A randomised controlled trial evaluating the impact of oral health advice on gingival health using intra oral images combined with a gingivitis specific toothpaste.

Objectives: Does a complex intervention of oral hygiene advice (OHA) delivered with intra-oral scanner images, anti-gingivitis toothpaste and motivational reminders, improve oral health more than a standard of care control arm of fluoride toothpaste, with OHA without scanner images?

Methods: Adult participants with pre-existing gingivitis were randomised to intervention or control. Following enrolment, baseline and each subsequent visit (V) (3-weeks, V2; 3-months, V3; 6-months, V4) followed the same schedule. Bleeding on Probing (BOP) was assessed and Intra Oral Scan IOS(1) recorded.

Antigingivitis efficacy of a sodium bicarbonate toothpaste: Pooled analysis.

Objective: The objective of this study was to investigate the antigingivitis and antiplaque treatment effect of a toothpaste containing 67% w/w sodium bicarbonate, at the individual tooth site, tooth region and whole mouth (overall) level, by way of a pooled analysis of data from similarly designed clinical trials.

Methods: Six randomized controlled GSKCH clinical trials, 12-24 weeks in duration, were selected based on pre-specified criteria which included access to patient level data, pre-treatment dental prophylaxis, >20 bleeding sites and mild-moderate gingivitis at screening and use of 67% sodium bicarbonate toothpaste and non-sodium bicarbonate (regular) toothpaste (negative control) for ≥4 weeks. Efficacy outcomes comprised plaque index (TPI), modified gingival index (MGI) and gingival bleeding (bleeding index (BI), number of bleeding sites (BS)).

Randomised study of intra-oral kinetics of fluoride-containing toothpastes.

Objectives: This randomised, controlled, analyst blind, crossover study aimed to evaluate and compare salivary fluoride and calcium ion concentration over 60 min following brushing with an assigned treatment and following an orange juice (OJ) or deionised (DI) water rinse 60 min post-brushing.

Methods: Study treatments, both containing 1150 ppm fluoride as NaF and 5% w/w KNO, were the Test (including 1.2 % w/w cocamidopropyl betaine) and Comparator (including tetrasodium pyrophosphate and sodium lauryl sulphate) toothpastes.

A proof of concept study to confirm the suitability of an intra oral scanner to record oral images for the non-invasive assessment of gingival inflammation.

Objectives: To compare gingival inflammation scores obtained chairside using the non-invasive modified gingival index (MGI) with MGI scores from an intraoral scan (IOS) captured at the clinical visit but viewed 10 days later.

Methods: Single visit, anterior teeth, observational, proof of concept study in healthy adult participants with a spectrum of gingival inflammation. One investigator performed both clinical and intraoral scan MGI assessments, a second repeated the MGI evaluation from the IOS.

A randomised oral fluoride retention study comparing intra-oral kinetics of fluoride-containing dentifrices before and after dietary acid exposure.

Objective: This exploratory, randomised, single-blind, crossover, study evaluated fluoride and calcium ion concentrations and pH following use of one of two 1450 ppm fluoride (NaF), 5% w/w KNO dentifrices: (1) test dentifrice (with cocamidopropyl betaine) with an orange juice (OJ) rinse; (2) test dentifrice with a deionized (DI) water rinse or (3) comparator dentifrice (with sodium lauryl sulphate and tetrasodium pyrophosphate) with an OJ rinse.

Design: Eighteen participants used their assigned dentifrice, rinsed with DI water, then expectorate was collected. Sixty min post-brushing, participants rinsed with OJ or DI water then expectorate was collected.

Randomized Clinical Dose-Response Study to Evaluate Plaque Removal by Three Experimental Sodium Bicarbonate Toothpastes Using a Single Brushing Model.

Objectives: This randomized, examiner-blind, crossover clinical study compared the plaque removal efficacy of three experimental toothpastes containing 20%, 35%, and 50% w/w sodium bicarbonate (NaHCO3) with commercial toothpastes containing 67% and 0% w/w NaHCO3 (positive and negative controls, respectively).

Methods: Fifty-six adults with a mean Turesky Modification of the Quigley-Hein Plaque Index (TPI) score of = 2.00 at screening and at the first treatment visit (pre-brushing) were randomized to a supervised single, timed (one minute) brushing with a 0%, 20%, 35%, 50%, or 67% w/w NaHCO3-containingtoothpaste.

Dentin hypersensitivity monitored by cold air quantitative sensory testing.

Background: Quantification of dentin hypersensitivity (DH) is challenging and requires standardised, graded stimulation by natural-like stimuli.

Objective: The present study aimed at identifying DH subjects and longitudinally monitoring their pain thresholds by cold air quantitative sensory testing (QST).

Methods: Subject recruitment started with an online DH questionnaire.

A 24-week randomized clinical study investigating the anti-gingivitis efficacy of a 0.454% w%#47;w stannous fluoride dentifrice.

Purpose: To evaluate and compare gingival health, as measured by a bleeding index (BI), a modified gingival index (MGI), a dental plaque index (PI), and number of bleeding sites following twice daily use of an anhydrous 0.454% weight/weight (w/w) stannous fluoride dentifrice (Test Dentifrice) compared to a sodium monofluorophosphate (SMFP) dentifrice (Negative Control) over 24 weeks.

Methods: This was a single-center, examiner-blinded, randomized [by gender and baseline mean MGI score (Low ≤ 2.

A 12-week randomized clinical study investigating the anti-gingivitis efficacy of a 0.454% w/w stannous fluoride dentifrice.

Purpose: To evaluate and compare gingival health, as measured by a bleeding index (BI), a modified gingival index (MGI), number of bleeding sites, and blood in expectorate following twice daily use of a non-aqueous 0.454% weight/weight (w/w) stannous fluoride dentifrice ('Test dentifrice') compared to a sodium monofluorophosphate (SMFP) dentifrice (' Negative Control') over 12 weeks, in subjects with moderate gingivitis and gingival bleeding following tooth brushing.

Methods: This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 12-week clinical study in healthy adult volunteers with moderate gingivitis who demonstrated gingival bleeding following tooth brushing.

Effect of phytate and zinc ions on fluoride toothpaste efficacy using an in situ caries model.

Objectives: To compare and explore the dose-response of phytate-containing 1150 ppm fluoride toothpastes on model caries lesions and to determine the impact of zinc ions.

Methods: This was a single-centre, randomised, blinded (examiner/laboratory analyst), six-treatment, four-period crossover, in situ study in adults with a removable bilateral maxillary partial denture. Study treatments were toothpastes containing: 0.

Effects of a sodium fluoride- and phytate-containing dentifrice on remineralisation of enamel erosive lesions-an in situ randomised clinical study.

Objective: The objective of this work was to evaluate effects of a dentifrice containing sodium fluoride (1150 ppm F) and the organic polyphosphate phytate (0.85% w/w of the hexa-sodium salt) on in situ remineralisation of early enamel erosive lesions and resistance to subsequent demineralisation.

Materials And Methods: Subjects (n = 62) wore palatal appliances holding eight bovine enamel specimens with pre-formed erosive lesions.

An in-situ pilot study to investigate the native clinical resistance of enamel to erosion.

Objectives: To investigate the differences in susceptibility of the surface of native and polished enamel to dietary erosion using an in-situ model.

Methods: Thirty healthy volunteers (n = 10 per group) wore mandibular appliances containing 2 native and 2 polished enamel samples for 30 min after which, the samples were exposed to either an ex-vivo or in-vivo immersion in orange juice for 5, 10 or 15 min and the cycle repeated twice with an hour's interval between them. Samples were scanned with a non-contacting laser profilometer and surface roughness was extracted from the data, together with step height and microhardness change on the polished enamel samples.

A randomised clinical evaluation of a fluoride mouthrinse and dentifrice in an in situ caries model.

Objectives: Fluoride mouthrinses provide advantages for fluoride delivery by maintaining elevated intra-oral fluoride concentrations following fluoride dentifrice use. This in situ caries study investigated potential anti-caries efficacy of a 220 ppm fluoride mouthrinse.

Methods: This was an analyst-blinded, four-treatment, randomised, crossover study using partially demineralised, gauze-wrapped, human enamel samples mounted in a mandibular partial denture.

Measurement of surface roughness changes of unpolished and polished enamel following erosion.

Objectives: To determine if Sa roughness data from measuring one central location of unpolished and polished enamel were representative of the overall surfaces before and after erosion.

Methods: Twenty human enamel sections (4x4 mm) were embedded in bis-acryl composite and randomised to either a native or polishing enamel preparation protocol. Enamel samples were subjected to an acid challenge (15 minutes 100 mL orange juice, pH 3.

Randomized Controlled Trial to Explore the Effect of Experimental Low Abrasivity Dentifrices on Enamel Gloss and Smoothness, and the Build-up of Extrinsic Tooth Stain.

Objectives: To evaluate and compare examiner-assessed changes in enamel gloss, extrinsic dental stain, and surface smoothness following one, two, four, and eight weeks of twice-daily use of an experimental low abrasivity desensitizing dentifrice (relative dentin abrasivity [RDA] ~40) containing 5% sodium tripolyphosphate (STP) chemical cleaning agent and 1% aluminum trioxide abrasive. This was compared with an ultra-low abrasivity dentifrice (5% STP only; RDA ~13), a moderate abrasivity fluoride dentifrice (RDA ~80), and a higher abrasivity marketed whitening dentifrice (RDA ~142).

Methods: This was a single-center, examiner-blind, randomized, controlled, parallel group study in healthy adults stratified by gloss score and age.

A Randomized Clinical Trial Investigating the Effect of Particle Size of Calcium Sodium Phosphosilicate (CSPS) on the Efficacy of CSPS-containing Dentifrices for the Relief of Dentin Hypersensitivity.

Objectives: To investigate the effect of reducing the particle size of calcium sodium phosphosilicate (CSPS) bioactive glass from ~14 µm (NovaMin®) to ~4 µm (Vitryxx®), and of changing the fluoride source in a 5% CSPS dentifrice from sodium monofluorophosphate (SMFP) to sodium fluoride (NaF) on the efficacy of CSPS-containing dentifrices in dentin hypersensitivity (DH) relief.

Methods: A randomized, controlled, examiner-blind, five-treatment arm, parallel group, stratified, exploratory study of NaF dentifrices containing 2.5% or 5% small particle size CSPS (~4 µm), NaF or SMFP dentifrices containing 5% CSPS (~14 µm), and a regular fluoride dentifrice in healthy subjects with DH.

Randomised clinical trial to evaluate changes in dentine tubule occlusion following 4 weeks use of an occluding toothpaste.

Objectives: The objective of this study is to determine whether a silicone impression material could precisely replicate dentine tubule changes following 4 weeks toothbrushing with occluding or non-occluding toothpaste and whether changes reflected hypersensitivity clinical assessment.

Materials And Methods: This was a single site, examiner blind, parallel, two treatment arm, randomised clinical trial. Participants were healthy, ≥18, with ≥1 sensitive tooth with exposed dentine, Schiff sensitivity score ≥2, and patent tubules with dentine occlusion score 4-5 as determined by scanning electron microscopy of replica impressions.

Anticaries Potential of a Sodium Monofluorophosphate Dentifrice Containing Calcium Sodium Phosphosilicate: Exploratory in situ Randomized Trial.

Calcium sodium phosphosilicate (CSPS) is a bioactive glass material that alleviates dentin hypersensitivity and is postulated to confer remineralization of caries lesions. This single-centre, randomized, single (investigator)-blind, placebo-controlled, crossover, in situ study explored whether the addition of 5% CSPS to a nonaqueous fluoride (F) such as sodium monofluorophosphate (SMFP)-containing dentifrice affects its cariostatic ability. Seventy-seven subjects wore 4 gauze-covered enamel specimens with preformed lesions (2 surface-softened and 2 subsurface) placed buccally on their mandibular bilateral dentures for up to 4 weeks.

T relaxation mapping MRI of healthy and inflamed gingival tissue.

Objectives: To investigate the use and reproducibility of MRI transverse relaxation time (T) mapping in healthy and inflamed gingivae.

Methods: 21 subjects were recruited into 2 groups: those without evidence of gingivitis ("healthy"; n = 11, age 24.0 ± 3.

Novel Air Stimulation MR-Device for Intraoral Quantitative Sensory Cold Testing.

The advent of neuroimaging in dental research provides exciting opportunities for relating excitation of trigeminal neurons to human somatosensory perceptions. Cold air sensitivity is one of the most frequent causes of dental discomfort or pain. Up to date, devices capable of delivering controlled cold air in an MR-environment are unavailable for quantitative sensory testing.

Three randomized clinical trials to assess the short-term efficacy of anhydrous 0.454% w/w stannous fluoride dentifrices for the relief of dentin hypersensitivity.

Purpose: To assess the short-term efficacy of dentifrices containing 0.454% weight/weight (w/w) stannous fluoride applied using a focused brushing methodology for the relief of dentin hypersensitivity (DH).

Methods: Three randomized, examiner blind, controlled, two treatment arm, parallel group studies were conducted utilizing a novel application method in which, prior to brushing the whole mouth, the stannous fluoride dentifrice was applied to two sensitive teeth by focused brushing.

Strontium effects on root dentin tubule occlusion and nanomechanical properties.

Objectives: Dentin hypersensitivity often is treated by promotion of dentin tubule occlusion. In this in vitro study we evaluated nanomechanical properties and degree of tubule occlusion conferred to sound and demineralized human root dentin following treatment with a 10% (w/w) strontium acetate solution and its relation to the treatment duration and delivery method.

Methods: 24 human cervical root dentin disks (8 groups of 3) were polished through 0.

Confirmation of efficacy in providing relief from the pain of dentin hypersensitivity of an anhydrous dentifrice containing 0.454% with or without stannous fluoride in an 8-week randomized clinical trial.

Purpose: To compare the efficacy of an anhydrous dentifrice containing 0.454% w/w stannous fluoride and a negative control dentifrice containing 1,000 ppm fluoride, as sodium monofluorophosphate, at reducing dentin hypersensitivity over 8 weeks with twice-daily brushing.

Methods: This was a randomized, examiner-blind, parallel, two treatment group, stratified (by maximum baseline Schiff sensitivity score), 8-week clinical study carried out at a single site in 119 healthy subjects with at least two sensitive teeth, who met all study criteria at the screening and baseline visits.

A randomised clinical trial investigating calcium sodium phosphosilicate as a dentine mineralising agent in the oral environment.

Objective: The ability of a dentifrice containing the bioactive material calcium sodium phosphosilicate (CSPS) to remineralise the surface of dentine and physically occlude patent tubules was investigated in a 20 day in situ randomised clinical study.

Methods: Changes in surface microhardness and surface topography of dentine specimens treated for 5, 10, 15 and 20 days, twice daily with either a dentifrice containing 5% CSPS or a fluoride-only containing placebo dentifrice were compared. The substantivity of any mineral deposits formed on the surface of dentine were investigated by the application of an intra-oral dietary acid challenge twice daily during the final 10 days of treatment.

A randomized clinical study investigating the staining profile of an experimental stannous fluoride dentifrice.

Purpose: The primary objective of this study was to investigate the staining profile of an experimental test dentifrice containing 0.454% w/w stannous fluoride compared to that of a marketed control dentifrice containing 0.76% w/w sodium monofluorophosphate (Colgate Cavity Protection) following regular and repeat use, with twice daily brushing over 8 weeks.