Evidence map›Paper›PMID 31664632›Full record

Trial reportOdontology2020

Clinical efficacy of an Aloe Vera gel versus a 0.12% chlorhexidine gel in preventing traumatic ulcers in patients with fixed orthodontic appliances: a double-blind randomized clinical trial.

Cristina Leiva-Cala, Alejandro Ismael Lorenzo-Pouso, Belén Centenera-Centenera, Juan López-Palafox, Pilar Gándara-Vila, Abel García-García, Mario Pérez-Sayáns

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Odontology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05147376 (Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances), which is not on this map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
2.2field-weighted citation impact, top 13% 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.

NCT05147376 early_phase1completednot on this mapstarted 2022, after this paper: background citation

Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances: a Randomized Clinical Trial

TypeinterventionalSponsorChulalongkorn UniversityRan2022 to 2023Enrolled70ConditionsOral Ulcer, Orthodontic Appliances, FixedArmsCurcumin mouthwash, Placebo mouthwash
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Review
  9. Effect of probiotics on pain and ulceration in patients undergoing fixed orthodontic treatment.Journal of dental research, dental clinics, dental prospects · 2024
    Article
  10. Article
  11. Dental Restorations.Bioengineering (Basel, Switzerland) · 2023
    Article
  12. [Study on quantitative analysis of bracket-induced nonlinear response of labio-cheek soft tissue during the orthodontic process].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2023
    Article
  13. Article
  14. 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

7 authors at 2 institutions in 1 country.

Cristina Leiva-CalaClinic of Orthodontics, Faculty of Dentistry, Universidad Alfonso X el Sabio, Madrid, Spain.
Alejandro Ismael Lorenzo-PousoOral Medicine, Oral Surgery and Implantology Unit, Faculty of Medicine and Dentistry, Instituto de Investigación Sanitaria de Santiago (IDIS), Universidade de Santiago de Compostela, Entrerríos s/n, 15782, Santiago de Compostela, Spain.
Belén Centenera-CenteneraClinic of Orthodontics, Faculty of Dentistry, Universidad Alfonso X el Sabio, Madrid, Spain.
Juan López-PalafoxLegal and Forensic Dentistry Unit, Faculty of Dentistry, Universidad Alfonso X el Sabio, Madrid, Spain.
Pilar Gándara-VilaOral Medicine, Oral Surgery and Implantology Unit, Faculty of Medicine and Dentistry, Instituto de Investigación Sanitaria de Santiago (IDIS), Universidade de Santiago de Compostela, Entrerríos s/n, 15782, Santiago de Compostela, Spain.
Abel García-GarcíaOral Medicine, Oral Surgery and Implantology Unit, Faculty of Medicine and Dentistry, Instituto de Investigación Sanitaria de Santiago (IDIS), Universidade de Santiago de Compostela, Entrerríos s/n, 15782, Santiago de Compostela, Spain.
Mario Pérez-SayánsOral Medicine, Oral Surgery and Implantology Unit, Faculty of Medicine and Dentistry, Instituto de Investigación Sanitaria de Santiago (IDIS), Universidade de Santiago de Compostela, Entrerríos s/n, 15782, Santiago de Compostela, Spain. mario.perez@usc.es.ORCID http://orcid.org/0000-0003-2196-9868
Universidade de Santiago de Compostela · ESUniversidad Alfonso X el Sabio · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Traumatic oral ulceration (TOU) is one of the most common side effects of orthodontic treatments. The objective of this trial is to compare the clinical efficacy of an 80% Aloe Vera gel, prepared using a master formula, versus a commercial 0.12% Chlorhexidine (CHX) gel for TOU prevention in participants wearing fixed orthodontic appliances. This report represents a single-centre, university-based, double-blinded, randomized controlled trial with 2 parallel arms. Patients aged 12 years or older, in the permanent dentition, and about to start fixed orthodontic treatment in this university setting were randomly allocated to use either Aloe Vera or CHX gel, following the cementation procedure. Pre-treatment and 1 month after the cementation clinical assessment and digital photographic images were taken of the teeth and assessed by 2 clinical assessors for the presence or absence of TOUs. A total of 140 were randomized and completed the trial. The overall prevalence of TOUs was 43.6%. Overall 5.7% of patients treated with Aloe Vera gel showed did not suffer from TOUs, whereas in the CHX arm, a total of 57 (81.4%) were affected by this outcome reaching a significant result (p < 0.001). In terms of relative risk (RRs) and confidence intervals (CIs), Aloe Vera provided better results than CHX with an RR of 0.07 (95%CI 0.03-0.16; p < 0.001), and with a patients' number needed to treat of 1.3 (95%CI 1.16-1.54). There were no adverse effects. These results suggest that Aloe Vera gel administration in patients with fixed orthodontic appliances could be important for effective prevention of TOU.

Indexed as

AloeChlorhexidineChildDouble-Blind MethodHumansOrthodontic Appliances, FixedPlant PreparationsTreatment OutcomeUlcerAloe vera gelChlorhexidinePlant PreparationsBracket cementationDouble-blind randomized clinical trialPeriodontal IndexTraumatic ulcersWound healing

Identifiers

PMID31664632
OpenAlexW2982312471

What OpenQuestion holds

Textmetadata
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.