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. 2024 Jun 20;84(7):779–809. doi: 10.1007/s40265-024-02048-x

Table 4.

Original randomized controlled studies from the systematic reviews included in this umbrella review

Original BoNT-A study
Disorder		 Type Number of subjects Age BTX type, dose (dose/side) Injection
p/muscle		 Control Outcome Included in studies (n) Included in studies (authors)

Al-Wayli, 2017

Saudi Arabia

Probable sleep bruxism

RCT

Parallel

50

50 F, 0 M

20–60 y

Mean 45.5 y

Botox®

40 U

(20 U MM)

Single session

3 points MM

 Conventional method (splint)

Pain (VAS)

AE

 6 Chen, 2023; Cheng, 2020; Fernández-Núnez, 2019; Machado, 2020; Nowak, 2021; Rajamoorthy, 2023.

Alwayli, 2021

Saudi Arabia

Probable sleep bruxism

TMD pain in MM or TM due to bruxism

RCT

Parallel, double-blind

40

24 F, 16 M

 21–52 y

Botox®

40 U

(20 U MM)

Single session

3 points MM

 Saline solution Pain (VAS) 1 Chen, 2023

De Carli, 2016

Brazil

MFP (TMD)

RCT

Parallel, single-blind

15

13 F, 2 M

 Mean: 38 y

Botox®

270 U

(60 U MM, 30 U TM) + (30 U MM, 15 U TM)

 Two sessions, 30 U, and 15 U after 15 d LLLT

Pain (VAS)

MMO (mm)

 6 Almutairi, 2020; Delcanho, 2022; Machado, 2018; Machado, 2020; Patel, 2019; Ramos-Herrada, 2022.

De La Torre Canales, 2020

MFP (RDC/TMD)

RCT

Parallel, double-blind

100

100 F, 0 M

 Mean: 36.8 y

Botox®

80 U

(30 U MM, 10 U TM)

140 U

(50 U MM, 20 U TM)

200 U

(75 U MM, 25 U TM)

Single session

5 points MM, and 5 points TM

Saline solution

Splint

Pain (VAS)

MMO (mm)

AE

 5 Delcanho, 2022; Di Francesco, 2022; Moussa, 2023; Owen, 2022; Ramos-Herrada, 2022.

De la Torre Canales, 2021

MFP (RDC/TMD)

RCT

Parallel

 54 (54 F, 0 M)

18–45 y

Mean: 31.9 y

Botox®

80 U

(30 U MM, 10 U TM)

Single session

5 points MM, and 5 points TM

Saline solution

Acupuncture

Pain (Vas)

AE (EMG)

 1 Di Francesco, 2022.

Ernberg, 2011

Sweden/Denmark

MFP (RDC/TMD)

RCT

Cross-over, double-bind

21

19F, 2 M

> 18 y

Mean: 38 y

Botox®

100 U

(50 U MA)

Single session

3 points MM

 Saline solution

Pain (VAS)

MMO (mm)

AE

 19 Al-Moraissi, 2020; Al-Moraissi, 2021; Almutairi, 2020; Awan, 2019; Chen, 2015; Dall, 2013; De la Torre Canales, 2019; Delcanho, 2022; Di Francesco, 2022; Feng, 2019; Khalife, 2016; Machado, 2012; Machado, 2018; Machado, 2020; Nowak, 2021; Patel, 2019; Ramos-Herrada, 2022; Sposito, 2014; Thambar, 2020.

Guarda-Nardini, 2008

Italy

MFP (RDC/TMD) and bruxism

RCT

Parallel, double-blind

20

10F, 10M

 25–45 y

Botox®

100 U

(30 U MA, 20 U TA)

 Single session, 4 points MM, 3 points TM Saline solution

Pain (VAS)

MMO (mm)

AE (Masticatory efficiency)

 21 Ahmed, 2019; Al-Moraissi, 2020; Al-Moraissi, 2021; Awan, 2019; Chen, 2015; Chen, 2023,; Dall, 2013; De la Torre Canales, 2019; Di Francesco, 2022; Fernández-Núnez, 2019; Ihde, 2007; Khalife, 2016; Linde, 2011; Machado, 2012; Machado, 2018; Machado, 2020; Patel, 2019; Rajamoorthy, 2023; Sposito, 2014; Thambar, 2020; Zhang, 2011.

Guarda-Nardini, 2012

Italy

MFP (RDC/TMD)

RCT

Parallel, double-blind

30

22F, 8 M

23–69 y

Mean: 47.7 y (BTX), 43.2 y (CTR)

Dysport®

300 U

 Single session, >5 points MM Fascial manipulation

Pain (VAS)

MMO

AE

 16 Ahmed, 2019; Al-Moraissi, 2020; Al-Moraissi, 2021; Awan, 2019; Chen, 2015; Dall, 2013; De la Torre Canales, 2019; Delcanho, 2022; Di Francesco, 2022; Feng, 2019; Machado, 2018; Machado, 2020; Nowak, 2021; Patel, 2019; Ramos-Herrada, 2022; Thambar, 2020.

Gupta, 2016

MFP (TMD)

RCT

Parallel

 24 20–50 y

Botox®

100 U

(30 U MM, 20 U TM)

Single session

3 points MM, 2 points TM

 Saline solution

Self-reported Pain

AE (incl. EMG)

 1 Ramos-Herrada, 2022.

Jadhao, 2017

India

Self-reported bruxism and MFP

RCT

Parallel

 24 20–35 y

Botox®

100 U each side

(30 U MM, 20 U TM)

Single session

4 points MM, 3points TM

Saline solution

No treatment

Pain

AE (MBF)

 7 Al-Moraissi, 2020; Al-Moraissi, 2021; Chen, 2023; Cheng, 2020; Delcanho, 2022; Machado, 2020; Rajamoorthy, 2023.

Kaya, 2021

Turkey

MFP in MM due to bruxism

RCT

Parallel

40

33 F, 7 M

18–45 y

Mean: 26.3 y

Botox®

48 U

(24 U MM)

 Single session Conventional method (splint)

Pain (VAS)

AE (MBF)

 3 Chen, 2023; Di Francesco, 2022; Rajamoorthy, 2023.

Kurtoglu, 2008

Turkey

MFP (RDC/TMD)

RCT

Parallel, double-blind

24

22 F, 2 M

16–53 y

Mean: 29.6 y BTX; 23.4 control

Botox®

100 U

(30 U MM, 20 U TM)

Single session

3 points MM, 2 points TM

 Saline solution AE 13 Almutairi, 2020; Awan, 2019; Chen, 2015; De la Torre Canales, 2019; Delcanho, 2022; Khalife, 2016; Machado, 2012; Machado, 2018; Machado, 2020; Patel, 2019; Ramos-Herrada, 2022; Thambar, 2020; Zhang, 2011.

Kütük, 2019

MFP

RCT

Parallel, single-blind

40

29 F, 11 M

 20–60 y

Dysport®

25-150 U

(MM, TM, LPT)

 Single session Dry needling

Pain (VAS)

MMO (mm)

 3 Delcanho, 2022; Griswold, 2023; Ramos-Herrada, 2022.

Lee, 2010

Self-reported Bruxism

RCT

Parallel

12

5F, 7M

20–30 y

Mean: 24.9 y

Dysport®

80 U

(40 U MM)

Single session

3 points MM

 Saline solution AE (EMG) 2 Fernández-Núnez, 2019; Patel, 2019.

Montes Carmona, 2020

TMD myalgia (DC/TMD)

RCT

Parallel, single-blind

60

49 F, 11 M

18–75 y

Mean: 43.6 y

Botox®

100-150 U

(24-30 U MM, 24 U TM, 8 U MPT, 8 U LPT)

Single session

3 points MM, 3 points TM, 1 point MPT, 1 point LPT

Saline solution

LA

Pain (VAS)

MMO (mm)

AE

 2 Di Francesco, 2022; Ramos-Herrada, 2022.

Nixdorf, 2002

USA

MFP (RDC/TMD)

RCT

Cross-over, double-blind

15

15F, 0 M

18–45 y

Mean: 33 y

Botox®

150 U

(50 U MM, 25 U TM)

Single session

3 points MM, 3 points TM

 Saline solution

Pain

MMO

AE

 16 Al-Moraissi, 2020; Al-Moraissi, 2021; Almutairi, 2020; Awan, 2019; Chen, 2015; Dall, 2013; De la Torre Canales, 2019; Delcanho, 2022; Khalife, 2016; Linde, 2011; Machado, 2018; Machado, 2020; Patel, 2019; Sposito, 2014; Thambar, 2020; Zhang, 2011.

Ondo, 2018

USA

Sleep bruxism (polysomnography)

RCT

Parallel, double-blind

23

19 F, 4 M

18–85 y

Mean: 47.4 y

Botox®

200 U

(60 U MM, 40 U TM)

Single session

2 points MM, 3 points TM

 Saline solution

Pain (VAS)

AE

 5 Al-Moraissi, 2020; Al-Moraissi, 2021; Cheng, 2020; Machado, 2020; Rajamoorthy, 2023.

Patel, 2017

USA

TMD symptoms/signs

RCT

Cross-over, double-blind

 20 Not reported

Botox®

170 U

(50 U MM, 25 U TM, 10 U MPT)

 Single session Patients in saline group crossed over to BoNT-A Saline solution

Pain (NRS)

AE

 5 Almutairi, 2020; Machado, 2020; Nowak, 2021; Patel, 2019; Thambar, 2020.

Venâncio, 2008

Brazil

HA with TrP MM, TM or neck

RCT

Parallel, single-blind

45

40 F, 5 M

 18–65 y

Botox®

25-150 U

(25 or 50 U/TrP (1-3)

 Single session

Dry needling

LA

 6 Al-Moraissi, 2020; Al-Moraissi, 2021; Awan, 2019; Dall, 2013; Griswold, 2023; Machado, 2018.

Von Lindern, 2003

Germany

Muscle TMD due to hyperactivity

RCT

Parallel, single blind

 90 Not reported

Botox®

Not clear

if were 35 U total or per muscle

Single session for 71, 2 sessions for 19

(MM, TM, PTM)

 Saline solution

Pain (VAS)

AE

 12 Awan, 2019; Chen, 2015; Dall, 2013; Delcanho, 2022; Di Francesco, 2022; Linde, 2011; Machado, 2012; Machado, 2018; Machado, 2020; Patel, 2019; Sposito, 2014; Thambar, 2020.

Yurittutan, 2019

Turkey

MFP (RDC/TMD)

RCT

Parallel, single-blind

73

45 F, 28 N

> 18 y

Mean 30.6 y

Botox®

90 U

(30 U MM, 15 U TM)

Single session

5 points MM, 3 points TM

Splint

Botulinum toxin + splint

 Pain (VAS) 2 Chen, 2023; Nowak, 2021.

Zhang, 2016

TMD and bruxism

RCT

Parallel

30

6 F, 24 M

 25–37 y

Botox®

100 U

(50 U MM)

Single session

3 points MM

Saline solution

No treatment

 AE (Occlusal force) 4 Chen, 2023; Di Francesco, 2022; Machado, 2020; Patel, 2019.

MFP myofascial pain, TMD temporomandibular disotder, RCT randomized controlled study, MM masseter muscle, TM temporalis muscle, MPT medial pterygoid muscle, LPT lateral pterygoideus muscle, LA local anaesthesia, LLLT low-level laser therapy; MMO maximum mouth opening, AE adverse event, EMG electromyography, MBF maximal bite force