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. Plaque was disclosed, scored and re-scanned (IOS(2)). The intervention group received OHA with IOS images, control group receiving OHA without IOS images. Participants brushed with their allocated toothpaste (fluoride, control; anti-gingivitis, intervention), IOS(3) was recorded. Between visits participants brushed with their allocated toothpaste, intervention group received motivational reminders. RESULTS: BOP scores from baseline were significantly improved in the intervention group compared to control at all visits for all surfaces (p<0.001); differences at V4 were 0.292 (all), 0.211 (buccal/labial) and 0.375 (lingual/palatal). Plaque scores from baseline pre-brushing to each visit pre- and post-brushing also favoured the intervention group, the difference always significant on lingual/palatal surfaces (p<0.05), significant for all but pre-brushing-V4 (p<0.05) on all surfaces, but only significant for pre-brushing-V3 (p<0.05) buccally/labially. Differences from baseline to post-brushing at V4 were: 0.200 (all), 0.098 (buccal/labial) and 0.291 (lingual/palatal). CONCLUSION: A complex intervention comprising OHA delivered with IOS-images, anti-gingivitis toothpaste and motivational reminders improved gingival health more than existing standard of care-OHA together with a standard fluoride toothpaste over a 6-month period. CLINICAL SIGNIFICANCE STATEMENT: Intra-oral scans (IOS) are now frequently used in general dental practice for a variety of purposes. IOS use, in combination with motivational texts and an anti-gingivitis toothpaste, could be further deployed to promote oral hygiene behaviour change in patients and improve gingival health, in a cost-effective manner.

Randomised controlled trial of a microneedle patch with a topical anaesthetic for relieving the pain of dental injections.

OBJECTIVES: To determine whether a microneedle patch combined with 5% topical lidocaine reduces dental injection pain more than a patch without microneedles combined with 5% topical lidocaine. METHODS: This proof of principle randomised, two-treatment, double-blind, crossover split-unit design study in 16 healthy participants investigated levels of perceived pain from 3 increasing pain provoking challenges, when topical 5% lidocaine dental gel was applied to the oral mucosa with a microneedle patch and a patch with no microneedles, prior to infiltration with local anaesthesia on 2 visits. Pain was assessed by visual analogue scale (VAS) and 4-point verbal rating scale (VRS). RESULTS: 15 participants completed the study. Mean pain scores, lower at buccal sites, increased in both groups across challenges 1-3: Test palatal 5.1, 11.9, 26.8; buccal 0.7, 2.8, 18.3; Control palatal 12.3, 18.7, 39.5; buccal 4.0, 6.9, 30.6. The microneedle patch plus lidocaine significantly lowered VAS pain scores at both sites for all challenges, the biggest mean difference seen palatally after challenge 3 (12.7, p < 0.001). VRS pain scores were also significantly reduced for test compared to control for all 3 challenges (p = 0.014). Buccal scores favoured the microneedle patch, significantly for pain challenge 3 (p = 0.025). No adverse events occurred. CONCLUSIONS: Prior oral application of a microneedle patch combined with 5% topical lidocaine gel reduced the pain experienced from dental infiltration. Microneedle patch use in the dental setting offers the prospect of improving degree and depth of anaesthesia from topically applied anaesthetic gel, without itself causing any pain. CLINICAL SIGNIFICANCE: Dental injections are associated with fear and anxiety. Application of a microneedle patch, combined with topical anaesthetic, to the oral mucosa prior to delivery of the injection reduces the pain from this dental procedure. This novel technique may allay patients' apprehension of local anaesthesia and improve quality of life outcomes.

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. RESULTS: 23 participants aged 18-72 yielded data for 552 gingival sites. There was agreement at 90 % of sites comparing clinical with IOS MGI scores. The commonest disagreements were MGI grade 0 read as 1 and 2 read as 3, the highest single probability of error occurring where a clinical score of 0 was scored 1 from the IOS: 0.118 and 0.129 for examiners 1 and 2 respectively. The second most common probability of error occurred where an IOS score of 3 was scored clinically as 2: 0.089 and 0.097 for examiners 1 and 2 respectively. MGI scores from the scans were similar for both examiners (91 % agreement), with no discrepancies of greater than 1 scale point. There was very close agreement between clinical MGI and IOS colour/texture scores. CONCLUSION: This study conclusively demonstrated that the MGI score from the scanned image was very similar to the MGI scored clinically. This study confirms that a digital IOS accurately captures gingival contour images allowing a clinician to determine health or degree of gingival inflammation from it using MGI scores. CLINICAL SIGNIFICANCE STATEMENT: This study confirms that IOS images of teeth and soft tissues are sufficiently accurate to allow the clinical evaluation of health or inflammatory gingival status using non-invasive indices. IOS has great potential for efficient and accurate data capture, for general practice and research facilitating remote evaluation and data verification.

A novel cervical tooth wear and recession index, the cervical localisation code, and its application in the prevention and management of dentine hypersensitivity.

OBJECTIVES: To design and validate a new index to assess tooth wear (TW) in the cervical region and its association with gingival recession (GR), for use both in research studies and as resource in General Dental Practice, with focused prevention and management strategiesparticularly related to aetiology of dentine hypersensitivity provided for each Code score. METHODS: Codes to reflect clinical presentations of the cervical region in health and disease recording both TW and GR were defined. Validation of the Code was undertaken by 3 trained examiners who scored buccal and lingual surfaces of eligible teeth in 42 adult healthy volunteers. Each volunteer underwent 4 identical clinical examinations, being assessed twice by the examiner who performed the first and last exam. RESULTS: Cervical Localisation Code definitions were A: no GR, no coronal TW, B: no GR, distinct coronal TW, C: GR but no coronal TW, D: GR with distinct coronal and root TW. For validation 2073 eligible tooth surfaces were scored. There were only 57 within and 201 between examiner disagreements, the most common being between scores C and D. CONCLUSIONS: The Cervical Localisation Code was used reproducibly by three independent examiners. It will provide focussed data on the cervical region in research studies allowing the association of patient reported dietary and lifestyle factors with specific lesion types, and a tool to aid the management of clinical scenarios, specifically those that lead to dentine hypersensitivity in general dental practice. CLINICAL SIGNIFICANCE: Exposure of dentine at the cervical margin by TW and/or GR often results in dentine hypersensitivity, however current TW indices do not record TW location or GR presence. The Cervical Localisation Code captures both parameters and suggests likely aetiology for dentine hypersensitivity and guide clinical management of the cervical region.

A randomised controlled trial to determine patient experience of a magnetostrictive stack scaler as compared to a piezoelectric scaler, in supportive periodontal therapy.

OBJECTIVES: To compare the pain/discomfort experienced by patients in supportive periodontal therapy, following treatment with a piezoelectric ultrasonic scaler, designed for use with warmed water irrigation, and a magnetostrictive ultrasonic scaler. METHODS: This was a single-centre, randomised, split mouth study with regard to side, and crossover with regard to treatment order. Patients attending general dental practice for supportive periodontal therapy were randomised to receive treatment from one scaler on the left and the other scaler on the right-hand side of the mouth, the left side of the mouth always being treated first. The piezo scaler (Tigon+®) was used with room temperature irrigation for half of the participants (approx 20 °C) and warmed water irrigation (approx 36 °C) for the other half. The magnetostrictive scaler (Cavitron Select SPS 30K®) was used with room temperature irrigation (approx 20 °C) only. Participants rated their pain/discomfort, noise and vibration by VAS scale. RESULTS: 140 participants completed the study. Mean VAS scores for all measures were significantly better for the piezo scaler used with warm irrigation as compared to the magnetostrictive scaler p < 0.001. When both scalers were used with room temperature irrigant, there were no significant differences in the VAS scores between scalers (pain/discomfort, p = 0.68; noise p = 0.2; vibration p = 0.85). CONCLUSIONS: Participants indicated to statistical significance, less pain/discomfort, noise and vibration when the piezo scaler (Tigon+®) device was used with warmed irrigant, compared to the magnetostrictive scaler (Cavitron Select SPS 30K®). There were no significant differences between the instruments when room temperature irrigant was used. CLINICAL SIGNIFICANCE: Regular scaling in supportive periodontal therapy, is essential for maintenance of susceptible patients, however it can be painful due to dentine hypersensitivity deterring patients from attending. Using a piezo scaler with warm water improves patient quality of life and subsequent oral health. This may have positive effects on patient attendance. ISRCTN REGISTERED: ISRCTN15573995.

A randomised clinical trial to determine the effect of a toothpaste containing enzymes and proteins on gum health over 3 months.

OBJECTIVES: This study tested the efficacy of a toothpaste containing enzymes and proteins reflecting those naturally occurring in saliva which play an important role in maintaining bacterial balance to improve gingival health condition and reduce supra-gingival plaque formation over a period of 13 weeks as compared to a commercial control toothpaste. METHODS: This study was a double-blind, randomised, parallel group, 3 month home use study in healthy volunteers. Non-smokers with a mean modified gingival index (MGI) score of between 2.00-2.75 and at least 20 natural teeth, a minimum of 5 teeth in each quadrant were enrolled in the study. At screening, participants underwent a dental prophylaxis and were issued with a standard fluoride toothpaste and toothbrush to use for 4 weeks. After 4 weeks, participants demonstrating ongoing eligibility were assessed for gingival health and plaque score and randomised to either test or control toothpaste, which they used at home twice daily. After 13 weeks, gingival health and plaque were re-scored. RESULTS: 229 participants completed the study. There were no treatment associated adverse events. Plaque and gingival scores were significantly better in the test group as compared to the control group. Furthermore, in the test group plaque and gingival scores fell, while those in the control group rose over the 13 week period. CONCLUSIONS: The test toothpaste containing enzymes and proteins demonstrated significant plaque and gingival benefit compared to the control toothpaste, and was well tolerated. CLINICAL SIGNIFICANCE: Toothbrushing with the test product derived from naturally occurring enzymes and proteins had a clinical adjunctive improvement on gingival health compared to brushing alone with a commercially available fluoride toothpaste.

Amplification of the HER2 gene in breast cancers testing 2+ weak positive by HercepTest immunohistochemistry: false-positive or false-negative immunohistochemistry?

BACKGROUND: The majority of cases of breast cancer scoring HER2 weak positive (2+) on immunohistochemistry (IHC) using the HercepTest are not associated with amplification of the HER2/neu gene. AIM: To examine the reproducibility of IHC in cases scoring 2+ subsequently shown to have gene amplification by fluorescence in-situ hybridisation (FISH). METHODS: A retrospective analysis of 153 cases referred for FISH confirmation of a weak positive HercepTest (2+) result was performed. Repeat IHC was undertaken in cases with weak positive (2+) referral IHC and amplification of the HER2 gene by FISH. RESULTS: Amplification of the HER2 gene was confirmed in 29/153 cases (19%) scoring 2+ on IHC. Repeat IHC was carried out on 25 IHC 2+ cases: 7 (28%) scored 2+ on repeat IHC, 18 (72%) scored 3+ and were reclassified as strong positive. A heterogeneous expression pattern was present in 3/17 cases scoring 3+. CONCLUSIONS: The majority of HercepTest 2+ results are not accompanied by gene amplification and represent "false positive" IHC in terms of prognostic or therapeutic relevance. A small proportion of HercepTest 2+ scores represent true 2+ IHC positive cases accompanied by gene amplification: a category probably biologically related to 3+ IHC cases. The remainder of cases of HercepTest 2+ accompanied by gene amplification represent a category of referral IHC 2+ weak positive, FISH amplified, repeat IHC 3+ strong positive, best described as "false negative 2+ IHC". This has implications for selection of cases for FISH analysis where weak positive (2+) IHC score is used as a triage for FISH testing, and for testing strategies in referral laboratories undertaking FISH analysis.