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

R

Riyadh Colleges of Dentistry and Pharmacy

Status and phase

Unknown
Phase 2

Conditions

Dry Socket

Treatments

Drug: Intra-alveolar application of Manuka Honey
Procedure: Tooth extraction
Drug: Chlorhexidine mouth wash

Study type

Interventional

Funder types

Other

Identifiers

NCT02678104
FRP/2016/23

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Chlorhexidine mouth wash
Experimental group
Description:
Tooth extraction. The patients will start using Chlorhexidine mouthwash on 2nd day of extraction twice daily for 7 days.
Treatment:
Drug: Chlorhexidine mouth wash
Procedure: Tooth extraction
Manuka Honey
Experimental group
Description:
intra-alveolar application of Manuka Honey after tooth extraction.
Treatment:
Procedure: Tooth extraction
Drug: Intra-alveolar application of Manuka Honey

Trial contacts and locations

1

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Central trial contact

Hezekiah A Mosadomi, Professor

Data sourced from clinicaltrials.gov

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