Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 8:59 AM
Study NCT ID:
NCT04452734
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2020-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2016-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '1 day', 'description': 'Visual Analogue Scale (VAS) used to quantify pain'}, {'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '3rd post op day', 'description': 'Visual Analogue Scale (VAS) used to quantify pain'}, {'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '7th post op day', 'description': 'Visual Analogue Scale (VAS) used to quantify pain'}, {'measure': 'Trismus', 'timeFrame': '1 day', 'description': 'Trismus was quantified/measured using Vernier Calliper.'}, {'measure': 'Trismus', 'timeFrame': '3rd post op day', 'description': 'Trismus was quantified/measured using Vernier Calliper.'}, {'measure': 'Trismus', 'timeFrame': '7th post op day', 'description': 'Trismus was quantified/measured using Vernier Calliper.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tooth Extraction']}, 'referencesModule': {'references': [{'pmid': '21550158', 'type': 'BACKGROUND', 'citation': 'Ogundipe OK, Ugboko VI, Owotade FJ. Can autologous platelet-rich plasma gel enhance healing after surgical extraction of mandibular third molars? J Oral Maxillofac Surg. 2011 Sep;69(9):2305-10. doi: 10.1016/j.joms.2011.02.014. Epub 2011 May 7.'}, {'pmid': '21778014', 'type': 'BACKGROUND', 'citation': 'Celio-Mariano R, de Melo WM, Carneiro-Avelino C. Comparative radiographic evaluation of alveolar bone healing associated with autologous platelet-rich plasma after impacted mandibular third molar surgery. J Oral Maxillofac Surg. 2012 Jan;70(1):19-24. doi: 10.1016/j.joms.2011.03.028. Epub 2011 Jul 20.'}]}, 'descriptionModule': {'briefSummary': "Wisdom tooth extraction is the most common surgical procedure being carried out in oral surgical departments. The complications carried by post operative period include pain and trismus and may affect patient's quality of life.\n\nPRP is an autologous concentrate of platelet in plasma and accelerate healing by production of growth factors. PRP is prepared from patient's own blood and later packed with gel sponge (Spongistone) in the experimental group immediately after surgical extraction of mandibular third molar teeth, followed by suture placement to close the surgical site.", 'detailedDescription': "Wisdom tooth extraction is the most common surgical procedure being carried out in oral surgical departments. The complications carried by post operative period includes pain, swelling, trismus , along with disturbance in post extraction wound healing which may significantly affect patient's quality of life.\n\nPRP is an autologous concentrate of platelet suspended in plasma and accelerate healing by production of various growth factors. PRP is prepared from patient's own blood and later packed with gel sponge (Spongistone) in the experimental group immediately after surgical extraction of mandibular third molar teeth, followed by suture placement to close the surgical site. PRP speeds up healing by concentration of growth factors which can lessen the inflammation and decreases trismus and pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18-45 iyears\n2. Either gender\n3. Patients requiring extraction of mandibular 3rd molars\n4. ASA grade1\n5. Nonsmokers \\& non alcoholics\n6. Not allergic to any medicines\n7. No pain before the extraction procedure\n8. No trismus, i.e. normal mouth opening before the extraction procedure -\n\nExclusion Criteria:\n\na) Systemic diseases b) Compromised immune system c) Platelet count less than 1.5 lacs/cmm d) Allergy to drugs e) Patients not willing to participate in the study f) Pregnant females/Lactating mothers g) Presence of pericoronitis, periapical infection or any associated lesion.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04452734', 'briefTitle': 'Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.', 'orgStudyIdInfo': {'id': 'FUI/CTR/2020/3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Procedure: Surgical Extraction']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group', 'interventionNames': ['Procedure: Platelet Rich Plasma (PRP)', 'Procedure: Surgical Extraction']}], 'interventions': [{'name': 'Platelet Rich Plasma (PRP)', 'type': 'PROCEDURE', 'description': 'PRP was prepared by withdrawing 8-10 ml of patients own blood (IV from antecubiodal area and collected in a vacuum tube coated with anticoagulant (Na citrate). For activation 1 ml of calcium chloride was added to Platelet Rich Plasma. This layer of approximately 2 ml of PRP was then taken into the residual bone cavity along with gel sponge to stimulate regeneration in wound healing after surgical extraction of mandibular third molar tooth followed by sutures', 'armGroupLabels': ['Study Group']}, {'name': 'Surgical Extraction', 'type': 'PROCEDURE', 'description': 'Surgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement.', 'armGroupLabels': ['Control Group', 'Study Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Maidah Hanif, BDS, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foundation University College of Dentistry'}, {'name': 'Muhammad Azhar Sheikh, BDS, MSc, FFD', 'role': 'STUDY_CHAIR', 'affiliation': 'Foundation University College of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}