Condition category
Oral Health
Date applied
13/08/2016
Date assigned
16/08/2016
Last edited
16/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Alveolar osteitis (AO) is the most common complication of tooth removal. It occurs when a blood clot fails to develop in the tooth socket, or if the blood clot becomes dislodged or disappears. The empty socket causes severe pain, headaches, fever, and paresthesia (pins and needles). Today, treatments are focused on managing the symptoms and these are not very effective, highlighting the importance of preventing the development of AO. The aim of this study is to assess the effectiveness of chlorhexidine mouthwash after tooth extraction in patients who are at risk of developing AO (previous surgical site infection, traumatic extraction, and tobacco smoking).

Who can participate?
Adults who have undergone tooth extractions and are at risk of developing AO

What does the study involve?
After the tooth extraction, participants are randomly allocated to use either chlorhexidine mouthwash or sterile water for 30 seconds, twice daily for 7 days, starting 24 hours after extraction. After 7 days participants are followed-up to check whether they have developed AO.

What are the possible benefits and risks of participating?
Chlorhexidine mouthwash may reduce the chance of developing AO. The only risk is hypersensitivity (allergic reaction) to chlorhexidine.

Where is the study run from?
Valdivia and Panguipulli, Región de Los Ríos, Chile

When is the study starting and how long is it expected to run for?
June 2012 to December 2015

Who is the main contact?
Dr Diego Halabi
diego.halabi@uach.cl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Diego Halabi

ORCID ID

http://orcid.org/0000-0002-1474-8066

Contact details

Edificio de Ciencias Biomedicas
Facultad de Medicina
Isla Teja
Valdivia
5090000
Chile
+56 (0)63 2293928
diego.halabi@uach.cl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Chlorhexidine 0.12% mouthwash for the prevention of alveolar osteitis after oral surgery: a double-blind randomized clinical trial

Acronym

ChAOP (Chlorhexidine for Alveolar Osteitis Prevention)

Study hypothesis

Chlorhexidine 0.12% mouthwash is better than placebo at preventing alveolar osteitis after oral surgery.

Ethics approval

Research Ethic Committee of Health Community Service of Valdivia, Chile, 22/03/2013, ORD.: Nº 073

Study design

Prospective stratified parallel randomized double-blind placebo-controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Alveolar osteitis (dry socket)

Intervention

Treatment: consisted of a mouthwash with 15 mL chlorhexidine 0.12% (Oralgene® Mouthwash 0.12%, Maver, Chile) for 30 seconds, twice daily for 7 days, starting 24 hours after extraction.
Placebo: Sterile water, with the same indications for use as chlorhexidine.
Chlorhexidine and placebo were stored in similar brown plastic bottles, and instructions were given orally and in writing to each participant.

Patients were randomly allocated to the Chlorhexidine or Placebo group, matched by risk factors, and seven groups were formed with the following possible combinations: smoker, previous infection, traumatic extraction, smoker + previous infection, smoker + traumatic extraction, previous infection + traumatic extraction, previous infection, traumatic extraction. To avoid the risk of having more patients in a group, we stored black envelopes in a box containing a paper with the letter C for chlorhexidine or P for placebo (half of each). For each patient who was assigned to a group, the subsequent patient who arrived with the same risk factors was matched to the opposite group, and the respective envelope was discarded (to ensure homogeneity of groups).

Intervention type

Drug

Phase

Phase IV

Drug names

Chlorhexidine 0.12% mouthwash

Primary outcome measures

Positive diagnosis of alveolar osteitis was identified in patients with the following two characteristics (both variables must be present):
1. Increasing postoperative pain intensity for 4 days within and around the socket: We asked as a dichotomous variable: yes or no. (AO presents with severe pain, therefore, this variable is easily detectable)
2. Total or partial breakdown of the blood clot in the socket with or without bone exposure: like pain, this variable is easy detectable by clinical examination, the clot should completely cover the socket for proper healing
The primary outcome was measured seven days after dental surgery

Secondary outcome measures

N/A

Overall trial start date

01/06/2012

Overall trial end date

27/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with clinical indications for tooth extraction, and who presented at least one of the following risk factors for developing alveolar osteitis:
1. Tobacco smoker (consumption of ≥ 5 cigarettes 24 hrs before extraction)
2. Previous surgical site infection (clinical diagnosis of chronic periodontitis, acute periodontal conditions, apical periodontitis, pericoronitis, fungal infections, or dental pulp gangrene)
3. Traumatic extraction (lifting a flap, use of elevators for > 4 min, and/or rotary instruments)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

744

Participant exclusion criteria

1. Patients requiring extraction in the operating theater
2. Patients living in rural areas who manifested difficulty in returning for follow-up
3. Patients allergic to chlorhexidine
4. Patients under antimicrobial therapy, antibiotic prophylaxis, or antibiotics therapy after extraction

Recruitment start date

01/04/2013

Recruitment end date

27/12/2015

Locations

Countries of recruitment

Chile

Trial participating centre

Dental Emergency Service “ Dr Jorge Sabat Gozalo”
2500, Picarte Street
Valdivia
5090000
Chile

Trial participating centre

Coñaripe Health Comunity Center
Las Tepas S/N
Panguipulli, Valdivia
5210000
Chile

Sponsor information

Organisation

Universidad Austral de Chile

Sponsor details

Campus Isla Teja S/N
Valdivia
5090000
Chile

Sponsor type

University/education

Website

http://www.uach.cl

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are preparing the manuscript for publication before this year ends (2016)

Intention to publish date

27/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes