Evidence map›Paper›PMID 36810835›Full record

Trial reportAesthetic plastic surgery2023

A Two-Center, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of and Satisfaction with Different Methods of ART FILLER® UNIVERSAL Injection for Correcting Moderate to Severe Nasolabial Folds in Chinese Individuals.

Ge Feng, Tong Peng, Wei-Jin Hong, You-Liang Zhang, Guo Li, Wei Zheng, Hang Wang, Sheng-Kang Luo

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Aesthetic plastic surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

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. Article
  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

8 authors.

Ge Feng *State Key Laboratory of Oral Diseases, Department of Cosmetic and Plastic Surgery, Oral and Maxillofacial Surgery, National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China.
Tong Peng *Department of Plastic and Reconstructive Surgery Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, 510317, Guangdong Province, China.
Wei-Jin HongDepartment of Plastic and Reconstructive Surgery Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, 510317, Guangdong Province, China.
You-Liang ZhangDepartment of Plastic and Reconstructive Surgery Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, 510317, Guangdong Province, China.
Guo LiState Key Laboratory of Oral Diseases, Department of Cosmetic and Plastic Surgery, Oral and Maxillofacial Surgery, National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China.
Wei ZhengState Key Laboratory of Oral Diseases, Department of Cosmetic and Plastic Surgery, Oral and Maxillofacial Surgery, National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China.
Hang Wang *State Key Laboratory of Oral Diseases, Department of Cosmetic and Plastic Surgery, Oral and Maxillofacial Surgery, National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China. dr_wanghang@scu.edu.cn.
Sheng-Kang Luo *Department of Plastic and Reconstructive Surgery Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, 510317, Guangdong Province, China. luoshk@gd2h.org.cn.ORCID 0000-0002-5123-1656

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHyaluronic acid is the most popular dermal filler in the treatment of nasolabial folds. Injection methods vary among physicians.

methodsA randomized, two-center, double-blind, intraindividual trial was designed to compare a new method of injecting ART FILLER® UNIVERSAL using the retaining ligament with the traditional method (linear threading and bolus injection) in moderate to severe nasolabial folds. Forty patients with moderate to severe nasolabial folds were randomized into groups A and B. Group A received injections via the traditional method on the left side and the ligament method on the right side, while group B received the reverse. Clinical efficacy and patient safety were independently assessed by a blinded evaluator, the injector, using the Wrinkle Severity Rating Scale (WSRS), the Global Aesthetic Improvement Scale (GAIS), and the Medicis Midface Volume Scale (MMVS) at 4 weeks (before and after the touch-up injection), 8 weeks, 12 weeks, and 24 weeks after the baseline injection.

resultsFrom the perspective of the blinded evaluator, the improvements in WSRS scores from baseline did not differ significantly between the ligament method (0.73  ±  0.61) and the traditional method (0.89 ± 0.61) at week 24 (p > 0.05). The mean GAIS score at week 24 was 1.41 ± 0.49 for the traditional method and 1.32 ± 0.47 for the ligament method (p > 0.05).

conclusionsThe efficacy and safety of the ligament method for the management of nasolabial folds are comparable to those of the traditional method in terms of WSRS and GAIS score improvement in the long run. The ligament method is superior to the traditional method in that it improves midface deficits with fewer adverse events. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . CLINICAL

trial registrationThis study was registered with the Chinese Clinical Trial Registry under the registration number ChiCTR2100041702.

Indexed as

Cosmetic TechniquesDermal FillersSkin AgingDouble-Blind MethodEast Asian PeopleHumansHyaluronic AcidNasolabial FoldPatient SatisfactionProspective StudiesTreatment OutcomeDermal FillersHyaluronic AcidHyaluronic acidInjectionMethodNasolabial fold

Identifiers

PMID36810835

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.