The Influence of Intra-alveolar Application of Honey on Healing Following Extraction
NCT ID: NCT02678104
Last Updated: 2017-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2016-10-31
2017-08-31
Brief Summary
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Re-evaluation:
Postoperative 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.
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Detailed Description
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The 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.
Teeth 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.
The 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.
Both 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.
Follow up:
The 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.
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.
Frequencies and percentages are calculated for qualitative data (SPSS software version.22). Chi-square test will be applied to compare both subgroups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Chlorhexidine mouth wash
Tooth extraction. The patients will start using Chlorhexidine mouthwash on 2nd day of extraction twice daily for 7 days.
Tooth extraction
Tooth removal
Chlorhexidine mouth wash
Chlorhexidine mouth wash
Manuka Honey
intra-alveolar application of Manuka Honey after tooth extraction.
Tooth extraction
Tooth removal
Intra-alveolar application of Manuka Honey
Intra-alveolar application of Manuka Honey directly after extraction.
Interventions
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Tooth extraction
Tooth removal
Chlorhexidine mouth wash
Chlorhexidine mouth wash
Intra-alveolar application of Manuka Honey
Intra-alveolar application of Manuka Honey directly after extraction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant women
* Breastfeeding women
* Women are using oral contraceptives
* Allergy to chlorhexidine
* Allergy to honey
* Presence of acute infection, cystic lesions
* Traumatic extraction
* Extraction requiring bone reduction
* Extractions lasted more than 30 minutes
18 Years
60 Years
ALL
Yes
Sponsors
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Riyadh Colleges of Dentistry and Pharmacy
OTHER
Responsible Party
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Nedal Abu-Mostafa
Dr.
Principal Investigators
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Nedal A Abu Mostafa, Lecturer
Role: PRINCIPAL_INVESTIGATOR
Riyadh Colleges of Dentistry and Pharmacy
Locations
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RiyadH Colleges of dentistry and Pharmacy
Riyadh, Riyadh Region, Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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FRP/2016/23
Identifier Type: -
Identifier Source: org_study_id
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