NCT02678104

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

January 24, 2016

Last Update Submit

March 13, 2017

Conditions

Dry Socket

Keywords

Dry SocketHoneyTooth Extraction

Outcome Measures

Primary Outcomes (1)

  • Pain day 3

    Assessment of pain by (VAS) from (0, 1, 2,….10).

    on the 3rd day

Secondary Outcomes (5)

  • Empty socket day 3

    on the 3rd day

  • Empty socket day 7

    in the 7th day

  • Tenderness within the socket day 3

    on the 3rd day

  • Tenderness within the socket day 7

    on the 7th day

  • Pain day 7

    on the 7th day

Study Arms (2)

Chlorhexidine mouth wash

EXPERIMENTAL

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

Procedure: Tooth extractionDrug: Chlorhexidine mouth wash

Manuka Honey

EXPERIMENTAL

intra-alveolar application of Manuka Honey after tooth extraction.

Procedure: Tooth extractionDrug: Intra-alveolar application of Manuka Honey

Interventions

Tooth extractionPROCEDURE

Tooth removal

Chlorhexidine mouth washManuka Honey
Chlorhexidine mouth washDRUG

Chlorhexidine mouth wash

Also known as: Oraxine 0.2% Chlorhexidine mouth wash
Chlorhexidine mouth wash
Intra-alveolar application of Manuka HoneyDRUG

Intra-alveolar application of Manuka Honey directly after extraction.

Also known as: Marks & Spencer Manuka Honey
Manuka Honey

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who have extraction of single molar tooth

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RiyadH Colleges of dentistry and Pharmacy

Riyadh, Riyadh Region, 11681, Saudi Arabia

RECRUITING

Related Publications (10)

  • 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.

    PMID: 25475768BACKGROUND

  • 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.

    PMID: 10800910BACKGROUND

  • 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.

    PMID: 10982947BACKGROUND

  • 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.

    PMID: 15660084BACKGROUND

  • 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.

    PMID: 3416123BACKGROUND

  • 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.

    PMID: 25742878BACKGROUND

  • 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.

    PMID: 20576085BACKGROUND

  • 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.

    PMID: 19155824BACKGROUND

  • 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.

    PMID: 25298714BACKGROUND

  • 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.

    PMID: 25057231RESULT

MeSH Terms

Conditions

Dry Socket

Interventions

Tooth Extraction

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Nedal A Abu Mostafa, Lecturer

    Riyadh Colleges of Dentistry and Pharmacy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hezekiah A Mosadomi, Professor

CONTACT

00966509995087prof.mosadomi@riyadh.edu.sa

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 24, 2016

First Posted

February 9, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

March 14, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)