NCT03644537

Brief Summary

Since root resorption is a frequent consequence of orthodontic treatment, DSP are non-collagenous dentin-specific matrix proteins postulated to be involved in the mineralization of pre-dentin into dentin. Calculating the amount of DSP -Dentine Sialo Protein- produced upon root resorption might be an indicative biological marker for root resorption

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

October 7, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

July 13, 2018

Last Update Submit

August 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • DSP (DentinSialoProtein )

    concentration of DSP is expected to be secreted into the gingival crevicular fluid upon root resorption

    with in 3 monthes from applied intrusion

Study Arms (3)

heavy force 100gm

OTHER

heavy intrusive force is to be applied on a first premolar on one side

Procedure: Orthodontic intrusion

medium force 25 gm

OTHER

medium intrusive force is to be applied on a first premolar on one side

Procedure: Orthodontic intrusion

light force 10 gm

OTHER

light intrusive force is to be applied on a first premolar on one side

Procedure: Orthodontic intrusion

Interventions

27 female patients coming to the Orthodontic department, Cairo University seeking orthodontic treatment, where their age ranges from 15 - 18 years, where their treatment plan include extraction of upper first premolars, and using the split-mouth technique, one side will be control group without application of force where the other side will receive intrusive mechanics for the same patient in the upper arch (one side will not receive any force and the same tooth on the other side of the arch will suffer intrusive mechanics, that's why named SPLIT MOUTH TECHNIQUE - as if the arch is split into two subjects, one control subject (tooth) and the other study subject (tooth) . According to the amount of force of the working side, the total number of patients will be divided into 3 groups. Each of 9 subjects, the first group where a light force will be applied (10 gm), the second group where moderate force will be applied (25gm), the third group where heavy force will be applied(100 gram).

heavy force 100gmlight force 10 gmmedium force 25 gm

Eligibility Criteria

Age15 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescent female patients age ranging from 15- 18 yrs, with the full set of the permanent dentition.
  • No previous orthodontic treatment.
  • Class I crowding or Class II malocclusion whose treatment requires extraction of first maxillary premolars.
  • Adequate oral hygiene.

You may not qualify if:

  • Systematic diseases.
  • Bad Oral hygiene.
  • Missing permanent teeth (except for third molars).
  • Uncontrolled Pathological Conditions that may contra-indicate immediate orthodontic treatment (caries, gingivitis, periodontitis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

economic treatment center, Orthodontics Department, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Root Resorption

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic Diseases

Central Study Contacts

Aya A El Faham, Master student

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 13, 2018

First Posted

August 23, 2018

Study Start

October 7, 2017

Primary Completion

April 1, 2019

Study Completion

June 1, 2019

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations