Correlation Between Root Resorption and Dentin Sialoprotein Upon Application of Different Orthodontic Forces.
Primary Purpose
Root Resorption
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Orthodontic intrusion
Sponsored by
About this trial
This is an interventional prevention trial for Root Resorption
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- economic treatment center, Orthodontics Department, Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
heavy force 100gm
medium force 25 gm
light force 10 gm
Arm Description
heavy intrusive force is to be applied on a first premolar on one side
medium intrusive force is to be applied on a first premolar on one side
light intrusive force is to be applied on a first premolar on one side
Outcomes
Primary Outcome Measures
DSP (DentinSialoProtein )
concentration of DSP is expected to be secreted into the gingival crevicular fluid upon root resorption
Secondary Outcome Measures
Full Information
NCT ID
NCT03644537
First Posted
July 13, 2018
Last Updated
August 21, 2018
Sponsor
Aya Ahmed Moursi El Faham
1. Study Identification
Unique Protocol Identification Number
NCT03644537
Brief Title
Correlation Between Root Resorption and Dentin Sialoprotein Upon Application of Different Orthodontic Forces.
Official Title
Correlation Between Root Resorption and Dentin Sialoprotein Upon Application of Different Orthodontic Forces, a Split-mouth Technique, a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 7, 2017 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aya Ahmed Moursi El Faham
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
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
Detailed Description
Histological and radiographic observations have shown that root resorption is a frequent consequence of orthodontic treatment (Reitan, 1974; Rygh, 1977; Harry and Sims, 1982). In most patients this resorption is minor and of no importance. A few teeth however exhibit severe resorption. In a study by Goldson and Henrikson (1975) it was found that 6 per cent of 924 teeth were resorped more than 2 mm after treatment with a Begg appliance and Malmgren et al. ( 1982) found a similar degree of root resorption in 10 percent of 264 incisors treated with an edgewise appliance and in 5 percent of 176 incisors treated with a Begg appliance(1).
Root resorption resulting from undesirable orthodontic force is an unwanted sequele , that fears all orthodontists including their experts as well(2).
DSP are non-collagenous dentin-specific matrix proteins postulated to be involved in the mineralization of pre-dentin into dentin (3,4) .Dentin undergoes continuous deposition throughout life as a secondary dentin only on the pulpal surface. Therefore, these proteins are not routinely released into the surrounding space as dentin does not undergo the process of remodeling as in bone. It is only in the presence of active external root resorption that these proteins could be freed into the periodontal ligament space(5).
Since periapical -intraoral- radiograph gives a two dimensional information, which detect root resorption after 60- 70% of the mineralized tissue is lost. (6) So, it's not sensitive in detecting early root resorption so in this study the investigators introduce the biological marker DSP to monitor root resorption from its onset by collecting samples from the GCF -gingival crevicular fluid- for its detection.
Calculating the amount of DSP -Dentine Sialo Protein- produced upon root resorption might be an indicative biological marker for root resorption.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Resorption
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
heavy force 100gm
Arm Type
Other
Arm Description
heavy intrusive force is to be applied on a first premolar on one side
Arm Title
medium force 25 gm
Arm Type
Other
Arm Description
medium intrusive force is to be applied on a first premolar on one side
Arm Title
light force 10 gm
Arm Type
Other
Arm Description
light intrusive force is to be applied on a first premolar on one side
Intervention Type
Procedure
Intervention Name(s)
Orthodontic intrusion
Intervention Description
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).
Primary Outcome Measure Information:
Title
DSP (DentinSialoProtein )
Description
concentration of DSP is expected to be secreted into the gingival crevicular fluid upon root resorption
Time Frame
with in 3 monthes from applied intrusion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aya A El Faham, Master student
Phone
01099922902
Email
aya.elfaham@gmail.com
Facility Information:
Facility Name
economic treatment center, Orthodontics Department, Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Amgad Kaddah, Phd in Orthodontics
12. IPD Sharing Statement
Learn more about this trial
Correlation Between Root Resorption and Dentin Sialoprotein Upon Application of Different Orthodontic Forces.
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