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

March 13, 2017 updated by: Nedal Abu-Mostafa, Riyadh Colleges of Dentistry and Pharmacy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riyadh Colleges of Dentistry and Pharmacy

Investigators

  • Principal Investigator: Nedal A Abu Mostafa, Lecturer, Riyadh Colleges of Dentistry and Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

January 24, 2016

First Submitted That Met QC Criteria

February 4, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRP/2016/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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