title: Randomized controlled trial to study plaque inhibition in calcium sodium phosphosilicate dentifrices.
abstract: OBJECTIVE
  To evaluate the effect of three calcium sodium phosphosilicate (CSPS)/sodium monofluorophosphate containing dentifrices, compared to positive and negative controls on plaque re-growth in a non-brushing model, after 4 days of twice daily use, as determined by plaque area and Turesky plaque index (TPI).
  
  
  METHODS
  This was an exploratory, single-centre, examiner-blind, randomised, controlled, five treatment period, crossover, plaque re-growth study, with supervised use of study products. Twenty-three healthy adult volunteers were randomized to receive experimental 5% CSPS dentifrice; two marketed 5% CSPS dentifrices; active comparator mouthrinse and negative control dentifrice. At the start of each treatment period, zero plaque was established by dental prophylaxis and study products were dispensed as either dentifrice slurries or mouthrinse, twice daily for the next 4 days. No other forms of oral hygiene were permitted. After 96h, supra-gingival plaque was determined by plaque area (direct entry, planimetric method) and TPI. Changes from zero plaque were analysed.
  
  
  RESULTS
  For both measures, plaque re-growth at 96h was significantly lower following treatment with active comparator mouthrinse and significantly higher following treatment with the experimental 5% CSPS dentifrice, compared to all other treatments. There were no statistically significant differences between the three other treatments, except between the marketed 5% CSPS dentifrices, for overall plaque area.
  
  
  CONCLUSIONS
  The comparator mouthwash was significantly more effective at preventing plaque accumulation than the dentifrice slurries. The three marketed dentifrices contained sodium lauryl sulphate and were more effective at reducing plaque re-growth than the experimental dentifrice formulated with a tegobetaine/adinol surfactant system.
  
  
  CONCLUSIONS
  The CSPS containing dentifrices tested in this study showed no significant chemical-therapeutic anti-plaque benefits compared to a negative control dentifrice. However, sodium lauryl sulphate-containing dentifrices controlled plaque more effectively than a tegobetaine/adinol-containing CSPS dentifrice suggesting that the impact of surfactant selection on anti-plaque activity of formulations warrants further investigation.
authors.affiliation: Periodontology, Clinical Trials Unit, Bristol Dental School, Lower Maudlin Street, Bristol BS1 2LY, UK. Electronic address: N.Claydon@bristol.ac.uk.
authors.forename: Nicholas C A
authors.initials: NC
authors.lastname: Claydon
authors.affiliation: GSK Consumer Healthcare, St. George's Avenue, Weybridge KT13 0DE, UK. Electronic address: Claire.x.hall@gsk.com.
authors.forename: Claire
authors.initials: C
authors.lastname: Hall
authors.affiliation: GSK Consumer Healthcare, St. George's Avenue, Weybridge KT13 0DE, UK. Electronic address: Alison.J.Hughes@gsk.com.
authors.forename: Alison J
authors.initials: AJ
authors.lastname: Hughes
authors.affiliation: inVentiV Health, Thames House, 17 Marlow Road, Maidenhead SSL6 7AA, UK. Electronic address: David.2.Shaw@gsk.com.
authors.forename: David
authors.initials: D
authors.lastname: Shaw
authors.affiliation: Periodontology, Clinical Trials Unit, Bristol Dental School, Lower Maudlin Street, Bristol BS1 2LY, UK. Electronic address: J.Seong@bristol.ac.uk.
authors.forename: Joon
authors.initials: J
authors.lastname: Seong
authors.affiliation: Periodontology, Clinical Trials Unit, Bristol Dental School, Lower Maudlin Street, Bristol BS1 2LY, UK. Electronic address: Maria.Davies@bristol.ac.uk.
authors.forename: Maria
authors.initials: M
authors.lastname: Davies
authors.affiliation: Periodontology, Clinical Trials Unit, Bristol Dental School, Lower Maudlin Street, Bristol BS1 2LY, UK. Electronic address: N.X.West@bristol.ac.uk.
authors.forename: Nicola X
authors.initials: NX
authors.lastname: West
mesh_terms: D000328:Adult; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D002130:Calcium Phosphates / Q000737:chemistry / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003773:Dental Plaque / Q000188:drug therapy* / Q000517:prevention & control; D003774:Dental Plaque Index; D003802:Dentifrices / Q000627:therapeutic use*; D005260:Female; D005459:Fluorides / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000627:therapeutic use; D009910:Oral Hygiene; D010710:Phosphates / Q000627:therapeutic use; D016037:Single-Blind Method; D012967:Sodium Dodecyl Sulfate / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000891:Anti-Infective Agents, Local; D002130:Calcium Phosphates; D003802:Dentifrices; D009067:Mouthwashes; D010710:Phosphates; C012980:fluorophosphate; D012967:Sodium Dodecyl Sulfate; C076375:rhenanite; D005459:Fluorides
keywords: Calcium sodium phosphosilicate (CSPS); Novamin(®); Planimetry; Plaque