Which is More Effective in Management of Bruxism: Botox or Occlusal Splints

Which is More Effective in Management of Bruxism for Implant Overdenture Patients: Botox or Occlusal Splints - A One Year Clinical Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04366869

Enrollment

Registered

2020-04-29

Start date

2019-07-07

Completion date

2020-08-01

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism

Brief summary

The aim of this study is to compare the efficacy of Botulinum toxin (Botox) and traditional occlusal splints for the management of bruxism in edentulous patients rehabilitated with MIOD

Detailed description

42 edentulous patients having implant retained mandibular overdenture suffering from bruxism with clinical manifestation, will be randomly divided into three groups, group 1 control group (traditional approach of removing denture at night) ,group 2 will be managed by occlusal splints whereas group 3 will be managed with botulinum toxin injection (Botox). New maxillary dentures and mandibular over dentures will be constructed for both groups. Muscle activity will be measured at time of denture insertion (T0), 3(T3) 6(T6), 9(T9) and 12(T12) month of treatment. Patients satisfaction will be evaluated at the time of denture insertion (T0), 6(T6), and 12(T12) month of treatment using TMD/ NS numeric scales 10 cm questionnaire which include: headache, face pain, face tension, limitation of mouth opening and complaints during mastication.

Interventions

DRUGBotox

Botox injection i masseter in temporalis

DEVICEoverdenture

removal of overdenture at night

DEVICEocclusal splint

occlusal splint on overdenture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* patients diagnosed with bruxism * patients had mandibular implant retained overdentures within the previous 3 years * cooperative patients * physically and psychologically able patients to tolerate the procedure

Exclusion criteria

* patients taking muscle relaxants * patients without neuromuscular control * poor oral hygiene

Design outcomes

Primary

Measure	Time frame	Description
Patient satisfaction: questionnaire	12months	Patients satisfaction was evaluated using TMD/ NS numeric scales 10 cm questionnaire which included: headache, face pain, face tension, limitation of mouth opening and complaints during mastication with scores from 1 to 10 whereas 1 means least pain and 10 means highest pain.it was assessed at baseline (T0), then after 3months(T3) then after 6months from baseline(T6), then after 9months from baseline(T9) and finally after 12 months from baseline (T12). which means every 3 months.

Secondary

Measure	Time frame	Description
Electromyography	12 months	measuring muscle activity for massetter and temporalis muscle at baseline,3,6,9,12 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026