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Completed

NCT Number: NCT04366869

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

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

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Key information

Conditions

Bruxism Behavior Habits Stomatognathic Diseases Tooth Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MSA

Giza, 311, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

overdenture

Device

removal of overdenture at night

Occlusal splint

Device

occlusal splint on overdenture

Botox

Drug

Botox injection i masseter in temporalis

Other names: Bolitinum Toxins

Primary outcomes

  1. Patient satisfaction: questionnaire

    Time frame: 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 outcomes

  1. Electromyography

    Time frame: 12 months

    measuring muscle activity for massetter and temporalis muscle at baseline,3,6,9,12 months

Sponsors and collaborators

Lead sponsor

October University for Modern Sciences and Arts

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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