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

NCT ID: NCT02678104

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Dry Socket

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Chlorhexidine mouth wash

Tooth extraction. The patients will start using Chlorhexidine mouthwash on 2nd day of extraction twice daily for 7 days.

Group Type EXPERIMENTAL

Tooth extraction

Intervention Type PROCEDURE

Tooth removal

Chlorhexidine mouth wash

Intervention Type DRUG

Chlorhexidine mouth wash

Manuka Honey

intra-alveolar application of Manuka Honey after tooth extraction.

Group Type EXPERIMENTAL

Tooth extraction

Intervention Type PROCEDURE

Tooth removal

Intra-alveolar application of Manuka Honey

Intervention Type DRUG

Intra-alveolar application of Manuka Honey directly after extraction.

Interventions

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Tooth extraction

Tooth removal

Intervention Type PROCEDURE

Chlorhexidine mouth wash

Chlorhexidine mouth wash

Intervention Type DRUG

Intra-alveolar application of Manuka Honey

Intra-alveolar application of Manuka Honey directly after extraction.

Intervention Type DRUG

Other Intervention Names

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Oraxine 0.2% Chlorhexidine mouth wash Marks & Spencer Manuka Honey

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riyadh Colleges of Dentistry and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Nedal Abu-Mostafa

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nedal A Abu Mostafa, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Riyadh Colleges of Dentistry and Pharmacy

Locations

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RiyadH Colleges of dentistry and Pharmacy

Riyadh, Riyadh Region, Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Hezekiah A Mosadomi, Professor

Role: CONTACT

00966509995087

Facility Contacts

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Hezekiah A. Mosadomi, Professor

Role: primary

References

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Abu-Mostafa NA, Alqahtani A, Abu-Hasna M, Alhokail A, Aladsani A. A randomized clinical trial compared the effect of intra-alveolar 0.2 % Chlorohexidine bio-adhesive gel versus 0.12% Chlorohexidine rinse in reducing alveolar osteitis following molar teeth extractions. Med Oral Patol Oral Cir Bucal. 2015 Jan 1;20(1):e82-7. doi: 10.4317/medoral.19932.

Reference Type BACKGROUND
PMID: 25475768 (View on PubMed)

Alexander RE. Dental extraction wound management: a case against medicating postextraction sockets. J Oral Maxillofac Surg. 2000 May;58(5):538-51. doi: 10.1016/s0278-2391(00)90017-x. No abstract available.

Reference Type BACKGROUND
PMID: 10800910 (View on PubMed)

Bloomer CR. Alveolar osteitis prevention by immediate placement of medicated packing. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Sep;90(3):282-4. doi: 10.1067/moe.2000.108919.

Reference Type BACKGROUND
PMID: 10982947 (View on PubMed)

Caso A, Hung LK, Beirne OR. Prevention of alveolar osteitis with chlorhexidine: a meta-analytic review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Feb;99(2):155-9. doi: 10.1016/j.tripleo.2004.05.009.

Reference Type BACKGROUND
PMID: 15660084 (View on PubMed)

Efem SE. Clinical observations on the wound healing properties of honey. Br J Surg. 1988 Jul;75(7):679-81. doi: 10.1002/bjs.1800750718.

Reference Type BACKGROUND
PMID: 3416123 (View on PubMed)

Jull AB, Cullum N, Dumville JC, Westby MJ, Deshpande S, Walker N. Honey as a topical treatment for wounds. Cochrane Database Syst Rev. 2015 Mar 6;2015(3):CD005083. doi: 10.1002/14651858.CD005083.pub4.

Reference Type BACKGROUND
PMID: 25742878 (View on PubMed)

Nasir NA, Halim AS, Singh KK, Dorai AA, Haneef MN. Antibacterial properties of tualang honey and its effect in burn wound management: a comparative study. BMC Complement Altern Med. 2010 Jun 24;10:31. doi: 10.1186/1472-6882-10-31.

Reference Type BACKGROUND
PMID: 20576085 (View on PubMed)

Pieper B. Honey-based dressings and wound care: an option for care in the United States. J Wound Ostomy Continence Nurs. 2009 Jan-Feb;36(1):60-6; quiz 67-8. doi: 10.1097/01.WON.0000345177.58740.7d.

Reference Type BACKGROUND
PMID: 19155824 (View on PubMed)

Singh V, Pal US, Singh R, Soni N. Honey a sweet approach to alveolar osteitis: A study. Natl J Maxillofac Surg. 2014 Jan;5(1):31-4. doi: 10.4103/0975-5950.140166.

Reference Type BACKGROUND
PMID: 25298714 (View on PubMed)

Atwa AD, AbuShahba RY, Mostafa M, Hashem MI. Effect of honey in preventing gingivitis and dental caries in patients undergoing orthodontic treatment. Saudi Dent J. 2014 Jul;26(3):108-14. doi: 10.1016/j.sdentj.2014.03.001. Epub 2014 Apr 19.

Reference Type RESULT
PMID: 25057231 (View on PubMed)

Other Identifiers

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FRP/2016/23

Identifier Type: -

Identifier Source: org_study_id

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