Comparison of two different wound-care treatments used after dental extractions to identify if healing was improved and pain reduced
| ISRCTN | ISRCTN14642271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14642271 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsors | Specialist Dental Partners Ltd, Hypo-Stream Ltd |
| Funder | Investigator initiated and funded |
- Submission date
- 16/11/2021
- Registration date
- 26/11/2021
- Last edited
- 15/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Two existing treatments have been used in a specialist clinic following tooth extraction for several years. The level of pain and speed of healing following tooth removal was recorded over a 14 year period and the benefit of the two treatments compared. A treatment using ultra-low concentration chlorinated water reduced the likelihood of dry socket by over 30x and it was concluded that this treatment produced a significant improvement over the other to such an extent that this treatment was adopted exclusively by the clinic.
Who can participate?
Outpatient dental extractions in a specialist dental clinic in the UK between 2000 and 2014.
What does the study involve?
Routine out-patient dental extractions were carried out, and following the extraction, the patient had the site managed with sterile saline mouth-rinse or irrigation of the socket with very low dose aqueous chlorine with saline.
What are the possible benefits and risks of participation?
Both treatments are known and accepted wound-care treatments and adopted for many decades. There was an expectation that there would be a difference in the incidence of alveolar osteitis following extraction. The principal benefit is the prevention of alveolar osteitis and avoidance of antibiotic use and improved antibiotic stewardship.
Where is the study run from?
A private dental specialist clinic near Cambridge (UK)
When is the study starting and how long is it expected to run for?
January 2000 to December 2014.
Who is funding the study?
This is self funded via the clinic as an audit to help improve clinical outcomes for patients.
Who is the main contact?
Dr Myles Dakin, myles.dakin@hypo-stream.com
Contact information
Scientific
Unit 9 Beech House
Melbourn Science Park
Melbourn
Cambridge
SG8 6HB
United Kingdom
 ORCID ID |
0000-0002-0294-4908 |
|---|---|
| Phone | +44 (0)1763261129 |
| mylesdakin@me.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single centre retrospective clinical audit |
| Secondary study design | Case-control study |
| Study type | Participant information sheet |
| Scientific title | Clinical audit of two standard surgical site treatments following dental extractions and the impact on incidence of alveolar osteitis within a specialist dental clinic |
| Study acronym | CAAO |
| Study objectives | There is no difference in post dental extraction healing when two existing wound healing treatments are used. |
| Ethics approval(s) | No ethics approval is required as the study was a retrospective analysis of two existing, licensed wound-care products used in treatment of burns injuries and non-healing leg ulcers. The two treatments are licensed over the counter products and reported on for over four decades. i.e. this is a comparison of two existing OTC wound care formulations. |
| Health condition(s) or problem(s) studied | Post dental extraction alveolar osteitis |
| Intervention | Use of one of two standard, existing, licensed wound-care treatments at time of dental extraction: sterile water rinse plus corsodyl rinse or socket irrigation with very low level hypochlorite in normal saline. Patient records from January 2000 to May 2014 were analysed to audit the use of the above. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Incidence of alveolar osteitis post-operatively measured using patient records at a single time point |
| Key secondary outcome measure(s) |
Satisfactory healing without pain measured using patient records at a single time point |
| Completion date | 20/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | All |
| Target sample size at registration | 934 |
| Total final enrolment | 401 |
| Key inclusion criteria | Patients attending an out-patient dental clinic for non-acute dental extractions. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/06/2000 |
| Date of final enrolment | 01/05/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Melbourn Science Park
Melbourn
Cambridge
SG8 6HB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Myles Dakin, Specialist Dental Partners, Unit 9 Beech House, Melbourn Science Park, Melbourn, Cambridgeshire SG8 6HB. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Preprint results | 14/12/2021 | 15/07/2022 | No | No |
Editorial Notes
15/07/2022: Preprint added.
26/11/2021: Trial's existence confirmed by European Medicines Agency.
