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

The Effect of Two Different Types of Forces on Possible Root Resorption in Relation to Dentin Phosphoprotein Levels: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Root Resorption
• Intervention / Treatment: Other: Continuous force; Other: Intermittent force

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University
  • Please Select A Region, State Or Province.
    • Alexandria, Please Select A Region, State Or Province., Egypt
      • Faculty of Dentistry,Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous force; A buccally directed continuous tipping force of 150 g is applied to the maxillary first premolar on one side	Other: Continuous force; 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.
Experimental: Intermittent force; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dentin Phosphoprotein levels	Evaluate and compare the possible effect of continuous and intermittent orthodontic forces on root resorption using dentin phosphoprotein levels.	2 months

Collaborators and Investigators

• Sponsor: Sherifa Ghaleb
• Investigators: Principal Investigator: sherifa ghaleb, Alexandria University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2020
• Primary Completion (Actual): February 18, 2021
• Study Completion (Actual): April 14, 2021

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Gingival crevicular fluid; Root resorption; Dentin Phosphoprotein; Continuous force; Intermittent force
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Resorption; Root Resorption
• Other Study ID Numbers: Dentin Phosphoprotein

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Age, Gender
• IPD Sharing Time Frame: 6 months after any publication.
• IPD Sharing Access Criteria: It will be accessible to all
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No