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21 March 2013
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| [ Print-friendly version ] |
| Clinical comparison of bioglass air abrasion vs tungsten carbide bur |
| ISRCTN | ISRCTN20110108 |
| DOI | 10.1186/ISRCTN20110108 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Clinical comparison of bioglass air abrasion vs tungsten carbide bur |
| Scientific title | An invivo investigation of the effectiveness of bioactive glass airabrasion vs tungsten carbide bur in the removal of orthodontic resin adhesive |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | Null hypothesis: Bio-active glass air-abrasion has no significant beneficial, self-limiting effect over using alumina powder or tungsten carbide (TC) bur in a hand piece, the clinical orthodontic gold standard, when removing residual orthodontic resin adhesive after debonding brackets clinically. |
| Lay summary | Lay summary under review 2 |
| Ethics approval | Westminster Research Ethics Committee, 16/12/12, ref: 12/LO/0946 |
| Study design | Single-centre randomised single-blind controlled clinical trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Orthodontics |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 01/02/2013 |
| Anticipated end date | 30/09/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please contact Victoria Klimovich (k1185315@kcl.ac.uk) to request a patient information sheet |
| Target number of participants | 25 |
| Interventions |
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 endpoint. Finally, the third incisor will be treated with alumina powder and timed. Subsequently, two impressions of the teeth will be taken. The first one will be discarded due to debris contamination from the procedure. The second dental impression will be used to assess the final surface topography. Close-up standardised digital photographs of these three incisors will be taken pre and post resin cement removal. Cement from the remaining teeth will be removed in the conventional way using the TC bur. Group A Test material (Bioglass) N=25 Group B Negative control material (Alumina powder) N=25 Group C Control material (TC bur) N=25 Each procedure will be timed. Final assessment: N (100%) Visual examination of treated enamel, clinical photographs, creation of dental impressions. Extra clinical work carried out will add 10-15 minutes to the overall appointment time with no other interventions required. The impressions will be disinfected and poured at Guy’s hospital. Dental stone replicas produced from the impressions will be scanned quantitatively using a laser profilometer, to assess precisely how much material is removed by each technique. Retainers will be provided as normal with retainer review appointments arranged every 3 months for the 1st year then every 6 months for the 2nd year post treatment. Patients can obtain results of the trial once they become available at their retainer review appointment. |
| Primary outcome measure(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 measure(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. |
| Sources of funding | King’s College London (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Victoria Klimovich |
| Address |
Floor 22
Guys Hospital |
| City/town | London |
| Zip/Postcode | SE1 9RT |
| Country | United Kingdom |
| Sponsor | King's College London (UK) |
| Address |
c/o Keith Brenan
Room 1.8 Hodgkin Building Guy's Campus |
| City/town | London |
| Zip/Postcode | SE1 4UL |
| Country | United Kingdom |
| Sponsor website: | http://www.kcl.ac.uk |
| Date applied | 03/01/2013 |
| Last edited | 14/01/2013 |
| Date ISRCTN assigned | 14/01/2013 |
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