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The Influence of Intra-alveolar Application of Honey on Healing Following Extraction

Primary Purpose

Dry Socket

Status
Unknown status
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Tooth extraction
Chlorhexidine mouth wash
Intra-alveolar application of Manuka Honey
Sponsored by
Riyadh Colleges of Dentistry and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dry Socket focused on measuring Dry Socket, Honey, Tooth Extraction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Patients who have extraction of single molar tooth

Exclusion criteria:

  • Patients with uncontrolled systemic diseases
  • 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

Sites / Locations

  • RiyadH Colleges of dentistry and PharmacyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Chlorhexidine mouth wash

Manuka Honey

Arm Description

Tooth extraction. The patients will start using Chlorhexidine mouthwash on 2nd day of extraction twice daily for 7 days.

intra-alveolar application of Manuka Honey after tooth extraction.

Outcomes

Primary Outcome Measures

Pain day 3
Assessment of pain by (VAS) from (0, 1, 2,….10).

Secondary Outcome Measures

Empty socket day 3
By inspection. The socket is empty and does not contain blood clot
Empty socket day 7
By inspection. The socket is empty and does not contain blood clot
Tenderness within the socket day 3
By probing the socket
Tenderness within the socket day 7
By probing the socket
Pain day 7
Assessment of pain by (VAS) from (0, 1, 2,….10).

Full Information

First Posted
January 24, 2016
Last Updated
March 13, 2017
Sponsor
Riyadh Colleges of Dentistry and Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT02678104
Brief Title
The Influence of Intra-alveolar Application of Honey on Healing Following Extraction
Official Title
The Influence of Intra-alveolar Application of Honey on Healing Following Molar Teeth Extraction: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Colleges of Dentistry and Pharmacy

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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. 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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Socket
Keywords
Dry Socket, Honey, Tooth Extraction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine mouth wash
Arm Type
Experimental
Arm Description
Tooth extraction. The patients will start using Chlorhexidine mouthwash on 2nd day of extraction twice daily for 7 days.
Arm Title
Manuka Honey
Arm Type
Experimental
Arm Description
intra-alveolar application of Manuka Honey after tooth extraction.
Intervention Type
Procedure
Intervention Name(s)
Tooth extraction
Intervention Description
Tooth removal
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouth wash
Other Intervention Name(s)
Oraxine 0.2% Chlorhexidine mouth wash
Intervention Description
Chlorhexidine mouth wash
Intervention Type
Drug
Intervention Name(s)
Intra-alveolar application of Manuka Honey
Other Intervention Name(s)
Marks & Spencer Manuka Honey
Intervention Description
Intra-alveolar application of Manuka Honey directly after extraction.
Primary Outcome Measure Information:
Title
Pain day 3
Description
Assessment of pain by (VAS) from (0, 1, 2,….10).
Time Frame
on the 3rd day
Secondary Outcome Measure Information:
Title
Empty socket day 3
Description
By inspection. The socket is empty and does not contain blood clot
Time Frame
on the 3rd day
Title
Empty socket day 7
Description
By inspection. The socket is empty and does not contain blood clot
Time Frame
in the 7th day
Title
Tenderness within the socket day 3
Description
By probing the socket
Time Frame
on the 3rd day
Title
Tenderness within the socket day 7
Description
By probing the socket
Time Frame
on the 7th day
Title
Pain day 7
Description
Assessment of pain by (VAS) from (0, 1, 2,….10).
Time Frame
on the 7th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Patients who have extraction of single molar tooth Exclusion criteria: Patients with uncontrolled systemic diseases 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hezekiah A Mosadomi, Professor
Phone
00966509995087
Email
prof.mosadomi@riyadh.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nedal A Abu Mostafa, Lecturer
Organizational Affiliation
Riyadh Colleges of Dentistry and Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
RiyadH Colleges of dentistry and Pharmacy
City
Riyadh
ZIP/Postal Code
11681
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hezekiah A. Mosadomi, Professor
Email
prof.mosadomi@riyadh.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25475768
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.
Results Reference
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PubMed Identifier
10800910
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.
Results Reference
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PubMed Identifier
10982947
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.
Results Reference
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PubMed Identifier
15660084
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.
Results Reference
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PubMed Identifier
3416123
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.
Results Reference
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PubMed Identifier
25742878
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.
Results Reference
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PubMed Identifier
20576085
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.
Results Reference
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PubMed Identifier
19155824
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.
Results Reference
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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.
Results Reference
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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.
Results Reference
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The Influence of Intra-alveolar Application of Honey on Healing Following Extraction

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