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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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 p
Sponsor: Riyadh Colleges of Dentistry and Pharmacy

Current Primary Outcome: Pain day 3 [ Time Frame: on the 3rd day ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Riyadh Colleges of Dentistry and Pharmacy

Dates:
Date Received: January 24, 2016
Date Started: October 2016
Date Completion: August 2017
Last Updated: March 13, 2017
Last Verified: March 2017