Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-27 @ 1:28 PM
Study NCT ID:
NCT05161403
Status:
UNKNOWN
Last Update Posted:
2021-12-17
First Post:
2021-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Hyaluronic Acid and Honey in Healing of Multiple Extraction Sockets of Primary Teeth Compared to Saline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}, {'id': 'D006722', 'term': 'Honey'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Neither the operator nor the patients could be blinded due to the nature of the study, but the statistician will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Clinical Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-09-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-03', 'studyFirstSubmitDate': '2021-10-26', 'studyFirstSubmitQcDate': '2021-12-03', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound healing size in length and width', 'timeFrame': 'After one week will be calculated the size (lentgh and width) of socket', 'description': 'There is only one outcome (wound healing)\n\n• Multiple measurements (Digital caliper, color, palpation, presence of pus, gingival margin status).\n\n1. Digital caliper: a device used to calculate the size of the socket (width and length) buccolingual in mesiodistal with measurement of mm.\n2. Color: normal (pinkish gingiva) Up normal (reddish gingiva)\n3. Palpation: if there is bleeding or not.\n4. Presence of pus: yes or no\n5. Gingival margin: epithelization (yes or no)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wound Heal']}, 'referencesModule': {'references': [{'pmid': '33086538', 'type': 'RESULT', 'citation': 'Naaman R, El-Housseiny AA, Alamoudi N, Helal N, Sahhaf R. Reliability and Validity of the Arabic Version of a Questionnaire Assessing Pain, Discomfort and Related Jaw Function Impairment after Extraction of Primary Teeth in Children. Dent J (Basel). 2020 Oct 19;8(4):120. doi: 10.3390/dj8040120.'}, {'pmid': '31954318', 'type': 'RESULT', 'citation': 'Iacopetti I, Perazzi A, Martinello T, Gemignani F, Patruno M. Hyaluronic acid, Manuka honey and Acemannan gel: Wound-specific applications for skin lesions. Res Vet Sci. 2020 Apr;129:82-89. doi: 10.1016/j.rvsc.2020.01.009. Epub 2020 Jan 11.'}, {'pmid': '32771444', 'type': 'RESULT', 'citation': 'Maria de Souza G, Elias GM, Pereira de Andrade PF, Andrade Sales KN, Galvao EL, Moreira Falci SG. The Effectiveness of Hyaluronic Acid in Controlling Pain, Edema, and Trismus After Extraction of Third Molars: Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2020 Dec;78(12):2154.e1-2154.e12. doi: 10.1016/j.joms.2020.07.005. Epub 2020 Jul 14.'}, {'pmid': '31607720', 'type': 'RESULT', 'citation': 'Mokhtari S, Sanati I, Abdolahy S, Hosseini Z. Evaluation of the effect of honey on the healing of tooth extraction wounds in 4- to 9-year-old children. Niger J Clin Pract. 2019 Oct;22(10):1328-1334. doi: 10.4103/njcp.njcp_102_19.'}, {'pmid': '7103456', 'type': 'RESULT', 'citation': 'Jaffe HW, Sweeney HM, Weinstein RA, Kabins SA, Nathan C, Cohen S. Structural and phenotypic varieties of gentamicin resistance plasmids in hospital strains of Staphylococcus aureus and coagulase-negative staphylococci. Antimicrob Agents Chemother. 1982 May;21(5):773-9. doi: 10.1128/AAC.21.5.773.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of hyaluronic acid and honey compared to saline in healing of multiple extraction sockets of primary teeth in a group of children aging from Two to Seven years old.', 'detailedDescription': 'A dental extraction is one of the most unpleasant experiences in children, especially for those who have undergone traumatic experiences, and this is likely to reduce future visits to the dental clinic if the treatment is not managed properly.\n\nAlveolar osteitis is one of the most common complications following dental extraction. It is considered one of the most studied complications in dentistry, and many risk factors contribute to its occurrence including being a female, young age, tobacco use, difficult or traumatic extractions, pre-existing infection, and use of vasoconstrictor in local anesthesia. Alveolar osteitis occurs during the first three days following the day of extraction, so that the socket is devoid of the blood clot, resulting in the exposure of the bare alveolar bone.\n\nMany medicines were and are still used in treating wounds, but they are somewhat expensive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age: from Two to Seven years old age.\n\n * Both genders.\n * Children with badly decayed multiple primary teeth beyond repair.\n * Treated under general anesthesia.\n\nExclusion Criteria:\n\n* • History of systemic disease.\n\n * Allergy to honey.\n * Repeatedly used honey during the previous 6 month period.'}, 'identificationModule': {'nctId': 'NCT05161403', 'briefTitle': 'The Efficacy of Hyaluronic Acid and Honey in Healing of Multiple Extraction Sockets of Primary Teeth Compared to Saline', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Efficacy of Hyaluronic Acid and Honey in Healing of Multiple Extraction Sockets of Primary Teeth Compared to Saline in a Group of Egyptian Children', 'orgStudyIdInfo': {'id': 'wound healing on pediatric'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hyaluronic acid.', 'description': '1mm layer of hyaluronic acid on a piece of gauze will be applied directly to the sockets wound for 45 minutes at baseline and on the third \\& seventh day after extraction of teeth.', 'interventionNames': ['Drug: Hyaluronic acid', 'Dietary Supplement: honey']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Honey', 'description': '1mm layer of Honey on a piece of gauze will be applied directly to the sockets wound for 45 minutes at baseline and on the third \\& seventh day after extraction of teeth.', 'interventionNames': ['Drug: Hyaluronic acid', 'Dietary Supplement: honey']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'a piece of gauze moistened with normal saline will be applied directly to the sockets wound for 45 minutes at baseline and on the third \\& seventh day after extraction of teeth.', 'interventionNames': ['Drug: Hyaluronic acid', 'Dietary Supplement: honey']}], 'interventions': [{'name': 'Hyaluronic acid', 'type': 'DRUG', 'description': 'Wound healing is still a clinical challenge especially in patients who undergo several tooth extractions under general anesthesia or those undergoing major surgeries or those with systemic conditions that disrupt the wound healing process.\n\nuse of this natural substance is a simple and cost-effective technique and is easily tolerated by children.', 'armGroupLabels': ['Honey', 'Hyaluronic acid.', 'Saline']}, {'name': 'honey', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Wound healing is still a clinical challenge especially in patients who undergo several tooth extractions under general anesthesia or those undergoing major surgeries or those with systemic conditions that disrupt the wound healing process.\n\nUse of this natural substance is a simple and cost-effective technique and is easily tolerated by children.', 'armGroupLabels': ['Honey', 'Hyaluronic acid.', 'Saline']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': "Anas M.gassan Raima, master's", 'role': 'CONTACT', 'email': 'anasrahima@dentistry.cu.edu.eg', 'phone': '01017562309'}, {'name': 'Sherine Badr Youness, Associate Prof', 'role': 'CONTACT', 'phone': '01001408341'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anas Rahima', 'investigatorAffiliation': 'Cairo University'}}}}