Patient-reported outcome measures between digital and conventional splints for bruxism: systematic review

OLIVEIRA, Juliana Ignacio de; KFOURI, Marina; OLIVEIRA, Simone Saldanha Ignacio de; SILVA, Emily Freitas da; MUKAI, Marcio Katsuyoshi; SESMA, Newton; LAGANÁ, Dalva Cruz

doi:10.4322/bds.2026.e4930

person Juliana Ignacio de OLIVEIRA

Conceptualization · Investigation · Writing – Original Draft Preparation · Writing – Review & Editing

schoolUniversidade de São Paulo, Faculdade de Odontologia, Departamento de Prótese. São Paulo, SP, Brasil.

0000-0001-7556-3631

person Marina KFOURI

Conceptualization · Investigation · Writing – Original Draft Preparation · Writing – Review & Editing

schoolUniversidade de São Paulo, Faculdade de Odontologia, Departamento de Prótese. São Paulo, SP, Brasil.

0000-0002-7904-7666

person Simone Saldanha Ignacio de OLIVEIRA

Data Curation · Investigation · Writing – Original Draft Preparation · Writing – Review & Editing

schoolUniversidade Federal Fluminense, Faculdade de Odontologia, Centro de Disfunção Temporomandibular e Dor Orofacial, Departamento de Odontotécnica. Niterói, RJ, Brasil.

0000-0003-3829-094X

person Emily Freitas da SILVA

Methodology · Visualization · Writing – Review & Editing

schoolUniversidade de São Paulo, Faculdade de Odontologia, Departamento de Prótese. São Paulo, SP, Brasil.

0000-0002-0164-1788

person Marcio Katsuyoshi MUKAI

Data Curation · Methodology · Visualization · Writing – Review & Editing

schoolUniversidade de São Paulo, Faculdade de Odontologia, Departamento de Prótese. São Paulo, SP, Brasil.

0000-0003-1608-7051

person Newton SESMA

Supervision · Writing – Review & Editing

schoolUniversidade de São Paulo, Faculdade de Odontologia, Departamento de Prótese. São Paulo, SP, Brasil.

0000-0001-5044-1742

person Dalva Cruz LAGANÁ

Project Administration · Writing – Review & Editing

schoolUniversidade de São Paulo, Faculdade de Odontologia, Departamento de Prótese. São Paulo, SP, Brasil.

0000-0002-6403-6876

Conflict of Interest

The authors declare no competing interests.

personJuliana Ignacio de Oliveira (Corresponding address)Universidade de São Paulo, Faculdade de Odontologia, Departamento de Prótese, São Paulo, SP, Brazil. Email:
ju_oliveira@alumni.usp.br

Editor:

Sergio Eduardo de Paiva Gonçalves.

Database	Keywords
MEDLINE via PubMed	(ALL ((occlusal AND splint) OR (occlusal AND appliance) OR (hard AND occlusal AND stabilization AND splint) OR (bite AND splint) OR (dental AND splint) OR (stabilization AND splint) OR (dental AND device) OR (bite AND plate))) AND (ALL ((cad/cam) OR (computer AND aided AND design) OR (computer-aided AND manufacturing) OR (3d AND printing) OR (three-dimensional AND printing) OR (additive AND manufacturing) OR (digital AND impression) OR (digital AND articular) OR (intraoral AND scanner) OR (digital AND scanner) OR (digital AND technology) OR (digital AND treatment AND planning) OR (virtual AND planning) OR (software AND dentistry) OR (digital AND workflow) OR (rapid AND prototyping) OR (mill))) AND (ALL ((temporomandibular AND joint AND disorder) OR (tmj AND disorder) OR (temporomandibular AND dysfunction) OR (sleep AND bruxism) OR (bruxism) OR (jaw AND pain) OR (jaw AND disease) OR (orofacial AND pain) OR (myofascial AND pain) OR (parafunction) OR (muscle AND activity)))
Scopus	(ALL ((occlusal AND splint) OR (occlusal AND appliance) OR (bite AND splint) OR (dental AND splint) OR (dental AND guard) OR (dental AND device))) AND (ALL ((cad/cam) OR (computer AND aided AND design) OR (computer-aided AND manufacturing) OR (3d AND printing) OR (additive AND manufacturing) OR (digital AND fabrication) OR (digital AND impression) OR (intraoral AND scanner) OR (digital AND technology) OR (virtual AND planning) OR (digital AND workflow) OR (rapid AND prototyping))) AND (ALL ((temporomandibular AND joint AND disorder) OR (tmj AND disorder) OR (temporomandibular AND dysfunction) OR (bruxism) OR (sleep AND bruxism) OR (jaw AND disease*)))
Embase	('occlusal splint'/exp OR 'dental splint'/exp OR (dental AND guard) OR 'dental device'/exp) AND ('computer aided design/computer aided manufacturing'/exp OR 'computer aided design'/exp OR 'computer aided manufacturing'/exp OR 'three dimensional printing'/exp OR (digital AND fabrication) OR (digital AND impression) OR 'intraoral scanner'/exp OR 'digital technology'/exp OR (virtual AND planning) OR (digital AND workflow) OR 'rapid prototyping'/exp OR milled OR milling) AND ('temporomandibular joint disorder'/exp OR (tmj AND disorder*) OR 'bruxism'/exp OR 'sleep bruxism'/exp OR 'jaw disease’/exp)
Web of Science	(occlusal splint* (All Fields) or occlusal appliance* (All Fields) or bite splint* (All Fields) or dental splint* (All Fields) or dental guard (All Fields) or dental device* (All Fields)) AND (cad cam (All Fields) or computer aided design (All Fields) or computer-aided manufacturing (All Fields) or 3d printing (All Fields) or additive manufacturing (All Fields) or digital fabrication (All Fields) or digital impression* (All Fields) or intraoral scanner* (All Fields) or digital technology (All Fields) or virtual planning (All Fields) or digital workflow* (All Fields) or rapid prototyping (All Fields)) AND (temporomandibular joint disorder* (All Fields) or tmj disorder* (All Fields) or temporomandibular dysfunction (All Fields) or bruxism (All Fields) or sleep bruxism (All Fields) or jaw disease* (All Fields))
Cochrane	(occlusal splint* OR occlusal appliance* OR bite splint* OR mouth guard* OR dental splint* OR night guard* OR bite guard* OR dental guard OR mandibular advancement device* OR mandibular repositioning device* OR dental device* OR orthodontic device* OR dental prosthesis* OR dental orthotics) and (CAD-CAM OR computer aided design OR computer-aided manufacturing OR 3D printing OR digital dentistry OR digital fabrication OR additive manufacturing OR digital impression OR intraoral scanner OR digital model OR digital technology OR digital treatment planning OR virtual planning OR software dentistry OR digital workflow OR prototype OR rapid prototyping) and (bruxism OR “temporomandibular joint disorder” OR “temporomandibular joint” OR TMJ disorder OR TMJ syndrome OR jaw pain OR jaw disease)
BVS	((“Tecnologia Digital em Odontologia” OR “Impressão Tridimensional” OR “CAD/CAM”)) AND (“Disfunção Temporomandibular” OR “Tratamento de Disfunção Temporomandibular” OR “mialgia”) AND (“Dispositivos Oclusais” OR “placas oclusais” OR “placa oclusal”)

Author	Study design	Number of patients (mean age)	Inter-occlusal record	Digital splint material and minimum thickness	Conventional splint material and minimum thickness	Follow up period	Bruxism assessment criteria	Exclusion criteria
Wang et al. [³²]	Randomized Clinical Trial	16 (18-44 years)	Leaf gauge	Milled	Hard transparent acrylic - 2mm	3 months	Clinically diagnosed probable sleep bruxism (SB) Lobbezoo et al. [²]	Prior orthodontic or prosthodontic treatment, sleep-related conditions impairments, medical disorders, severe malocclusion, or occlusal affecting malformation were excluded
Wang et al. [³²]	Randomized Clinical Trial	16 (18-44 years)	Leaf gauge	Polyether ether ketone (PEEK) - 0.5mm	Hard transparent acrylic - 2mm	3 months
Bargellini et al. [¹⁵]	Randomized Clinical Trial	26 (25.8 ± 2.6 years)	NR	3D-printed - 2mm	1.25mm thermoformed	3 months	An instrumental diagnosis of SB with at least 2 or more episodes per hour of sleep - validated SB diagnosis conducted using a dedicated electromyography-electrocardiography	Absence of sleep bruxism, lack of full autonomous behavioral and expressive capacity. History of bruxism, orthodontic, and dental restoration treatments. Severe dental deformities, factors affecting occlusion, and sleep-related conditions
					polyethylenterephthalat–glycol copolyester (PET-G)		(EMG–ECG) holter (Bruxoff®, OT Bioelettronica, Torino, Italy)
					rebased with autopolymerizing resin
					- 2mm
Brandt et al. [³³]	Crossover Clinical Study	30	None (maximum intercuspal position)	Milled poly methyl methacrylate (PMMA)	Prosthetic resin - 1mm	3 months	Presence of parafunctional activity:	Psychosomatic disorders, substance addiction, pregnancy, malignancy, recent trauma or inflammation, bisphosphonate therapy within 5 years, use of removable dental prostheses, material hypersensitivity, and extensive temporomandibular disorders (TMDs)
Brandt et al. [³³]	Crossover Clinical Study	30	None (maximum intercuspal position)	- 1mm	Prosthetic resin - 1mm	3 months	no information about a specific questionnaire
Wang et al. [²⁸]	Randomized Clinical Trial	30	NR	Milled PEEK - 1mm	Soft splints using a vacuum-forming machine - 2mm	Baseline	Clinically diagnosed probable SB Lobbezoo et al. [²]	Absence of bruxism; lack of full autonomy to communicate and express oneself; previous orthodontic treatment and occlusal adjustment performed to manage bruxism; severe malocclusion or other factors that may affect occlusion; sleep-related disorders
Wang et al. [²⁸]	Randomized Clinical Trial	30	NR	Milled PEEK - 1mm	Soft splints using a vacuum-forming machine - 2mm	Baseline	Clinically diagnosed probable SB Lobbezoo et al. [²]

Author	Primary outcome (type and measurement)	Results	Secondary outcome (type and measurement)	Results
Wang et al. [³²]	Retention: Visual Analogue Scale (VAS)	No significant differences between devices	Manual time spent (impression	Test < Control
	Retention: Visual Analogue Scale (VAS)	No significant differences between devices	obtaining, splint production and clinical occlusal adjustment using a stopwatch)
	Wearing comfort: VAS	Test > Control
Bargellini et al. [¹⁵]	Quality of life [modified version of the Oral Health Impact Profile (OHIP-14)]	Significant results in the test group; improvement in their lifestyle in 64% of cases and referred to a perceived reduction of their parafunction in 63% of cases	General tonic contractions with splints	There was a significant difference between the groups using oral appliances for general tonic contraction (P = .0009) and a significant difference between times were observed for general tonic contractions (P = .00001). Conventional were better at reducing tonic contractions
			General phasic contraction with splints	Significant differences between recording times were observed for general phasic contractions (P = .002) but not between groups
			General phasic contractions and general tonic contractions without splints	Differences were observed for general phasic contractions (P = .0001) and general tonic contractions (P = .000009) during night recordings without splints
			surface masseter muscle activity (sMMA) with splints	No statistically significant differences were observed between the groups
Bargellini et al. [¹⁵]			sMMA without splints	Significant differences between recording times were observed for the total amount of sMMA (P = 0.01) during night recordings without the use of splints
Bargellini et al. [¹⁵]			Overall sleep bruxism (SB) index	No difference was observed with both splints
Brandt et al. [³³]	Wearing comfort: VAS	No significant differences between devices	Retention (% of antagonistic contacts + VAS)	No significant differences between devices
	Impression technique: VAS	Intraoral scanning was preferred to conventional impressions	Initial stability (% of antagonistic contacts + VAS)	No significant differences between devices
	Habituation time: VAS	No significant differences between devices	Final stability (% of antagonistic contacts + VAS)	No significant differences between devices
	Encroachment on mouth and tongue: VAS	No significant differences between devices	Time required for adjustment (stopwatch)	No significant differences between devices
	Size and volume: VAS	No significant differences between devices
	Stability of fit: VAS	No significant differences between devices
	Ease of handling: VAS	The D (digital) splint was rated significantly better for ease of handling during insertion and removal
	Initial occlusion: VAS	No significant differences between devices
Brandt et al. [³³]	Stability of retention: VAS	No significant differences between devices
Brandt et al. [³³]	Final decision (yes/no in favor of device C or device D)	No significant differences between devices
Wang et al. [²⁸]	Retention (3 points scale)	No statistical difference was observed with both splints	Occlusal contacts (T-scan)	Only the second molar on both sides of the traditional occlusal splint had occlusal contact in the intercuspal position, while the digital occlusal splint had stable and bilaterally balanced contact between the maxillary and mandibular teeth. The occlusal force was uniformly distributed in the test group
	Appearance (3 points scale)	The test group presented higher scores with significant differences between devices
	Occlusal comfort (3 points scale)	Test group presented higher scores with significant differences between devices

Certainty Assessment							Patients in each Workflow
N. of studies/Outcome	Study Design	Risk of Bias	Inconsistency	Indirectness	Imprecision	Other considerations	Digital	Conventional	Effect	Certainty
Comfort
3	RCT	serious limitationsa	serious limitationsb^,c	very serious indirectnessd	no serious limitationse	Wang et al. [³²] and Wang et al. [²⁸]: PEEK splints (minimum thickness varying from 0.5 to 1mm); Brandt et al. [³³]: PMMA splints (minimum thickness of 1mm)	53	53	Wang et al. [³²]: + Brandt et al. [³³]: + Wang et al. [²⁸]: +	⊕⊕ Low
Retention and fit
3	RCT	serious limitations^a	serious limitations^b,c	very serious indirectness^d	serious limitationsf	“	53	53	Wang et al. [³²]: - Brandt et al. [³³]: - Wang et al. [²⁸]: -	⊕ Very Low
Quality of life
1	RCT	no serious limitations	none	none	no serious limitations^e	None	13	13	Bargellini et al. [¹⁵]: +	⊕⊕⊕⊕ High
SB related EMG activity
1	RCT	no serious limitations	none	none	no serious limitations^e	None	13	13	Bargellini et al. [¹⁵]: +	⊕⊕⊕⊕ High
Preference
1	RCT	serious limitations^a	none	none	serious limitations^f	None	30	30	Brandt et al. [³³]: -	⊕⊕ Low
Appearance
1	RCT	serious limitations^a	none	none	no serious limitations^e	None	15	15	Wang et al. [²⁸]: +	⊕⊕⊕ Moderate
SB overall index
1	RCT	no serious limitations	none	none	serious limitations^f	None	13	13	Bargellini et al. [¹⁵]: -	⊕⊕⊕ Moderate

[1] RCT: Randomized Clinical Trial; PEEK: Polyetheretherketone; PMMA: Polymethylmethacrylate; SB: Sleep Bruxism; EMG: Electromyography.

[TFN1] ^a
All studies included presented some type of risk of bias.

[TFN2] ^b
Wide variation in the effect estimates across studies.

[TFN3] ^c
Considerable heterogeneity in splint material and thickness in the intervention and comparison.

[TFN4] ^d
There is no standard assessment for the outcomes analyzed.

[TFN5] ^e
The studies showed statistically significant differences between groups.

[TFN6] ^f
The studies did not show statistically significant differences between groups.

[TFN7] ⁺
positive effect.

[9] - no effect.

Patient-reported outcome measures between digital and conventional splints for bruxism: systematic review

Medidas de desfechos relatados pelos pacientes entre placas digitais e convencionais para bruxismo: uma revisão sistemática