Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-25 @ 3:00 AM
Study NCT ID:
NCT02678104
Status:
UNKNOWN
Last Update Posted:
2017-03-14
First Post:
2016-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Intra-alveolar Application of Honey on Healing Following Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004368', 'term': 'Dry Socket'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014081', 'term': 'Tooth Extraction'}], 'ancestors': [{'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2016-01-24', 'studyFirstSubmitQcDate': '2016-02-04', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain day 3', 'timeFrame': 'on the 3rd day', 'description': 'Assessment of pain by (VAS) from (0, 1, 2,….10).'}], 'secondaryOutcomes': [{'measure': 'Empty socket day 3', 'timeFrame': 'on the 3rd day', 'description': 'By inspection. The socket is empty and does not contain blood clot'}, {'measure': 'Empty socket day 7', 'timeFrame': 'in the 7th day', 'description': 'By inspection. The socket is empty and does not contain blood clot'}, {'measure': 'Tenderness within the socket day 3', 'timeFrame': 'on the 3rd day', 'description': 'By probing the socket'}, {'measure': 'Tenderness within the socket day 7', 'timeFrame': 'on the 7th day', 'description': 'By probing the socket'}, {'measure': 'Pain day 7', 'timeFrame': 'on the 7th day', 'description': 'Assessment of pain by (VAS) from (0, 1, 2,….10).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry Socket', 'Honey', 'Tooth Extraction'], 'conditions': ['Dry Socket']}, 'referencesModule': {'references': [{'pmid': '25475768', 'type': 'BACKGROUND', 'citation': 'Abu-Mostafa NA, Alqahtani A, Abu-Hasna M, Alhokail A, Aladsani A. A randomized clinical trial compared the effect of intra-alveolar 0.2 % Chlorohexidine bio-adhesive gel versus 0.12% Chlorohexidine rinse in reducing alveolar osteitis following molar teeth extractions. Med Oral Patol Oral Cir Bucal. 2015 Jan 1;20(1):e82-7. doi: 10.4317/medoral.19932.'}, {'pmid': '10800910', 'type': 'BACKGROUND', 'citation': 'Alexander RE. Dental extraction wound management: a case against medicating postextraction sockets. J Oral Maxillofac Surg. 2000 May;58(5):538-51. doi: 10.1016/s0278-2391(00)90017-x. No abstract available.'}, {'pmid': '10982947', 'type': 'BACKGROUND', 'citation': 'Bloomer CR. Alveolar osteitis prevention by immediate placement of medicated packing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Sep;90(3):282-4. doi: 10.1067/moe.2000.108919.'}, {'pmid': '15660084', 'type': 'BACKGROUND', 'citation': 'Caso A, Hung LK, Beirne OR. Prevention of alveolar osteitis with chlorhexidine: a meta-analytic review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Feb;99(2):155-9. doi: 10.1016/j.tripleo.2004.05.009.'}, {'pmid': '3416123', 'type': 'BACKGROUND', 'citation': 'Efem SE. Clinical observations on the wound healing properties of honey. Br J Surg. 1988 Jul;75(7):679-81. doi: 10.1002/bjs.1800750718.'}, {'pmid': '25742878', 'type': 'BACKGROUND', 'citation': 'Jull AB, Cullum N, Dumville JC, Westby MJ, Deshpande S, Walker N. Honey as a topical treatment for wounds. Cochrane Database Syst Rev. 2015 Mar 6;2015(3):CD005083. doi: 10.1002/14651858.CD005083.pub4.'}, {'pmid': '20576085', 'type': 'BACKGROUND', 'citation': 'Nasir NA, Halim AS, Singh KK, Dorai AA, Haneef MN. Antibacterial properties of tualang honey and its effect in burn wound management: a comparative study. BMC Complement Altern Med. 2010 Jun 24;10:31. doi: 10.1186/1472-6882-10-31.'}, {'pmid': '19155824', 'type': 'BACKGROUND', 'citation': 'Pieper B. Honey-based dressings and wound care: an option for care in the United States. J Wound Ostomy Continence Nurs. 2009 Jan-Feb;36(1):60-6; quiz 67-8. doi: 10.1097/01.WON.0000345177.58740.7d.'}, {'pmid': '25298714', 'type': 'BACKGROUND', 'citation': 'Singh V, Pal US, Singh R, Soni N. Honey a sweet approach to alveolar osteitis: A study. Natl J Maxillofac Surg. 2014 Jan;5(1):31-4. doi: 10.4103/0975-5950.140166.'}, {'pmid': '25057231', 'type': 'RESULT', 'citation': 'Atwa AD, AbuShahba RY, Mostafa M, Hashem MI. Effect of honey in preventing gingivitis and dental caries in patients undergoing orthodontic treatment. Saudi Dent J. 2014 Jul;26(3):108-14. doi: 10.1016/j.sdentj.2014.03.001. Epub 2014 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'A prospective randomized parallel trial will be carried out on 100 patients who have extraction of single molar tooth. Teeth extractions will be done under local anesthesia. The patients will be divided randomly into two parallel groups. Group 1: The patients will start using Chlorhexidine mouthwash on the second day of extraction twice daily for 7 days. Group 2: After extraction, Manuka Honey will be applied topically into the extraction socket. Postoperative instructions will be given for all patients in addition to the prescription of ibuprofen 600 mg every 8 hours for 3 days.\n\nRe-evaluation:\n\nPostoperative day 3: tenderness with probing the socket, empty socket, food debris, halitosis and assessment of pain. For group 2, the intra-alveolar application of honey will be repeated. Re-evaluation will be repeated in the seventh post-operative day. Acute alveolar osteitis, (dry socket) is diagnosed if the patient presented between the 2nd and 4th days with pain or tenderness in the socket with probing, empty socket and food debris with or without halitosis.', 'detailedDescription': "A prospective randomized experimental parallel trial will be carried out on 100 male and female patients who have extraction of single molar tooth. Extractions will be performed by dental interns or dental students under supervision of surgery instructors in the Colleges' Clinics.\n\nThe study has been registered in the College's Research Center, with a registration number of FRP/2016/23. It will follow the World Medical Association Declaration of Helsinki, the patients will be informed about the objectives of the study, and informed consent has to be signed. All required information was documented in the questionnaire paper regarding name, age, gender, mobile number, file number, smoking, medical condition, tooth indicated for extraction, pre-operative pain and halitosis.\n\nTeeth extractions will be done under local anesthesia. Simple extractions will be done by elevators and forceps, while root separations will be done using a surgical handpiece and burs with normal saline irrigation.\n\nThe patients will be divided randomly into two parallel groups by asking them to choose 1 out of 100 playing cards. These cards, which have images of different shapes, have been mixed. The first shape includes 50 cards and represents the first study group, while the second shape includes 50 cards and represents the second study group.\n\nBoth groups will receive a bottle of 0.2 % Chlorhexidine mouthwash. Group 1: The patients will start using Chlorhexidine mouthwash on the second day of extraction twice daily for 7 days. Group 2: After tooth extraction, Manuka Honey will be applied topically by a cotton swab into the extraction socket.\n\nFollow up:\n\nThe patients will be followed in the third postoperative day. Re-evaluation includes tenderness with probing the socket, empty socket, and assessment of pain by (VAS) from (0, 1, 2,….10). Score 0 representing no pain, 10 representing severe pain. Re-evaluation will be repeated in the seventh post-operative day including the same evaluation points of the third day.\n\nAcute alveolar osteitis, (dry socket) is diagnosed if the patient presented between the 2nd and 4th days with pain or tenderness in the socket with probing, empty socket.\n\nFrequencies and percentages are calculated for qualitative data (SPSS software version.22). Chi-square test will be applied to compare both subgroups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients who have extraction of single molar tooth\n\nExclusion criteria:\n\n* Patients with uncontrolled systemic diseases\n* Pregnant women\n* Breastfeeding women\n* Women are using oral contraceptives\n* Allergy to chlorhexidine\n* Allergy to honey\n* Presence of acute infection, cystic lesions\n* Traumatic extraction\n* Extraction requiring bone reduction\n* Extractions lasted more than 30 minutes'}, 'identificationModule': {'nctId': 'NCT02678104', 'briefTitle': 'The Influence of Intra-alveolar Application of Honey on Healing Following Extraction', 'organization': {'class': 'OTHER', 'fullName': 'Riyadh Colleges of Dentistry and Pharmacy'}, 'officialTitle': 'The Influence of Intra-alveolar Application of Honey on Healing Following Molar Teeth Extraction: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'FRP/2016/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine mouth wash', 'description': 'Tooth extraction. The patients will start using Chlorhexidine mouthwash on 2nd day of extraction twice daily for 7 days.', 'interventionNames': ['Procedure: Tooth extraction', 'Drug: Chlorhexidine mouth wash']}, {'type': 'EXPERIMENTAL', 'label': 'Manuka Honey', 'description': 'intra-alveolar application of Manuka Honey after tooth extraction.', 'interventionNames': ['Procedure: Tooth extraction', 'Drug: Intra-alveolar application of Manuka Honey']}], 'interventions': [{'name': 'Tooth extraction', 'type': 'PROCEDURE', 'description': 'Tooth removal', 'armGroupLabels': ['Chlorhexidine mouth wash', 'Manuka Honey']}, {'name': 'Chlorhexidine mouth wash', 'type': 'DRUG', 'otherNames': ['Oraxine 0.2% Chlorhexidine mouth wash'], 'description': 'Chlorhexidine mouth wash', 'armGroupLabels': ['Chlorhexidine mouth wash']}, {'name': 'Intra-alveolar application of Manuka Honey', 'type': 'DRUG', 'otherNames': ['Marks & Spencer Manuka Honey'], 'description': 'Intra-alveolar application of Manuka Honey directly after extraction.', 'armGroupLabels': ['Manuka Honey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11681', 'city': 'Riyadh', 'state': 'Riyadh Region', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Hezekiah A. Mosadomi, Professor', 'role': 'CONTACT', 'email': 'prof.mosadomi@riyadh.edu.sa'}], 'facility': 'RiyadH Colleges of dentistry and Pharmacy', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Hezekiah A Mosadomi, Professor', 'role': 'CONTACT', 'email': 'prof.mosadomi@riyadh.edu.sa', 'phone': '00966509995087'}], 'overallOfficials': [{'name': 'Nedal A Abu Mostafa, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riyadh Colleges of Dentistry and Pharmacy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riyadh Colleges of Dentistry and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Nedal Abu-Mostafa', 'investigatorAffiliation': 'Riyadh Colleges of Dentistry and Pharmacy'}}}}