Correlation Between Root Resorption and Dentin Sialoprotein Upon Application of Different Orthodontic Forces.

Sponsor
Aya Ahmed Moursi El Faham (Other)
Overall Status
Unknown status
CT.gov ID
NCT03644537
Collaborator
(none)
27
1
3
19.8
1.4

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Orthodontic intrusion
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Correlation Between Root Resorption and Dentin Sialoprotein Upon Application of Different Orthodontic Forces, a Split-mouth Technique, a Randomized Clinical Trial
Actual Study Start Date :
Oct 7, 2017
Anticipated Primary Completion Date :
Apr 1, 2019
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: heavy force 100gm

heavy intrusive force is to be applied on a first premolar on one side

Procedure: Orthodontic intrusion
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).

Other: medium force 25 gm

medium intrusive force is to be applied on a first premolar on one side

Procedure: Orthodontic intrusion
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).

Other: light force 10 gm

light intrusive force is to be applied on a first premolar on one side

Procedure: Orthodontic intrusion
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).

Outcome Measures

Primary Outcome Measures

  1. DSP (DentinSialoProtein ) [with in 3 monthes from applied intrusion]

    concentration of DSP is expected to be secreted into the gingival crevicular fluid upon root resorption

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 18 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 economic treatment center, Orthodontics Department, Cairo University Cairo Egypt

Sponsors and Collaborators

  • Aya Ahmed Moursi El Faham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aya Ahmed Moursi El Faham, Principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT03644537
Other Study ID Numbers:
  • CEBD-CU-2018-07-13
First Posted:
Aug 23, 2018
Last Update Posted:
Aug 23, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2018