CClinicalTrials.gg
Status unknownNCT03644537Updated Aug 23, 2018

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

An interventional study of Orthodontic intrusion in Root Resorption, sponsored by Aya Ahmed Moursi El Faham. Status unknown at 1 site in Egypt. Open to female participants aged 15 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-23.

Sponsored by Aya Ahmed Moursi El Faham · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
15 Years to 18 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Root Resorption

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03

Who can participate

Ages eligible
15 Years to 18 Years
Sexes eligible
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

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).
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
27 participants (estimated)

Study arms

  • Other
    heavy force 100gm

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

    Procedure: Orthodontic intrusion

  • Other
    medium force 25 gm

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

    Procedure: Orthodontic intrusion

  • Other
    light force 10 gm

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

    Procedure: Orthodontic intrusion

Interventions

  • ProcedureOrthodontic 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).

05

What researchers measure

Primary outcomes

  1. DSP (DentinSialoProtein )

    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

06

Study locations

1 of 1 sites recruiting
  • economic treatment center, Orthodontics Department, Cairo University
    Cairo, Egypt
    • Mohamed Amgad Kaddah, Phd in Orthodontics · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT03644537
Lead sponsor
Aya Ahmed Moursi El Faham
Responsible party
Aya Ahmed Moursi El Faham (Principal investigator, Cairo University) — Sponsor-investigator
First posted
Aug 23, 2018
Start date
Oct 7, 2017
Primary completion
Apr 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Aug 23, 2018

Study contacts

Aya A El Faham, Master student
Contact
aya.elfaham@gmail.com
01099922902

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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