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