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Register:	ISRCTN
Last refreshed on:	24 August 2020
Main ID:	ISRCTN20110108
Date of registration:	14/01/2013
Prospective Registration:	Yes
Primary sponsor:	King's College London (UK)
Public title:	Clinical comparison of bioglass air abrasion vs tungsten carbide bur
Scientific title:	An in vivo investigation of the effectiveness of bioactive glass airabrasion vs tungsten carbide bur in the removal of orthodontic resin adhesive
Date of first enrolment:	01/02/2013
Target sample size:	25
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN20110108
Study type:	Interventional
Study design:	Single-centre randomised single-blind controlled clinical trial (Treatment)
Phase:	Not Applicable

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Victoria Klimovich
Address:	Floor 22 Guy's Hospital SE1 9RT London United Kingdom
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Randomly selected patients (male and female patients, age 12-55) requiring fixed orthodontic appliance treatment
2. Able and willing to consent to involvement in the study (speak, read and write English)
3. Must have three front teeth bonded with orthodontic brackets. (Upper left 1, upper left 2, upper right 1)
4. Patients must not have an allergy to silicone impression material
5. Enamel surface must be free from fluorosis / sign of decay / decalcification or sign of enamel damage

Exclusion criteria:
1. Those not meeting inclusion criteria
2. Bracket de-bond and subsequent replacement during treatment of any of the three front teeth (Upper left 1, upper left 2, upper right 1)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Orthodontics
Oral Health
Fitting and adjustment of orthodontic device

Intervention(s)

Visit 1: All patients recruited from the orthodontic clinic. N=25 Participant information sheets given and informed consent gained.
Baseline assessment: N (100%) Clinical assessment, clinical photographs, creation of dental impressions, orthodontic bracket placement.

De-bond visit: N (100%) Bracket removal using conventional technique, dental impressions, clinical photographs.
At the de-bond clinical visit, the orthodontic brackets will be removed in the conventional way, using de-bonding orthodontic pliers. These gently dislodge brackets from the tooth surfaces leaving some of the residual resin cement (glue). The surface roughness (topography) of the teeth will be recorded using conventional medium-bodied silicone dental impressions (moulds) of the three front teeth (upper right central, upper left central, upper left lateral incisors).

The unit of randomisation is the tooth. Randomisation will be stratified by tooth type (UR1, UL1, UL2). For concealment of allocation and blinding purposes, randomisation will be performed centrally, at a different site, by the Biostatistics Unit, King?s College London Dental Institute using a minimisation program and the materials will be coded as Material A and Material B and Material C by an independent operator/pharmacist.

One tooth will have the residual cement removed in the conventional manner using a slow-speed rotary TC bur in a water-cooled hand piece until the surface of the tooth is deemed clinically cement-free using direct vision and tactile use of a dental probe. This procedure will be timed.

Another incisor will have the cement removed using bio-active glass air-abrasion and timed up to the same clinical

Primary Outcome(s)

Change in the volume of enamel (in microns cubed) measured once the impressions, which are taken at the baseline and de-bond visit, are poured up in stone and scanned by laser profilometer in the laboratory.

Secondary Outcome(s)

Roughness (Ra) measured once the impressions, which are taken at the baseline and de-bond visit, are poured up in stone and scanned by laser profilometer in the laboratory.

Secondary ID(s)

N/A

Source(s) of Monetary Support

King’s College London

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Westminster Research Ethics Committee, 16/12/2012, ref: 12/LO/0946

Results

Results available:	Yes
Date Posted:
Date Completed:	30/09/2014
URL:

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