Correlation Between Root Resorption and Dentin Sialoprotein Upon Application of Different Orthodontic Forces.
1 other identifier
interventional
27
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
July 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedAugust 23, 2018
August 1, 2018
1.5 years
July 13, 2018
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
OTHERheavy intrusive force is to be applied on a first premolar on one side
medium force 25 gm
OTHERmedium intrusive force is to be applied on a first premolar on one side
light force 10 gm
OTHERlight intrusive force is to be applied on a first premolar on one side
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).
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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