Evidence map›Paper›PMID 32779386›Full record

Trial reportClinical and experimental dental research2020

Over-the-counter bite splints: A randomized controlled trial of compliance and efficacy.

Geoffrey Gerstner, Wei Yao, Krishnapriya Siripurapu, Hadel Aljanabi, Ann Decker, David Ludkin, Rachel Sinacola, Katherine Frimenko, Kathryn Callaghan, Sean Penoyer and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical and experimental dental research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02340663 (Preliminary Phase IV Trial Comparing the SOVA Night Guard With the Clinical Standard Acrylic Orthotic), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 29% 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.

NCT02340663 nacompletednot on this map

Preliminary Phase IV Trial Comparing the SOVA Night Guard With the Clinical Standard Acrylic Orthotic

TypeinterventionalSponsorUniversity of MichiganRan2015 to 2017Enrolled67ConditionsSleep Bruxism, Tooth WearArmsSOVA Bite Splint, Michigan Bite Splint
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Managements of sleep bruxism in adult: A systematic review.The Japanese dental science review · 2022
    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

11 authors at 1 institution in 1 country.

Geoffrey GerstnerDepartment of Biologic and Materials Sciences and Prosthodontics, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.ORCID 0000-0002-0105-0080
Wei YaoUniversity of Michigan School of Dentistry, Ann Arbor, Michigan, USA.
Krishnapriya SiripurapuDepartment of Biologic and Materials Sciences and Prosthodontics, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.
Hadel AljanabiDepartment of Biologic and Materials Sciences and Prosthodontics, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.
Ann DeckerDepartment of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.
David LudkinDepartment of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.
Rachel SinacolaDepartment of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.
Katherine FrimenkoUniversity of Michigan School of Dentistry, Ann Arbor, Michigan, USA.
Kathryn CallaghanDepartment of Biologic and Materials Sciences and Prosthodontics, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.
Sean PenoyerDepartment of Biologic and Materials Sciences and Prosthodontics, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.
Claire TewksburyDepartment of Biologic and Materials Sciences and Prosthodontics, University of Michigan School of Dentistry, Ann Arbor, Michigan, USA.
University of Michigan · US

Funding

GAS6-Mediated Regulation of Oral Tissue RegenerationK99DE029756 · NIDCR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI DECKER, ANN MARIE · 2020 to 2021
$279k
NIDCR NIH HHS K99 DE029756
6 · The paper itself

Abstract

backgroundOcclusal splints are often used to curb the impacts of sleep bruxism (SB) on the dentition, and over-the-counter (OCT) options are becoming increasingly popular. OTC splints are usually fabricated at home by patients, but not routinely evaluated by dental professionals. It is unclear how OCT splints compare with more traditional splints that receive dental oversight.

objectivesThe present randomized controlled study tested how an OTC splint compared with a gold standard bite splint in terms of patient compliance (primary outcome) and efficacy (secondary outcomes).

methodsSixty-seven subjects were randomly assigned to receive either the OTC (SOVA, N = 35) splint or the gold standard "Michigan" bite splint (MI, N = 32), with 61 completing the study (SOVA, N = 30; MI, N = 31). OTC-splint subjects were required to fabricate their splints to clinically acceptable standards. Both groups wore the splints nightly for four months. Compliance was measured via daily diary. Efficacy outcomes evaluated stability, retention, periodontal health, night-time rhythmic masticatory muscle activity (RMMA), and material wear.

resultsOTC-splint subjects had difficulty fabricating splints to clinically acceptable standards. The number of night-time RMMA bursts was significantly greater for the OTC splint group. Compliance and all other efficacy measurements were not significantly different between-groups.

conclusionsThe results support the potential use of OTC splints for curbing the impacts of SB. However, the results strongly suggest that dentists should be actively engaged in overseeing patients' use of self-fabricated appliances. This clinical trial is registered at ClinicalTrials.gov, Identifier number NCT02340663.

Indexed as

AdultFemaleHumansMaleOcclusal SplintsOral HealthPatient CompliancePeriodontal IndexSeverity of Illness IndexSleep BruxismTreatment OutcomeYoung Adultclinical efficacyocclusal splintssleep bruxismtreatment adherence

Identifiers

PMID32779386
PMCPMC7745066
OpenAlexW3048905299

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.