Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT04495205
Status:
UNKNOWN
Last Update Posted:
2020-07-31
First Post:
2020-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Non-eugenol Periodontal Pack With and Without PRF on Post-operative Pain and Wound Healing After Gingival Depigmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient and the statistician are masked'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain', 'timeFrame': '1st day post-operative', 'description': 'Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)'}, {'measure': 'Post-operative pain', 'timeFrame': '3rd day post-operative', 'description': 'Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)'}, {'measure': 'Post-operative pain', 'timeFrame': '5th day post-operative', 'description': 'Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)'}], 'secondaryOutcomes': [{'measure': 'Re-epithelization', 'timeFrame': '5th day post-operative', 'description': 'Toulodine Blue test: dark blue = positive (worst score), light blue = negative (better score)'}, {'measure': 'Wound healing', 'timeFrame': '3rd day post-operative', 'description': 'Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)'}, {'measure': 'Wound healing', 'timeFrame': '5th day post-operative', 'description': 'Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)'}, {'measure': 'Re-pigmentation', 'timeFrame': '6 months post-operative', 'description': 'Re-pigmentation of de pigmented site (Kumar, Bhat and Bhat, 2012): minimum score 0 (absence of depigmentation, maximum score 3 (Diffuse brown to black pigmentation, marginal, and attached)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Pigmentation']}, 'referencesModule': {'references': [{'pmid': '31367132', 'type': 'BACKGROUND', 'citation': 'Dahiya R, Blaggana A, Panwar V, Kumar S, Kathuria A, Malik S. Clinical and histological comparison of platelet-rich fibrin versus non-eugenol periodontal dressing in the treatment of gingival hyperpigmentation. J Indian Soc Periodontol. 2019 Jul-Aug;23(4):345-350. doi: 10.4103/jisp.jisp_688_18.'}]}, 'descriptionModule': {'briefSummary': 'In an era where less than ideal esthetics is not accepted, the request for esthetic procedures is widely sought after. Melanin, a brown pigment, is the most common natural pigment contributing to endogenous pigmentation of gingiva. It is a non-hemoglobin-derived pigment formed by cells called melaonocytes\n\nDental cosmetic procedures including gingival depigmentation among the young generation are vastly becoming popular due to the public advertising of what the "ideal smile" should be. This means that brown/ pigmented gingiva is not esthetically accepted by modern standards. Numerous techniques for depigmentation were developed including surgical abrasion, lasers, chemicals and thermal techniques.\n\nThe use of post-operative non-eugenol containing periodontal packs acts as a mechanical barrier for coverage of the denuded area which prevents bleeding and promotes healing by preventing trauma to the area.\n\nPlatelet Rich Fibrin (PRF) is a form of concentrated suspension of growth factors that promote healing and tissue regeneration. Its use in the medical and dental fields is expanding during the recent year.', 'detailedDescription': 'Gingival depigmentation procedures especially bur abrasion and scalpel surgical techniques require the use of post-operative periodontal pack. The periodontal pack protects the surgical site from surface trauma, stops the post-operative bleeding and infection as well as stabilizing the blood clot and accelerate healing.\n\nHowever, a review article discussed the adverse effects of periodontal pack as it may cause plaque induced inflammation, patient discomfort due to difficulty in eating and irritation of the tissues. In the article, there were clinical trials that advocated that wound healing could occur without the need of periodontal pack if the surgical wound was kept clean alone indicating that the pack does not affect the wound healing.\n\nThis gave rise to idea to use a material that has been proven to accelerate wound healing and decrease the patient discomfort to be placed under the periodontal pack which would be used only as a protective barrier.\n\nSeveral studies tested platelet rich concentrates as adjunctive methods under periodontal packs verses periodontal packs alone after surgical abrasion of gingival depigmentation. They found that there was a clinical, histological and statistical difference between the groups favoring the platelet concentrate groups.\n\nUsing PRF which is a second generation platelet concentrate first developed by Choukroun et al in 2001 used as a membrane could provide accelerated wound healing properties which would accelerate ginigival re-epithelization . Using a periodontal pack is conventionally used which will provide a mechanical barrier to protect the wound from any stimulus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages18-40 years old\n* Systemically healthy\n* Mild to moderate gingival pigmentations\n* Gingival and plaque index \\<1\n* Good oral hygiene\n* Thick gingival biotypes\n* Keratinized gingiva \\>2mm\n\nExclusion Criteria:\n\n* Smokers\n* Taking any medications that could affect healing\n* Pervious depigmentation procedures\n* Pregnant or lactating females\n* Pervious periodontal surgery within the last 6 months before the start of the trial\n* Endodontically treated teeth'}, 'identificationModule': {'nctId': 'NCT04495205', 'briefTitle': 'Effect of Non-eugenol Periodontal Pack With and Without PRF on Post-operative Pain and Wound Healing After Gingival Depigmentation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Comparison of the Effect of Non-eugenol Containing Periodontal Pack With and Without Platelet Rich Fibrin on Post-operative Pain and Wound Healing After Surgical Gingival Depigmentation: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AHReda'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-eugenol containing periodontal packs with PRF', 'description': 'Non-eugenol containing periodontal packs with PRF after gingival de-pigmentation', 'interventionNames': ['Biological: PRF under non-eugenol containing periodontal pack']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-eugenol containing periodontal packs', 'description': 'Non-eugenol containing periodontal packs after gingival de-pigmentation', 'interventionNames': ['Other: Non-eugenol containing periodontal pack']}], 'interventions': [{'name': 'PRF under non-eugenol containing periodontal pack', 'type': 'BIOLOGICAL', 'otherNames': ['Platelet Rich Fibrin'], 'description': 'Platelet Rich Fibrin under non-eugenol containing periodontal pack', 'armGroupLabels': ['Non-eugenol containing periodontal packs with PRF']}, {'name': 'Non-eugenol containing periodontal pack', 'type': 'OTHER', 'description': 'Non-eugenol containing periodontal pack after gingival depigmentation', 'armGroupLabels': ['Non-eugenol containing periodontal packs']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mona S Darhous, Professor', 'role': 'CONTACT', 'email': 'mona.darhous@yahoo.com', 'phone': '00201223155955'}], 'facility': 'Cairo University Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Masters Student', 'investigatorFullName': 'Aya Hesham Reda', 'investigatorAffiliation': 'Cairo University'}}}}