An exploratory clinical trial to evaluate the efficacy of an experimental dentifrice formulation in the relief of dentine hypersensitivity

Parkinson, Charles; Constantin, Paul; Goyal, C Ram; Hall, Claire

doi:10.1016/j.jdent.2016.10.013

Cited by 6 publications

(15 citation statements)

References 10 publications

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“…For example randomization based on stratification according to the participants' age, gender, baseline mean thermal (air blast) and tactile (Yeaple Probe) sensitivity scores in to the treatment groups or a modification of these variables 17,20,21,22,23,25,26,28,40,47. Other studies used a randomisation process involving a lottery method to allocate participants to the various groups [33], or used a computer-generated random table to ensure double blinding during the study [37] as well as using a list of random numbers sequentially from a Sponsor's Biostatistics Unit [38,[43][44][45][49][50][51]. The study by Naoum, et al [46] used a computer algorithm to limit the impact of age, gender, diet, and current level of oral hygiene on the study.…”

Section: Methodsmentioning

confidence: 99%

“…All the included studies meet the guidelines in relation to the study duration ranging from six to 12 weeks (assessment at baseline, mid-point, end-point assessment). There were five studies of six weeks duration [24,30,33,36,48], one study of 10 weeks duration [46] two studies over 12 weeks duration [27,43] and 27 of studies of eight weeks duration [17][18][19][20][21][22][23][25][26]28,29,31,32,34,35,[37][38][39][40][41][42]44,45,47,[49][50][51].…”

Section: Durationmentioning

confidence: 99%

“…Most of the included studies (91%; n=32) included at least 25 subject per arm, three studies [17,32,46], included less than 25 per arm. Only 12 studies provided information on any power calculation (formally or informally), for example to detect statistically significant differences between treatment groups using a two tailed alpha 0.05 and a power of 80% [30][31][32][33]36,39,[44][45]47,[49][50][51]. Studies also included a 5% or 10% 'drop out' calculation to allow for the relevant number of participants completing the respective studies.…”

Section: Sample Size and Statistical Powermentioning

confidence: 99%

“…One way of avoiding this problem is by reporting on the number of withdrawals or dropouts as if they were still a part of the clinical trial; this is called the intention-to-treat analysis (52). The number of 'drop-outs' was reported in most of the included studies although only few studies included ITT analysis [18,31,40,44,47,49,51].…”

Section: Consideration Of Withdrawals and Dropoutsmentioning

confidence: 99%

“…Only eight (22.8%) of the studies included a pre-trial run-in/wash-out period ranging from seven days to six weeks [17,18,27,31,[48][49][50][51]. A further two studies reported on a follow up period following the cessation of the intervention [31,46] with Ghasssemi, et al [31] switching the participants from the Enamel Care group after eight weeks to the control dentifrice for a further eight weeks to determine the degree of persistence of pain reduction.…”

Section: Run In /Wash-out Period and Follow Up Assessmentsmentioning

confidence: 99%

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Clinical Trial Designs for the Testing of OTC Products for Dentine Hypersensitivity-A Systematic Review

2020

J Orthod Craniofac Res

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Aim: The aim of the present study was to review the papers in the published literature and to compare the clinical trial methodology used in these studies to evaluate the products for Dentine Hypersensitivity (DH) based on the previously recommended guidelines of Holland, et al. (1997). Material and Methods: A systematic search was conducted on PubMed and Embase for double blind randomized placebo-controlled clinical studies conducted over ≥6 weeks assessing the efficacy of OTC products for the treatment of DH in otherwise healthy adult subjects with reported and diagnosed DH. Results: A total of 35 studies were included in this review from an initial search of 882 titles. All the included studies complied with the guidelines in terms of study design, duration, subject selection, adequate control(s) and subject instructions. 91% of studies used a sample size of ≥ 25 per arm. Most studies (91%) complied with the minimum required number of teeth to be test ed except in two studies. All the studies used an objective assessment however only two studies (22.8%) included a subjective evaluation to an everyday stimulus when evaluating DH. Only two studies included assessment of the impact of DH treatment on the participants' Quality of Life (QoL). Most studies did not include a recommended specific run in/wash period (10 studies [28.5%]) or a follow up period following the cessation of the study (2 studies [5.7%]). All studies reported the reduction of DH as a percentage reduction from baseline values. None of the studies reported a total relief of pain irrespective of the in-tervention(s) evaluated although there were mean reductions in both test and control groups. Conclusions: All of the included studies reported a significant statistical reduction of pain in both the test and control groups, although none of the studies reported the complete absence of the pain response following any of the interventions at the end of the studies. Overall, most studies complied with the recommendations from the Holland, et al. guidelines however, there is still a need to include both a run in/wash out and follow up periods in future studies. Furthermore, it may be recommended to include a subjective evaluation of the treatment outcome to overall sensitivity from day to day activities as well as the effect on the QoL (person-centered approach) in future studies. None of the included studies reported the complete absence of the pain response following any of the interventions at the end of the studies.

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