NCT04825665

Brief Summary

External root resorption is a common unfavourable sequel of orthodontic treatment. Although diagnosis of root resorption is usually done by radiographs; they are technique sensitive. Dentine phosphoprotein, a non-collagenous protein, is suggested to be released into the gingival crevicular fluid during active root resorption, serving as a good diagnostic tool. Also, the manner of force application is a modifiable factor suggested to affect root resorption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

March 29, 2021

Last Update Submit

July 19, 2021

Conditions

Root Resorption

Keywords

Root resorptionGingival crevicular fluidDentin PhosphoproteinContinuous forceIntermittent force

Outcome Measures

Primary Outcomes (1)

  • Dentin Phosphoprotein levels

    Evaluate and compare the possible effect of continuous and intermittent orthodontic forces on root resorption using dentin phosphoprotein levels.

    2 months

Study Arms (2)

Continuous force

EXPERIMENTAL

A buccally directed continuous tipping force of 150 g is applied to the maxillary first premolar on one side

Other: Continuous force

Intermittent force

EXPERIMENTAL

A buccally directed tipping force of 150 g removed every 21 days for a 7-day rest period applied to the maxillary first premolar on one side

Other: Intermittent force

Interventions

Continuous forceOTHER

A buccally directed continuous tipping force of 150 g is applied to the maxillary first premolar by a cantilever spring made of 0.017" x 0.025" beta-titanium-molybdenum alloy inserted in the tube of the upper first molar, bypassing the second premolar and attaching to the upper first premolar. The buccal tipping force will be checked and reactivated to the original level on the 28th day of the 8 week study period.

Continuous force
Intermittent forceOTHER

A buccally directed tipping force of 150 g is applied to the maxillary first premolar by a cantilever spring made of 0.017" x 0.025" beta-titanium-molybdenum alloy inserted in the tube of the upper first molar and attaching to the upper first premolar. The buccal tipping force will be removed every 21 days for a 7-day rest period, where a passive wire of the same gauge and material of the cantilever spring (0.017" x 0.025" beta-titanium-molybdenum alloy) will be placed instead to maintain the position of the upper first premolar during the rest period.

Intermittent force

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Malocclusion that requires extraction of first maxillary premolars on both sides.
  • No previous reported or observed dental treatment to the teeth to be extracted.
  • No previous reported or observed trauma to the teeth to be extracted.
  • No previous reported or observed orthodontic treatment involving the teeth to be extracted.
  • Free of any systemic disease affecting the dentition.

You may not qualify if:

  • Past or present signs or symptoms of periodontal disease.
  • Past or present signs or symptoms of bruxism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Dentistry,Alexandria University

Alexandria, Please Select A Region, State Or Province., Egypt

Location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Related Publications (1)

  • Ghaleb S, Tamish N, ElKenany W, Guindi M. The effect of two different types of forces on possible root resorption in relation to dentin phosphoprotein levels: a single-blind, split-mouth, randomized controlled trial. Prog Orthod. 2021 Dec 20;22(1):44. doi: 10.1186/s40510-021-00388-y.

    PMID: 34927213DERIVED

MeSH Terms

Conditions

Root Resorption

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic Diseases

Study Officials

  • sherifa ghaleb

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Instructor, Principal investigator

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

March 17, 2020

Primary Completion

February 18, 2021

Study Completion

April 14, 2021

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Age, Gender

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after any publication.
Access Criteria
It will be accessible to all

Locations

EG(2)