NCT04149366

Brief Summary

vacuum formed retainer act as bite raiser that increase vertical dimension which may affect Tempromandibular joint and aim of this study is to perform clinical and radiographic evaluation of different thickness of vacuum formed retainer (Essix retainer) during retention phase after orthodontic treatment

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

October 27, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

October 29, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2020

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

October 27, 2019

Last Update Submit

October 30, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Clinical effect of retainer on temporomandibular joint

    Absence of pain, deviation and trismus

    9 months

  • Radiographic effect of retainer on tempromandibular joint

    Normal dissc position

    9 months

Study Arms (4)

group 1 (Wrapround retainer)

Device: Retainer

Group 2 (Essix retainer 1mm)

Group 3 (Essix retainer 1.5 mm)

Group 3 (Essix retainer 2mm)

Interventions

RetainerDEVICE

Orthodontic retainer

group 1 (Wrapround retainer)

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

patients that have finished fixed orthodontic treatment with no signs or symptoms of temporomandibular joint disorders

You may qualify if:

  • patients finished fixed orthodontic treatment with no signs or symptoms of temporomandibular joint disorders
  • patients indicated for removable retainer

You may not qualify if:

  • any systemic disease
  • chronic medication uptake
  • bad oral hygiene pathological conditions of temporomandibular joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Orthodontic Retainers

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

October 27, 2019

First Posted

November 4, 2019

Study Start

October 29, 2019

Primary Completion

August 25, 2020

Study Completion

October 25, 2020

Last Updated

November 4, 2019

Record last verified: 2019-10