Evidence map›Paper›PMID 24205951›Full record

Trial reportCommunity dentistry and oral epidemiology2014

Visual scoring of non cavitated caries lesions and clinical trial efficiency, testing xylitol in caries-active adults.

John P Brown, Bennett T Amaechi, James D Bader, Gregg H Gilbert, Sonia K Makhija, Juanita Lozano-Pineda, Michael C Leo, Chuhe Chen, William M Vollmer, X-ACT Trial Collaborative Group

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Community dentistry and oral epidemiology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00393055 (Xylitol Adult Caries Trial), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 26% of its field
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.

NCT00393055 phase3completednot on this map

Xylitol Adult Caries Trial (X-ACT)

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2007 to 2011Enrolled709ConditionsDental CariesArmsxylitol, inactive lozenge
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Recent Advances in Dental Hard Tissue Remineralization: A Review of Literature.International journal of clinical pediatric dentistry
    Review
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

10 authors at 5 institutions in 1 country.

John P BrownDental School, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
Bennett T Amaechi
James D Bader
Gregg H Gilbert
Sonia K Makhija
Juanita Lozano-Pineda
Michael C Leo
Chuhe Chen
William M Vollmer
X-ACT Trial Collaborative Group
Kaiser Permanente Center for Health Research · USThe University of Texas Health Science Center at San Antonio · USUniversity of Alabama at Birmingham · USJohn Brown University · USUniversity of North Carolina at Chapel Hill · US

Funding

Xylitol Adult Caries Trial (X-ACT) Data Coordinating CenterU01DE018047 · NIDCR · KAISER FOUNDATION RESEARCH INSTITUTE · PI VOLLMER, WILLIAM MARION · 2006 to 2011
$3.3M
Xylitol Adult Caries Trial (X-ACT): UAB Clinical CenterU01DE018049 · NIDCR · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GILBERT, GREGG H · 2006 to 2010
$1.2M
Xylitol Adult Caries Trial (X-ACT) UTHSC San Antonio Clinical CenterU01DE018050 · NIDCR · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI AMAECHI, BENNETT TOCHUKWU · 2006 to 2010
$1.1M
Xylitol Adult Caries Trial (X-ACT)--UNC Clinical CenterU01DE018048 · NIDCR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI SHUGARS, DANIEL A · 2006 to 2010
$954k
Xylitol Adult Caries Trial (X-ACT)--Study Chair applicationU01DE018038 · NIDCR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BADER, JAMES D · 2006 to 2010
$461k
NIDCR NIH HHS U01 DE018038NIDCR NIH HHS U01DE018038NIDCR NIH HHS U01 DE018047NIDCR NIH HHS U01DE018047NIDCR NIH HHS U01 DE018048NIDCR NIH HHS U01DE018048NIDCR NIH HHS U01 DE018049NIDCR NIH HHS U01DE018049NIDCR NIH HHS U01 DE018050NIDCR NIH HHS U01DE018050
6 · The paper itself

Abstract

objectivesTo better understand the effectiveness of xylitol in caries prevention in adults and to attempt improved clinical trial efficiency.

methodsAs part of the Xylitol for Adult Caries Trial (X-ACT), non cavitated and cavitated caries lesions were assessed in subjects who were experiencing the disease. The trial was a test of the effectiveness of 5 g/day of xylitol, consumed by dissolving in the mouth five 1 g lozenges spaced across each day, compared with a sucralose placebo. For this analysis, seeking trial efficiency, 538 subjects aged 21-80, with complete data for four dental examinations, were selected from the 691 randomized into the 3-year trial, conducted at three sites. Acceptable inter- and intra-examiner reliability before and during the trial was quantified using the kappa statistic.

resultsThe mean annualized noncavitated plus cavitated lesion transition scores in coronal and root surfaces, from sound to carious favoured xylitol over placebo, during the three cumulative periods of 12, 24, and 33 months, but these clinically and statistically nonsignificant differences declined in magnitude over time. Restricting the present assessment to those subjects with a higher baseline lifetime caries experience showed possible but inconsistent benefit.

conclusionsThere was no clear and clinically relevant preventive effect of xylitol on caries in adults with adequate fluoride exposure when non cavitated plus cavitated lesions were assessed. This conformed to the X-ACT trial result assessing cavitated lesions. Including non cavitated lesion assessment in this full-scale, placebo-controlled, multisite, randomized, double-blinded clinical trial in adults experiencing dental caries did not achieve added trial efficiency or demonstrate practical benefit of xylitol.

trial registrationClinicalTrials.Gov NCT00393055.

Indexed as

AdultAgedAged, 80 and overDental CariesFemaleHumansMaleMiddle AgedSucroseSweetening AgentsTreatment OutcomeUnited StatesXylitolSucroseSweetening AgentstrichlorosucroseXylitoladultsclinical trial efficiencydental caries preventionearly caries lesionnon cavitated caries lesionrandomized controlled trialxylitol

Identifiers

PMID24205951
PMCPMC4014519
OpenAlexW1994132783

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.