Evidence map›Paper›PMID 32991450›Full record

Trial reportMedicine2020

Antiretroviral treatment and its impact on oral health outcomes in 5 to 7 year old Ugandan children: A 6 year follow-up visit from the ANRS 12174 randomized trial.

Nancy Birungi, Lars T Fadnes, Ingunn M S Engebretsen, James K Tumwine, Anne Nordrehaug Åstrøm, for ANRS 12174 AND 12341 study groups

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00640263 (A Randomised Controlled Trial Comparing the Efficacy of Infant Peri-exposure Prophylaxis With Lopinavir/Ritonavir), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 22% 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.

NCT00640263 phase3completednot on this map

A Randomised Controlled Trial Comparing the Efficacy of Infant Peri-exposure Prophylaxis With Lopinavir/Ritonavir (LPV/r) Versus Lamivudine to Prevent HIV-1 Transmission by Breastfeeding

TypeinterventionalSponsorFrench National Agency for Research on AIDS and Viral HepatitisRan2009 to 2014Enrolled1,500ConditionsHIV InfectionsArmslopinavir/ritonavir (LPV/r), Lamivudine (3TC)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. 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 at 3 institutions in 5 countries.

Nancy BirungiDepartment of Clinical Dentistry.
Lars T FadnesCenter for international health, Department of Global Health and Primary Health Care, University of Bergen.
Ingunn M S EngebretsenDepartment of Global Health and Primary Health Care.
James K TumwineDepartment of Pediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University Kampala, Uganda.
Anne Nordrehaug ÅstrømDepartment of Clinical Dentistry.
for ANRS 12174 AND 12341 study groups
Makerere University · UGUniversité Paris Cité · FRPrimary HealthCare · MT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAntiretroviral therapy for HIV in sub-Saharan Africa has transformed the highly infectious virus to a stable chronic condition, with the advent of Highly active antiretroviral therapy (HAART). The longterm effects of HAART on the oral health of children are understudied.

objectiveTo compare the effect of lopinavir-ritonavir and lamivudine on oral health indicators (dental caries, gingivitis, tooth eruption, and oral health related quality of life) in 5 to 7 year old HIV-1 exposed uninfected children from the ANRS 12174 trial.

methodsThis study used data collected in 2017 among children aged 5 to 7 years from the Ugandan site of the ANRS 12174 randomized trial (ClinicalTrials.gov no: NCT00640263) implemented between 2009 and 2012 in Mbale district, Eastern Uganda. The intervention was lopinavir-ritonavir or lamuvudine treatment to prevent vertical HIV-1 transmission. One hundred thirty-seven and 139 children were randomized to receive lopinavir-ritonavir or lamivudine treatment at day 7 postpartum to compare efficacy of prevention of vertical HIV-1 transmission. At follow up, the children underwent oral examination using the World Health Organization methods for field conditions. The oral health related quality of life was assessed using the early childhood oral health impact scale. Negative binomial and logistic regression were used for the analysis of data.

main outcome measuresDental caries, gingivitis, tooth eruption, and oral health related quality of life) in 5 to 7 year old HIV-1 exposed uninfected children.

resultsThe prevalence of dental caries was 48% in the study sample: 49% in the lopinavir-ritonavir arm and 48% in the lamivudine treatment group. The corresponding mean decayed missing filled teeth and standard deviation was 1.7 (2.4) and 2.3 (3.7) The mean number (standard deviation) of erupted permanent teeth was 3.8 (3.7) and 4.6 (3.9) teeth in the lopinavir- and lamivudine group, respectively. The prevalence of reported impacts on oral health was 7% in the lopinavir-ritonavir and 18% in the lamivudine group. Gingivitis had a prevalence of 7% in the lopinavir-ritonavir and 14% lamivudine treatment group. The regression analysis revealed 70% less reported impacts on oral health in lopinavir-ritonavir group than the lamivudine treatment group with an incidence rate ratio of 0.3 (95% confidence interval: 0.1-0.9).

conclusionsHIV exposed uninfected infants in the lopinavir-ritonavir group reported less impacts on oral health than the lamivudine treatment group. Dental caries, gingivitis, and tooth eruption were not significantly affected by the treatment lopinavir-ritonavir or lamivudine. TRIAL REGISTRATION CLINICALTRIALS. GOV IDENTIFIER: NCT00640263.

Indexed as

Anti-HIV AgentsAnti-Retroviral AgentsAntiretroviral Therapy, Highly ActiveCase-Control StudiesChildChild, PreschoolDental CariesDrug Therapy, CombinationFemaleGingivitisHIV-1HIV InfectionsHumansInfectious Disease Transmission, VerticalLamivudineLopinavirAnti-HIV AgentsAnti-Retroviral AgentsLamivudineLopinavirRitonavir

Identifiers

PMID32991450
PMCPMC7523782
OpenAlexW3087958371

What OpenQuestion holds

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LicenceCC BY-NC
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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.