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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02678104
Enrollment
100
Registered
2016-02-09
Start date
2016-10-31
Completion date
2017-08-31
Last updated
2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Socket

Keywords

Dry Socket, Honey, Tooth Extraction

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.

Interventions

PROCEDURETooth extraction

Tooth removal

Chlorhexidine mouth wash

DRUGIntra-alveolar application of Manuka Honey

Intra-alveolar application of Manuka Honey directly after extraction.

Sponsors

Riyadh Colleges of Dentistry and Pharmacy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain day 3on the 3rd dayAssessment of pain by (VAS) from (0, 1, 2,….10).

Secondary

MeasureTime frameDescription
Empty socket day 3on the 3rd dayBy inspection. The socket is empty and does not contain blood clot
Empty socket day 7in the 7th dayBy inspection. The socket is empty and does not contain blood clot
Tenderness within the socket day 3on the 3rd dayBy probing the socket
Tenderness within the socket day 7on the 7th dayBy probing the socket
Pain day 7on the 7th dayAssessment of pain by (VAS) from (0, 1, 2,….10).

Countries

Saudi Arabia

Contacts

Primary ContactHezekiah A Mosadomi, Professor
prof.mosadomi@riyadh.edu.sa00966509995087

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026