Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT06768567
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2025-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Hemostasis Time on Partial Pulpotomy in Teeth With Clinical Signs Indicative of Irreversible Pulpitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-27', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1.Clinical success rate', 'timeFrame': 'baseline to 12 months', 'description': 'Clinical criteria of success:-\n\n1. No pain or discomfort except for the first few days after treatment.\n2. No tenderness to palpation or percussion and the tooth is functional.\n3. Normal mobility and probing pocket depth.\n4. Healthy soft tissues around teeth with no swelling, sinus tract.'}, {'measure': '2.Radiographic success rate', 'timeFrame': 'baseline to 12 months', 'description': 'Radiographic success criteria:-\n\n1. No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph.\n2. Complete radiographic healing'}], 'secondaryOutcomes': [{'measure': 'Post Operative Pain', 'timeFrame': 'Baseline to 7 days]', 'description': 'To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain'}, {'measure': 'OHRQoL assessment', 'timeFrame': 'baseline and at 24 hours, day 2, day 3, day4, day 5, day 6 and day 7 after the treatment.', 'description': 'OHIP-14 questionnare will be used to assess the quality of life.It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. It will be scored using a Lickert scale:\n\nnever=0; hardly ever=1; occasionally=2; fairly often=3; very often=4. Total score will be calculated ranging from 0-56, with higher score denoting the worst OHRQoL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['partial pulpotomy', 'hemostatsis time'], 'conditions': ['Irreversible Pulpitis', 'Partial Pulpotomy']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective study is to investigate the influence of time taken to achieve hemostasis on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.\n\nOBJECTIVE:-\n\n1. To evaluate clinical and radiographic success of time taken to achieve hemostasis on outcome of partial pulpotomy in mature permanent teeth with clinical signs indicative of irreversible pulpitis.\n2. To evaluate OHRQoL and pain incidence \\& severity after partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.\n\nParticipants will of age group 18 to 45 years will be included and divided into two groups based on hemostasis time:\n\nI(Intervention) - 6minutes C (Comparison) - 7-12 minutes', 'detailedDescription': 'TITLE:- Evaluation of hemostasis time on partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.\n\nP (Population) - Mature permanent molars with clinical signs of irreversible pulpitis.\n\nI (Intervention) - 6minutes C (Comparison) - 7-12 minutes O (Outcome) - Assessment of clinical and radiographic success at 12 months of follow up .\n\nAssessment of OHRQoL at baseline, post-operatively every 24 hours for 1 week \\& incidence and severity of pain at baseline and post-operatively every 24 hours till 1 week.\n\nTime taken to achieve hemostasis has been suggested as a reliable surrogate measure to determine the depth of inflammation in the pulp. In absence of any other intraoperative indicator, it serves as a useful guide to the extent of pulp tissue removal required during pulpotomy. This trial will help formulate evidence based guideline regarding time for hemostasis advisable to achieve optimum success during pulpotomy in teeth with signs indicative of irreversible pulpitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mature permanent mandibular molars with carious pulp exposures and signs suggestive of irreversible pulpitis.\n* vital pulp with demonstrable bleeding upon entry.\n* The tooth is restorable.\n* Tooth with mobility and probing depth within normal limits.\n* Soft tissues around the tooth are normal with no swelling or sinus tract.\n* No evidence of chronic apical periodontitis (PAI 1,2)\n\nExclusion Criteria:\n\n* patients who report history of antibiotic intake in past 1 month or analgesic intake in past 3 days.\n* pregnant women.\n* absence of opposing teeth\n* 3rd molars\n* medically compromised patients .\n* Tenderness on percussion positive\n* pathologic mobility'}, 'identificationModule': {'nctId': 'NCT06768567', 'briefTitle': 'Evaluation of Hemostasis Time on Partial Pulpotomy in Teeth With Clinical Signs Indicative of Irreversible Pulpitis', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'Evaluation of Effect of Hemostasis Time on Partial Pulpotomy in Mature Permanent Teeth With Clinical Signs Indicative of Irreversible Pulpitis', 'orgStudyIdInfo': {'id': 'Vinita yadav'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hemostasis time upto 6 minutes', 'description': 'after partial pulpotomy, procedure pulp wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 minutes and will be repeated if required and time taken to achieve hemostasis will be recorded using stop watch.', 'interventionNames': ['Procedure: effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.']}, {'type': 'EXPERIMENTAL', 'label': 'hemostasis time 7 to 12 minutes', 'description': 'after partial pulpotomy, procedure pulp wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 minutes and will be repeated if required and time taken to achieve hemostasis will be recorded using stop watch.Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 12 minutes.', 'interventionNames': ['Procedure: effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.']}], 'interventions': [{'name': 'effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.', 'type': 'PROCEDURE', 'description': 'After caries removal and pulp exposure pulp tissue is amputated and pulpal wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 to 3 minutes and will be repeated if required and time taken to achieve hemostasis will be recorded using stop watch. Teeth in which bleeding will be controlled within 6 mins will be placed in Group A, while those in which it gets controlled between 7 to 12 mins will be included in Group B. Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 12 minutes. Followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin.', 'armGroupLabels': ['Hemostasis time upto 6 minutes', 'hemostasis time 7 to 12 minutes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'country': 'India', 'facility': 'PGIDS', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}], 'overallOfficials': [{'name': 'Dr. Pankaj Sangwan, MDS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'PGIDS, Rohtak, Haryana 124001'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}