NCT04366869

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

April 21, 2020

Last Update Submit

December 15, 2020

Conditions

Bruxism

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction: questionnaire

    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.

    12months

Secondary Outcomes (1)

  • Electromyography

    12 months

Study Arms (3)

control

ACTIVE COMPARATOR

traditional approach of removing denture at night

Device: overdenture

intervention 1

EXPERIMENTAL

occlusal splint

Device: occlusal splint

intervention 2

EXPERIMENTAL

Botox

Drug: Botox

Interventions

overdentureDEVICE

removal of overdenture at night

control
occlusal splintDEVICE

occlusal splint on overdenture

intervention 1
BotoxDRUG

Botox injection i masseter in temporalis

Also known as: Bolitinum Toxins
intervention 2

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MSA

Giza, 311, Egypt

Location

MeSH Terms

Conditions

Bruxism

Interventions

Denture, OverlayOcclusal SplintsBotulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Intervention Hierarchy (Ancestors)

DenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentBotulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Dina Elawady, PHD

    Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 29, 2020

Study Start

July 7, 2019

Primary Completion

July 7, 2020

Study Completion

August 1, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

EG(1)