Evidence map›Paper›PMID 38530474›Full record

Trial reportClinical oral investigations2024

Efficacy of a stannous fluoride dentifrice for relieving dentinal hypersensitivity in Chinese population: an 8-week randomized clinical trial.

Rui Li, Wenjie Yang, Roberta Grimaldi, Peter Zeng, Gary Smith, Xi Chen

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical oral investigations, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04950465 (An 8 Week, Randomised, Examiner-blind, Controlled Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04950465 nacompletednot on this map

An 8 Week, Randomised, Examiner-blind, Controlled Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population

TypeinterventionalSponsorHALEONRan2021 to 2022Enrolled271ConditionsDentin SensitivityArmsSensodyne Sensitivity & Gum, Crest Cavity Protection Fresh Lime, Sensodyne Repair and Protect
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Rui LiDepartment of Preventive Dentistry, Shanghai Ninth People's Hospital, No. 639 Zhizaoju Road, Shanghai, China.
Wenjie YangDepartment of Preventive Dentistry, Shanghai Ninth People's Hospital, No. 639 Zhizaoju Road, Shanghai, China.
Roberta GrimaldiHaleon (Formerly Known As GSK Consumer Healthcare), Weybridge, UK.
Peter ZengHaleon (Formerly Known As GSK Consumer Healthcare), Shanghai, China.
Gary SmithHaleon (Formerly Known As GSK Consumer Healthcare), Weybridge, UK.
Xi ChenDepartment of Preventive Dentistry, Shanghai Ninth People's Hospital, No. 639 Zhizaoju Road, Shanghai, China. chenx1853@sh9hospital.org.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo compare the effectiveness of using a 0.454% stannous fluoride-containing dentifrice twice daily in relieving dentinal hypersensitivity (DH) in a Chinese population. MATERIALS AND

methodsThis was a single-centre, randomized, controlled, examiner-blind, three-treatment-arm, parallel-group study in participants with clinically diagnosed DH. Subjects who met inclusion criteria (n = 197) were randomly allocated into 3 groups: test group (n = 66)-using a 0.454% stannous fluoride-containing dentifrice twice daily; positive control group (n = 64)-using a 5.0% calcium sodium phosphosilicate-containing dentifrice twice daily; negative control group (n = 67)-using a 1150 ppm of NaF dentifrice twice daily. Status of DH was assessed at week 4 and week 8 by the same independent examiner. Changes from baseline in Schiff sensitivity score, tactile threshold and Dentine Hypersensitivity Experience Questionnaire (DHEQ) score were analysed using analysis of covariance models. The DHEQ evaluated subject-perceived oral health-related quality of life (OHRQoL).

resultsStatistically significant improvements in mean Schiff scores (p < 0.0001 for all products at Weeks 4 and 8), tactile threshold (p < 0.0001 for test and negative control at Weeks 4 and 8: Week 4 p = 0.0040 and Week 8 p < 0.0001 for positive control) and all DHEQ scores (p < 0.01 for all groups) were observed. No statistically significant differences were observed in the adjusted mean between all dentifrices at both timepoints, potentially driven by a placebo effect. Forty-two treatment-emergent adverse events (TEAEs) were reported (n = 32 subjects), with 2 serious AEs (n = 1) in the test group. TEAEs were not considered treatment-related.

conclusionsAll groups demonstrated statistically significant improvements in Schiff score, tactile threshold and OHRQoL. However, due to a possible placebo effect in the negative control, there were no statistically significant differences between the dentifrices. CLINICAL RELEVANCE: This study adds to the growing research exploring why the placebo effect is a common phenomenon in DH studies.

trial registrationClinicalTrials.gov Identifier: NCT04950465.

Indexed as

DentifricesDentin Desensitizing AgentsDentin SensitivityChinaDouble-Blind MethodFluoridesHumansPhosphatesQuality of LifeSodium FluorideTin FluoridesTouchTreatment OutcomeDentifricesDentin Desensitizing AgentsFluoridesPhosphatesSodium FluorideTin FluoridesDentifriceDentinal hypersensitivityPlacebo effectSchiff sensitivity scoreStannous fluorideTactile threshold

Identifiers

PMID38530474
PMCPMC10965716

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.