Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-04-16 @ 2:23 AM
Study NCT ID:
NCT03286959
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2017-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Liners on Pulpal Outcome and Restoration Survival After Partial Caries Excavation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D002126', 'term': 'Calcium Hydroxide'}, {'id': 'C025702', 'term': 'Dycal'}], 'ancestors': [{'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-26', 'studyFirstSubmitDate': '2017-09-08', 'studyFirstSubmitQcDate': '2017-09-15', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate and compare the clinical and radiographic success with different liners after partial caries excavation', 'timeFrame': 'The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.', 'description': 'CRITERIA FOR SUCCESSFUL OUTCOME The Presence of positive response to vitality tests, absence of tenderness or spontaneous pain will be considered as clinical signs of success while absence of any radiolucency in periapical or furcation region or root resorptions as radiographic signs of successful outcome.\n\nCRITERIA FOR FAILURE The presence of negative vitality tests, spontaneous pain, fistula, swelling, mobility will be considered as clinical signs of failure while presence of any radiolucency in furcation or periapical region, internal or external root resorption as radiographic signs of failure.\n\nAlthough the procedure of partial caries excavation will be considered fully successful only when it shows successful outcome both from maintaining pulpal vitality as per primary outcome measures and intact restoration as per secondary outcome measures described below.'}], 'secondaryOutcomes': [{'measure': 'Evaluate and compare the effect of different liners on survival of composite restorations after partial caries excavation.', 'timeFrame': 'The patients were recalled periodically at 1 month, 3months, 6 months and 12 months after the procedure.', 'description': 'Treatment outcome will be judged on the basis of clinical findings and photographs recorded at the the baseline and at follow up visits on the basis of FDI criteria as described by Hickel et al.\n\nPrimary measurement variable will be restoration Retention/Fractures. But the secondary measurable variables will also be evaluated namely Marginal adaptation, Marginal staining, Postoperative sensitivity and Recurrence of caries. Scoring will range from 1( very good), 2(good, after correction very good), 3(sufficient/satisfactory, minor shortcomings), 4 (unsatisfactory, but repairable) to 5 ( poor, replacement necessary). Restorations rated 4 or 5 in one of the criteria will be classified as clinically unacceptable, excluded from further assessment and will be repaired or replaced'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reversible Pulpitis']}, 'referencesModule': {'references': [{'pmid': '31096259', 'type': 'DERIVED', 'citation': 'Singh S, Mittal S, Tewari S. Effect of Different Liners on Pulpal Outcome after Partial Caries Removal: A Preliminary 12 Months Randomised Controlled Trial. Caries Res. 2019;53(5):547-554. doi: 10.1159/000499131. Epub 2019 May 16.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study was to determine the effectiveness of cavity liners regarding survival of restoration beneath composite restoration after partial caries removal in permanent teeth with deep caries and to evaluate and compare the pulp vitality outcome both clinically and radiologically with and without liners.\n\nStudy was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry \\& Endodontics. Mature permanent mandibular molars with deep dentinal caries and without any signs of irreversible pulpitis were included in the study. After partial excavation of caries, patients were randomly allocated into three groups- RMGIC, CH and DIRECT COMPOSITE group and were restored according to standard protocol.', 'detailedDescription': 'AIM AND OBJECTIVES The present study aims to\n\n1. Evaluate the success of partial caries excavation in mandibular molar teeth.\n2. Evaluate and compare the clinical and radiographic success with RMGIC, calcium hydroxide and without liners after partial caries excavation.\n3. Evaluate and compare the effect of liners on restoration survival after partial caries excavation.\n\nMATERIALS AND METHODS Study subjects were recruited from OPD of Department of conservative dentistry and endodontics, PGIDS, Rohtak.\n\nMETHODOLOGY Prior to treatment, a thorough clinical and radiological examination was carried out and a thorough history was taken.\n\nClinical procedure:\n\nMature mandibular permanent molars exhibiting deep caries involving more than half or two thirds of dentin were chosen for the study.\n\nThe teeth were evaluated by periapical radiographs, periodontal probing, percussion test, and vitality assessment with thermal test and electric pulp test; teeth determined to have reversible pulpitis were included and with irreversible pulpitis were excluded.\n\nAll periapical radiographs were exposed by using constant kVP, mA, and exposure time (70 KVP, 8 mA, and 0.8 sec.) with a Rinn paralleling device.\n\nAfter administration of local anesthesia, rubber dam isolation of the involved tooth was done and tooth was swabbed with betadiene. Carious tissue from lateral walls and dentino enamel junction was removed completely while a layer of soft carious dentin was left adjacent to pulpal or axial wall followed by cleaning with distilled water and drying with sterile filter paper. Then the teeth were randomised into three groups using a computer generated sheet.\n\nGROUP I CH GROUP- The pulpal or axial wall was lined by a layer of dycal as per manufacturer directions and restored with composite restoration using incremental technique.\n\nGROUP II RMGIC GROUP - A layer of resin modified GIC was placed adjacent to pulpal or axial wall and tooth restored as above.\n\nGROUP III DIRECT COMPOSITE GROUP- Tooth was restored with composite restorations as above without placing any liner.\n\nFOLLOW UP- The patients were recalled periodically at 1 month, 3 months, 6 months and 12 months after the procedure for clinical (post operative sensitivity, pain, tenderness, vitality) and radiographic (widening of periodontal ligament space and periapical radiolucency) evaluation. Also, the restoration survival was assessed using modified Hickel criteria where marginal staining, marginal adaptation, fractures and retention, secondary caries and post operative sensitivity were evaluated.\n\nCRITERIA FOR SUCCESSFUL PULPAL OUTCOME A positive vitality test. No pain on percussion. No widening of periodontal ligament on periapical radiograph. No clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis.\n\nCRITERIA FOR FAILURE No response to pulp vitality test. Teeth exhibiting clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '54 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient willing to participate in the study.\n* Mature permanent mandibular molars with deep dentinal caries involving more than half or two thirds of dentin.\n\nExclusion Criteria:\n\n* Primary teeth.\n* Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract, and furcation or apical radiolucency.\n* Immuno-compromised, diabetic, pregnant and hypertensive patients.\n* Positive history of antibiotic and analgesic use.'}, 'identificationModule': {'nctId': 'NCT03286959', 'briefTitle': 'Effect of Liners on Pulpal Outcome and Restoration Survival After Partial Caries Excavation', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'Effect of Different Liners on Pulpal Outcome and Survival of Composite Restorations After Partial Caries Removal: A Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'Shreyasingh'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PCR WITH CALCIUM HYDROXIDE', 'description': 'PCR WITH CALCIUM HYDROXIDE : A layer of dycal (dentsply) was placed adjacent to pulpal or axial wall after mixing as per manufacturer recommendations followed by etching and restoration with composite using incremental technique.', 'interventionNames': ['Procedure: PCR with calcium hydroxide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCR WITH RMGIC', 'description': 'PCR WITH RMGIC: A layer of resin modified liner ( GC Fuji II ) was placed adjacent to pulpal or axial wall and light cured for 40 sec. afterwards the cavity was restored with composite as in other groups.', 'interventionNames': ['Procedure: PCR with RMGIC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCR WITH DIRECT COMPOSITE', 'description': 'PCR WITH DIRECT COMPOSITE: After partial caries excavation , etching and bonding was done directly without using any liner and cavity was restored with composite as in other groups', 'interventionNames': ['Procedure: PCR with direct composite']}], 'interventions': [{'name': 'PCR with calcium hydroxide', 'type': 'PROCEDURE', 'otherNames': ['indirect pulp capping with dycal'], 'armGroupLabels': ['PCR WITH CALCIUM HYDROXIDE']}, {'name': 'PCR with RMGIC', 'type': 'PROCEDURE', 'otherNames': ['indirect pulp capping with RMGIC'], 'armGroupLabels': ['PCR WITH RMGIC']}, {'name': 'PCR with direct composite', 'type': 'PROCEDURE', 'otherNames': ['indirect pulp capping with adhesive restorations'], 'armGroupLabels': ['PCR WITH DIRECT COMPOSITE']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal', 'investigatorFullName': 'Sanjay Tewari', 'investigatorAffiliation': 'Postgraduate Institute of Dental Sciences Rohtak'}}}}