Clinical trial NCT04825665: 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
Overall status: COMPLETED
Phase: NA
Conditions: Root Resorption
Keywords: Root resorption
Gingival crevicular fluid
Dentin Phosphoprotein
Continuous force
Intermittent force
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 8
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Dentin Phosphoprotein levels
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry,Alexandria University
state: Please Select A Region, State Or Province.
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: sherifa ghaleb
role: PRINCIPAL_INVESTIGATOR
References:
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.