Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2026-01-01 @ 3:19 PM
Study NCT ID:
NCT04875468
Status:
UNKNOWN
Last Update Posted:
2021-05-25
First Post:
2021-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Bonded Monolithic Translucent Zirconia Crowns Using Two Different Compositions of Self-adhesive Resin Cements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D014075', 'term': 'Tooth Discoloration'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-21', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-05-01', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal discoloration', 'timeFrame': '9 months', 'description': 'Alpha (A): no discoloration (There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacement.\n\n(visual inspection)\n\nBravo (B): discoloration without axial penetration (There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction.\n\n(visual inspection)\n\nCharlie (C): discoloration with axial penetration (There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction. (visual inspection'}], 'secondaryOutcomes': [{'measure': 'Marginal Adaptation', 'timeFrame': '9 months', 'description': 'Alpha (A) No visible evidences of crevice along the margins; no catch or penetration of the explorer.\n\nBravo (B) Visible evidence of crevice and/or catch of explorer; no penetration of the explorer.\n\nCharlie (C) Visible evidence of crevice and penetration of explorer'}, {'measure': 'Patient satisfaction', 'timeFrame': '9 months', 'description': 'Numerical (discrete) ("0" unsatisfied - "10" satisfied)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Marginal adaptation, patient satisfaction'], 'conditions': ['Destructed Teeth Restored by Zirconia Crowns', 'Zirconia Crowns', 'Decayed, Missing, and Filled Teeth', 'Tooth Discoloration']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the clinical outcomes (marginal discoloration, marginal adaptation, gingival health, debonding and patient satisfaction) of translucent zirconia crowns bonded by TheraCem (MDP, calcium and fluoride releasing) self-adhesive resin cement compared to multilink self-adhesive resin cement.', 'detailedDescription': 'Clinical outcomes of bonded monolithic translucent zirconia crowns using two different compositions of self-adhesive resin cements (Randomized Clinical Trial)\n\nResearch question:\n\nWill TheraCem self-adhesive resin cement (MDP, calcium and fluoride releasing cement) give better outcomes when bonding monolithic translucent zirconia crowns to tooth structure compared to Multilink self-adhesive resin cement (non MDP, non-calcium and fluoride releasing cement) in terms of marginal discoloration, marginal adaptation, gingival health, debonding and patient satisfaction?\n\nPICOS:\n\nP: Population: Patients requiring single zirconia crowns I: Intervention: TheraCem self-adhesive resin cement (MDP, calcium and fluoride releasing cement) C: Comparison: Multilink adhesive resin cement (non MDP, non-calcium and fluoride releasing cement)\n\nO: Outcomes:\n\nOutcomes Primary outcome Marginal discoloration using USPHS for 9 months Secondary outcomes 1. Marginal adaptation\n\n2\\. patient satisfaction\n\nStatement of the problem:\n\nBonding of zirconia restorations to tooth structures is still challenging. The success of the restoration may be affected by the type of cement used as it may affect marginal discoloration, marginal adaptation, gingival health, debonding and patient satisfaction. The effect of newly introduced TheraCem self-adhesive resin cement (MDP, calcium and fluoride releasing cement) on the clinical behavior of bonded translucent monolithic zirconia is not yet fully reported.\n\nAim of the study:\n\n\\- The aim of the present study is to evaluate the clinical outcomes (marginal discoloration, marginal adaptation and patient satisfaction) of translucent zirconia crowns bonded by TheraCem (MDP, calcium and fluoride releasing) self-adhesive resin cement compared to multilink self-adhesive resin cement.\n\nResearch null hypothesis:\n\n-There will be no difference in color stability, marginal adaptation and patient satisfaction of translucent zirconia crowns bonded either with TheraCem or Multilink self-adhesive resin cements.\n\nPrimary objective:\n\nThe Primary outcome: Marginal discoloration using USPHS Secondary outcomes: 1. Marginal adaptation 2. Patient satisfaction\n\nTrial design:\n\nParallel group, two arms, with 1:1 ratio\n\nMethods:\n\nA) Participants, interventions, and outcomes\n\nStudy setting: This study will be carried out on patients enrolled from the Outpatient clinic in fixed prosthodontics clinic, Faculty of Dentistry, Cairo University.\n\nEligibility criteria:\n\nInclusion criteria:\n\nAll subjects are required to be:\n\n1. From 18-50 years old, be able to read and sign the informed consent document.\n2. Have no active periodontal or pulpal diseases, have teeth with good restorations\n3. Psychologically and physically able to withstand conventional dental procedures\n4. Patients with teeth problems indicated for single crowns:\n\n 1. Badly decayed teeth\n 2. Teeth restored with large filling restorations\n 3. Endodontically treated teeth\n 4. Malformed teeth\n 5. Malposed teeth (Tilted, over-erupted, rotated, etc.)\n 6. Spacing between teeth\n5. Able to return for follow-up examinations and evaluation.\n\nExclusion criteria:\n\n1. Patient less than 18 or more than 50 years\n2. Patient with active resistant periodontal disease\n3. Patients with poor oral hygiene and uncooperative patients\n4. Pregnant women\n5. Patients in the growth stage with partially erupted teeth\n6. Psychiatric problems or unrealistic expectations\n\nInterventions:\n\nTheraCem (MDP containing - calcium and fluoride releasing self-adhesive resin cement).\n\nOutcomes The outcomes will be assessed at the following time points\n\nT0 = immediately after restoration delivery\n\nPrimary Marginal Discoloration Alpha (A): no discoloration (There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacement.\n\n(visual inspection)\n\nBravo (B): discoloration without axial penetration (There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction.\n\n(visual inspection)\n\nCharlie (C): discoloration with axial penetration (There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction. (visual inspection Secondary 1.Marginal Adaptation Alpha (A) No visible evidences of crevice along the margins; no catch or penetration of the explorer.\n\nBravo (B) Visible evidence of crevice and/or catch of explorer; no penetration of the explorer.\n\nCharlie (C) Visible evidence of crevice and penetration of explorer 2.Patient satisfaction Numerical (discrete) ("0" unsatisfied - "10" satisfied)\n\nParticipant timeline:\n\n\\- The patient will be treated in visits designated as follows:\n\nVisit 1: Pre-operative records, face-to-face adherence reminder session, clinical, radiographic examination, intraoral photographs and primary impression (alginate impression\\*) for diagnostic cast construction.\n\nVisit 2: Teeth preparation, secondary impression using addition silicone rubber base material†and temporary restoration‡.\n\nVisit 3: Try in Visit 4: placement and permanent cementation of the final restoration.\n\n\\* Marginal discoloration, color stability, marginal adaptation and patient satisfaction will be evaluated immediately after cementation.\n\nRecall visits:\n\nThe same evaluators evaluated the participants during the recall appointments with a mirror and a sharp explorer at 3 months, 6 months, and 9 months. Periapical radiographs were made and postoperative data were collected and used as a documentation tool with the clinical photographs. Marginal adaptation, esthetics, patient satisfaction and clinical examination were assessed using USPH After delivering the crowns, the participants were asked to rate the level of the satisfaction with their restorations by using a 1 to 10 numeric rating scale (1=poor, 5=acceptable, 10=excellent) at 3 months, 6 months and 9 months. Mean, standard deviation and 95% confidence interval for the mean were used to summarize patient satisfaction.\n\nData collection methods:\n\nPrimary outcome: Marginal discoloration will be assessed by using HSPHS criteria Secondary outcomes: 1. Marginal adaptation will be assessed using the modified USPHS criteria.\n\n2\\. Patient satisfaction will be assessed by using normal scores numerical score from 1 to 10 (1=poor, 5=acceptable, 10=excellent)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects are required to be:\n\n 1. From 18-50 years old, be able to read and sign the informed consent document.\n 2. Have no active periodontal or pulpal diseases, have teeth with good restorations\n 3. Psychologically and physically able to withstand conventional dental procedures\n 4. Patients with teeth problems indicated for single crowns:\n\n 1. Badly decayed teeth\n 2. Teeth restored with large filling restorations\n 3. Endodontically treated teeth\n 4. Malformed teeth\n 5. Malposed teeth (Tilted, over-erupted, rotated, etc.)\n 6. Spacing between teeth\n 5. Able to return for follow-up examinations and evaluation.\n\nExclusion Criteria:\n\n* 1\\. Patient less than 18 or more than 50 years 2. Patient with active resistant periodontal disease 3. Patients with poor oral hygiene and uncooperative patients 4. Pregnant women 5. Patients in the growth stage with partially erupted teeth 6. Psychiatric problems or unrealistic expectations'}, 'identificationModule': {'nctId': 'NCT04875468', 'briefTitle': 'Clinical Outcomes of Bonded Monolithic Translucent Zirconia Crowns Using Two Different Compositions of Self-adhesive Resin Cements', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Outcomes of Bonded Monolithic Translucent Zirconia Crowns Using Two Different Compositions of Self-adhesive Resin Cements (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '28611222102086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Zirconia crown cemented by adhesive resin cement', 'description': 'MultiRein link adhesive resin cement (non MDP, non-calcium and fluoride releasing cement)', 'interventionNames': ['Other: Multilink adhesive resin cement']}, {'type': 'EXPERIMENTAL', 'label': 'Zirconia crown cemented by self-adhesive resin cement', 'description': 'TheraCem self-adhesive resin cement (MDP, calcium and fluoride releasing cement)', 'interventionNames': ['Other: TheraCem self-adhesive resin cement']}], 'interventions': [{'name': 'TheraCem self-adhesive resin cement', 'type': 'OTHER', 'description': 'MDP, calcium and fluoride releasing cement for dental zirconia crowns', 'armGroupLabels': ['Zirconia crown cemented by self-adhesive resin cement']}, {'name': 'Multilink adhesive resin cement', 'type': 'OTHER', 'description': '(non MDP, non-calcium and fluoride releasing cement)', 'armGroupLabels': ['Zirconia crown cemented by adhesive resin cement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Diana Mostafa Habeb', 'role': 'CONTACT', 'email': 'diana.mustafa@dentistry.cu.edu.eg', 'phone': '+20109643699'}], 'facility': 'Faculty of Dentistry Cairo University'}], 'centralContacts': [{'name': 'Diana Mostafa Habeb, Msc of fixed Prosthodontics', 'role': 'CONTACT', 'email': 'diana.mustafa@dentistry.cu.edu.eg', 'phone': '+201096643699'}, {'name': 'Ashraf Mokhtar, Professor', 'role': 'CONTACT', 'phone': '+201001443006'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diana Mostafa Habeb', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Fixed Prosthodontics', 'investigatorFullName': 'Diana Mostafa Habeb', 'investigatorAffiliation': 'Cairo University'}}}}