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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Influence of Intra-alveolar Application of Honey on Healing Following Molar Teeth Extraction: A Randomized Clinical Trial

Conditions
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Dry Socket

Intervention / Treatment
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* Procedure: Tooth extraction
* Drug: Chlorhexidine mouth wash
* Drug: Intra-alveolar application of Manuka Honey


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine mouth wash<br>Tooth extraction. The patients will start using Chlorhexidine mouthwash on 2nd day of extraction twice daily for 7 days. | Procedure: Tooth extraction<br>* Tooth removal<br>Drug: Chlorhexidine mouth wash<br>* Chlorhexidine mouth wash<br>* Other names: Oraxine 0.2% Chlorhexidine mouth wash;|
| Experimental: Manuka Honey<br>intra-alveolar application of Manuka Honey after tooth extraction. | Procedure: Tooth extraction<br>* Tooth removal<br>Drug: Intra-alveolar application of Manuka Honey<br>* Intra-alveolar application of Manuka Honey directly after extraction.<br>* Other names: Marks & Spencer Manuka Honey;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain day 3 | Assessment of pain by (VAS) from (0, 1, 2,….10). | on the 3rd day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empty socket day 3 | By inspection. The socket is empty and does not contain blood clot | on the 3rd day | 
| Empty socket day 7 | By inspection. The socket is empty and does not contain blood clot | in the 7th day | 
| Tenderness within the socket day 3 | By probing the socket | on the 3rd day | 
| Tenderness within the socket day 7 | By probing the socket | on the 7th day | 
| Pain day 7 | Assessment of pain by (VAS) from (0, 1, 2,….10). | on the 7th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Socket, Honey, Tooth Extraction