patients. J Prosthet Dent 79, 545-554. 2. Craig RG, Powers JM, et al. Restorative Dental Materials. 11th ed. St Louis: Mo, Mosby; 2002. pp. 636-689. 3. O Bricn WJ. Dental Material and their selection. 4th ed. Chicago: Quintessence Publishing Co, Inc.; 2008. pp. 75-113. 4. Marei MK. Reinforcement of denture base resin with glass fillers. J Prosthodont. 1999; 8: 18-26. 5. Vojdani M, Khaledi AAR. Transverse Strength of Reinforced Denture Base Resin with Metal Wire and E-Glass Fibers. J Dent Tehran Univ Med Scien. 2006; 3: 167-172. 6. Vojdani M, Bagheri R, Khaledi AAR. Effects of aluminum oxide addition on the flexural strength, surface hardness, and roughness of heat-polymerized acrylic resin. Journal of Dental Sciences. 2012; 7: 238-244. 7. Matthews E, Smith DC. Nylon as a denture base material. Br Dent J. 1955; 98: 231-237. 8. Negrutiu Meda et al (2005) Thermoplastic resins for flexible framework removable partial dentures. TMJ 55:3 9. Hazari, P., Bhoyar, A., Mishra, S. K., Yadav, N. S., & Mahajan, H. (2015). A Comparison of Masticatory Performance and Efficiency of Complete Dentures Made with High Impact and Flexible Resins: A Pilot Study. Journal of Clinical and Diagnostic Research : JCDR, 9(6), ZC29-34. doi:10.7860/JCDR/2015/12207.6089 10. Rueggeberg FA. From Vulcanite to vinyl, a history of resins in restorative dentistry, J Prosthet Dent. 2002; 87(4):364-79.'}]}, 'descriptionModule': {'briefSummary': 'In this research we are comparing the new thermoplastic material side by side with the conventional poly methyl methacrylate for fully edentulous patients measuring their maximum biting force whether it is going to be higher by the new polyamide material.', 'detailedDescription': "For all included patients and in the first visit, panoramic x ray is taken then a primary impression will be made for the maxillary and mandibular arches using irreversible hydrocolloid material. Then, the maxillary and mandibular impressions will be poured with a hard stone to get a study casts.\n\nA double layer wax spaced self-cured acrylic resin will be used to prepare a special tray for each patient. The special tray using also irreversible hydrocolloid material makes a secondary impression. The secondary impressions will be poured using extra hard dental stone to get the master casts.\n\nAt this point the patient is given a number to enter one of the two groups either the intervention group or the control group.\n\nFor the intervention group, the framework of the thermoplastic resin is usually thicker than that of the metal. At this time the framework wax pattern will be ready for spruing and flasking using specially designed flasks. The injection of the thermoplastic resin will be started after the elimination of wax and the procedure will be done using thermopress machine.\n\nIn the third visit for all patients, the finished denture bases of thermoplastic resin will be tried inside the patient's mouth to check its fitting, retention, reciprocation and opposing occlusion.\n\nThen, a face bow record will be taken for each patient which will be used to mount the maxillary cast on the articulator. For mounting the mandibular cast, either an intercuspal or centric jaw relation will be used. Artificial teeth will be set up and tried in in the patient's mouth in the fourth visit to check esthetics, phonetics, lip support, occlusion and uneven pairing.\n\nIn The fifth visit, the finished prosthesis will be adjusted and delivered to each patient, the outcome data will be collected using a questionnaire, and a salivary swap is taken for microbial count detection.\n\nComplete dentures will be constructed for all patients; Group- I: patients will receive complete dentures from thermoplastic material Group- II: patients will receive complete dentures from conventional Poly methyl Methacrelate resin.\n\nThen use Gnatho-dynamometer for measure the biting force for all patients"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Completely edentulous\n* No bone irregularities\n* Good oral hygiene\n* Should be co-operative\n* Medically free\n* No TMJ Problems\n\nExclusion Criteria:\n\n* \\- Bone irregularities , soft tissue ulcerations , severe undercuts\n* Serious systemic problem\n* Patient with xerostomia\n* Severely resorbed ridge'}, 'identificationModule': {'nctId': 'NCT03221361', 'briefTitle': 'Maximum Biting Force of Inject Able Thermoplastic Resin Versus Conventional Resin in Complete Denture Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Maximum Biting Force of Injectable Thermoplastic Resin Versus Conventional Resin in Complete Denture Patients (A Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '28711170100211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thermoplastic resin group', 'description': 'Thermoplastic complete denture placement is done', 'interventionNames': ['Device: thermoplastic complete denture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'conventional acrylic resin group', 'description': 'conventional acrylic resin complete denture placement is done', 'interventionNames': ['Device: conventional acrylic resin complete denture']}], 'interventions': [{'name': 'thermoplastic complete denture', 'type': 'DEVICE', 'description': 'a device used ti substitute teeth for edentlous patient made of thermoplastic resin', 'armGroupLabels': ['Thermoplastic resin group']}, {'name': 'conventional acrylic resin complete denture', 'type': 'DEVICE', 'description': 'A device used to substitute the teeth for edentlous patient made of acrylic resin', 'armGroupLabels': ['conventional acrylic resin group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amal A Rekaby, Ph.D', 'role': 'CONTACT', 'email': 'ahmed_saad@dentistry.cu.edu.eg', 'phone': '01149977997'}, {'name': 'Mostafa Helmy, Ph.D', 'role': 'CONTACT', 'email': 'ahmed_saad@dentistry.cu.edu.eg', 'phone': '01149977997'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'data will be available through contact by email of the princible investigator ( ahmed\\_saad@dentistry.cu.ed.eg)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Ahmed saad eid', 'investigatorAffiliation': 'Cairo University'}}}}