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

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ClinicalTrials.gov Identifier: NCT02678104
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Nedal Abu-Mostafa, Riyadh Colleges of Dentistry and Pharmacy

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.


Condition or disease Intervention/treatment Phase
Dry Socket Procedure: Tooth extraction Drug: Chlorhexidine mouth wash Drug: Intra-alveolar application of Manuka Honey Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Influence of Intra-alveolar Application of Honey on Healing Following Molar Teeth Extraction: A Randomized Clinical Trial
Study Start Date : October 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017


Arm Intervention/treatment
Experimental: Chlorhexidine mouth wash
Tooth extraction. The patients will start using Chlorhexidine mouthwash on 2nd day of extraction twice daily for 7 days.
Procedure: Tooth extraction
Tooth removal

Drug: Chlorhexidine mouth wash
Chlorhexidine mouth wash
Other Name: Oraxine 0.2% Chlorhexidine mouth wash

Experimental: Manuka Honey
intra-alveolar application of Manuka Honey after tooth extraction.
Procedure: Tooth extraction
Tooth removal

Drug: Intra-alveolar application of Manuka Honey
Intra-alveolar application of Manuka Honey directly after extraction.
Other Name: Marks & Spencer Manuka Honey




Primary Outcome Measures :
  1. Pain day 3 [ Time Frame: on the 3rd day ]
    Assessment of pain by (VAS) from (0, 1, 2,….10).


Secondary Outcome Measures :
  1. Empty socket day 3 [ Time Frame: on the 3rd day ]
    By inspection. The socket is empty and does not contain blood clot

  2. Empty socket day 7 [ Time Frame: in the 7th day ]
    By inspection. The socket is empty and does not contain blood clot

  3. Tenderness within the socket day 3 [ Time Frame: on the 3rd day ]
    By probing the socket

  4. Tenderness within the socket day 7 [ Time Frame: on the 7th day ]
    By probing the socket

  5. Pain day 7 [ Time Frame: on the 7th day ]
    Assessment of pain by (VAS) from (0, 1, 2,….10).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678104


Contacts
Contact: Hezekiah A Mosadomi, Professor 00966509995087 prof.mosadomi@riyadh.edu.sa

Locations
Saudi Arabia
RiyadH Colleges of dentistry and Pharmacy Recruiting
Riyadh, Saudi Arabia, 11681
Contact: Hezekiah A. Mosadomi, Professor       prof.mosadomi@riyadh.edu.sa   
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
Investigators
Principal Investigator: Nedal A Abu Mostafa, Lecturer Riyadh Colleges of Dentistry and Pharmacy

Publications of Results:
Other Publications:

Responsible Party: Nedal Abu-Mostafa, Dr., Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT02678104     History of Changes
Other Study ID Numbers: FRP/2016/23
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nedal Abu-Mostafa, Riyadh Colleges of Dentistry and Pharmacy:
Dry Socket
Honey
Tooth Extraction

Additional relevant MeSH terms:
Dry Socket
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents