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The Effect of Two Different Types of Forces on Possible Root Resorption in Relation to Dentin Phosphoprotein Levels

Primary Purpose

Root Resorption

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Continuous force
Intermittent force
Sponsored by
Sherifa Ghaleb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Root Resorption focused on measuring Root resorption, Gingival crevicular fluid, Dentin Phosphoprotein, Continuous force, Intermittent force

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Faculty of Dentistry,Alexandria University
  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Continuous force

Intermittent force

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 29, 2021
Last Updated
July 19, 2021
Sponsor
Sherifa Ghaleb
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1. Study Identification

Unique Protocol Identification Number
NCT04825665
Brief Title
The Effect of Two Different Types of Forces on Possible Root Resorption in Relation to Dentin Phosphoprotein Levels
Official Title
The Effect of Two Different Types of Forces on Possible Root Resorption in Relation to Dentin Phosphoprotein Levels: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 17, 2020 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
April 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherifa Ghaleb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Early detection of teeth at risk of severe resorption is crucial.At present, using radiographs is common but detecting only resorption after 60-70% of the mineralized tissue is already lost. Moreover, they only provide two-dimensional information, identifying apical change primarily. Also, radiographs cannot indicate if the process of root resorption is still active for monitoring its progress and additional radiation exposure to the patient will be needed. Therefore, a safer, more reliable alternative method to clinically diagnose early stages of root resorption is needed and may include detecting biomarkers in gingival crevicular fluid. Furthermore, the relationship between the manner of orthodontic force application and orthodontically induced root resorption is under study. It has been suggested that pausing orthodontic forces during treatment may reduce the amount of root resorption, likely due to cementum repair during the inactive period. This is important specifically in individuals who are biologically and genetically prone to root resorption. The aim of the study is to compare the extent of root resorption between controlled continuous and intermittent orthodontic forces using levels of dentin phosphoprotein in gingival crevicular fluid.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Resorption
Keywords
Root resorption, Gingival crevicular fluid, Dentin Phosphoprotein, Continuous force, Intermittent force

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous force
Arm Type
Experimental
Arm Description
A buccally directed continuous tipping force of 150 g is applied to the maxillary first premolar on one side
Arm Title
Intermittent force
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Continuous force
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Intermittent force
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dentin Phosphoprotein levels
Description
Evaluate and compare the possible effect of continuous and intermittent orthodontic forces on root resorption using dentin phosphoprotein levels.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Past or present signs or symptoms of periodontal disease. Past or present signs or symptoms of bruxism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sherifa ghaleb
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry,Alexandria University
City
Alexandria
State/Province
Please Select A Region, State Or Province.
Country
Egypt
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Age, Gender
IPD Sharing Time Frame
6 months after any publication.
IPD Sharing Access Criteria
It will be accessible to all
Citations:
PubMed Identifier
34927213
Citation
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.
Results Reference
derived

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The Effect of Two Different Types of Forces on Possible Root Resorption in Relation to Dentin Phosphoprotein Levels

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