An interventional study of Continuous force and Intermittent force in Root Resorption, sponsored by Sherifa Ghaleb. Completed at 2 sites in Egypt. Open to participants aged 13 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-23.
Sponsored by Sherifa Ghaleb · Not applicable, Interventional, and Prevention
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.
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.
43 studies on the registry are indexed under Root Resorption; 9 are open to participants now.
This study's enrollment of 8 is below the median of 29 across 36 interventional studies indexed under Root Resorption.
Browse Root Resorption studies →This is the only study on the registry with Sherifa Ghaleb as lead sponsor.
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Exclusion Criteria:
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 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 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.
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.
Dentin Phosphoprotein levels
Evaluate and compare the possible effect of continuous and intermittent orthodontic forces on root resorption using dentin phosphoprotein levels.
Time frame: 2 months
Plan to share: Yes — Age, Gender
Supporting information: Study protocol
Time frame: 6 months after any publication.
Access criteria: It will be accessible to all
Ran from Mar 2020 to primary completion in Feb 2021, 11 months.
Of 25 interventional studies with no phase under Root Resorption, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's 11 months is below that.
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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