Home » Trials » SLCTR/2018/040


The effect of local Platelet rich Plasma Injection on the Rate of Orthodontically Induced Canine Retraction and Root Resorption in Subjects with Bi-Maxillary Protrusion.

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SLCTR Registration Number

SLCTR/2018/040


Date of Registration

14 Dec 2018

The date of last modification

Dec 14, 2018



Application Summary


Scientific Title of Trial

The effect of local Platelet rich Plasma Injection on the Rate of Orthodontically Induced Canine Retraction and Root Resorption in Subjects with Bi-Maxillary Protrusion.


Public Title of Trial

The effect of local Platelet Rich Plasma Injection on the Rate of Orthodontically Induced Canine Retraction and Root Resorption in Subject with Bi-Maxillary Protrusion.


Disease or Health Condition(s) Studied

malocclusion


Scientific Acronym

NONE


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1221-8829


Any other number(s) assigned to the trial and issuing authority

None


Trial Details


What is the research question being addressed?

What is the effect of Platelet Rich Plasma injection (PRP) in the periodontal ligament (PDL) on,

  1. the duration of orthodontic retraction of upper and lower canine teeth
  2. the quality of bone (measured by bone density) in the concerned area distal to the upper canine
  3. the volumetric root resoprtion for upper canine regarding the PRP and control side using Cone-beam computed tomography (CBCT) before and after six months of acceleration
  4. the values of blood inflammatory markers before bracketing and after acceleration

Type of study

Interventional


Study design

Allocation

Single arm study


Masking

Masking not used


Control

Standard therapy


Assignment

Single


Purpose

Treatment


Phase

Phase 1-2


Intervention(s) planned

Study setting - Dermo-dento center , a specialist dermatological and dental center in sulimani city.

Intervention -
• 5ml of Platelet rich plasma will be obtained through double centrifugation of patients venous blood (60 ml) • Twelve cc of PRP will be injected by means of a microsyringe into the buccal and palatal vestibular mucosa distally through the attached gingiva into oral mucosa to the root of the right canines (upper and lower) of each patient under local anesthesia. All injections will be volumetrically equivalent. Injections will be done only once on day zero of retraction and not repeated again. Before the injection of PRP, local anesthesia (Xylocaine) will be injected at the target sites for the pain control. It is a submucosal injection rather than a sub-periosteal injection. It is just similar to the injection of local anesthesia, and it has no certain injection pattern (twelve injection each one will be one cc). Acetaminophen (500 mg) could be prescribed for the postinjection pain control.


Inclusion criteria

1- Aged between 18 and 26 years. 2- Bimaxillary protrusion 3- Minimum crowding(less than 2mm) or minimum spacing (less than 4 mm). 4- Indication for extraction of upper and lower first premolars. 5- The feasibility of bonding brackets. 6- No previous orthodontic treatment. 7- No systemic diseases. 8- Good oral hygiene. DMFT index (decay, missing, filling), plaque index


Exclusion criteria

1- Patients with severe tooth displacement (e.g. ectopic canine) 2- Those reporting the use of medications throughout the study.



Primary outcome(s)

  1. The overall duration of canine retraction. Canine retraction is defined as, the space between the distal surface (connector) of the canine and medial surface of the 2nd premolars (upper and lower) for both the right and left sides before starting retraction(T0) and after 14 days (T1), 30 days (T2)and 60 days(T3) with the use of inLab CAM 15.0 software after scanning the casts with CEREC Omnicam scanner

    [

    12 months

    ]

Secondary outcome(s)

    1. C-reactive protein (hs-CRP) level.
    2. CBC parameters.
    3. Levels of aspartate aminotransferase (AST)
    4. Alanine aminotransferase (ALT)
    5. Gamma glutamyl transferase (GGT)
    6. Alkaline phosphatase (ALP)
    7. Blood Urea
    8. Creatinine
    9. Serum Sodium (Na)
    10. Serum Potassium (K)
    11. Serum Calcium (Ca)
    12. Serum Total protein (TP)
    13. Albumin (Alb)
    14. Bone Density Area. The area distal to maxillary left and right canines will be selected as the target area. Before measuring the bone densities around the teeth, the whole CBCT images will be resliced to obtain new slices that will perpendicular to the longitudinal axes of the teeth by using the “reslice” function. The bone density distal to the canines will be assessed at intermediate level (between the cervical and apical levels). Hounsfield units (HU) of bone tissue will be used in assessing radiographic bone density under identical dental CBCT scan settings; this method can be used to analyze changes in bone density around a tooth position before and after orthodontic treatment (Pauwels et al, 2017).
    15. Root resorption will be evaluated by volumetric measurement (Baysal et al, 2012). Volume renderings will be reconstructed, and the volumetric images will be manipulated to display the root surfaces from various orientations. On these 3D images, the canines will be conservatively segmented. After segmentation, teeth will be separated from the other teeth and adjusted for 3D orientations. Incisor edge oriented parallel to the floor. Root will be isolated and color coded. The volume of each root will be calculated using the Mimic software program. The root volume loss will be calculated as the difference between the pre-treatment and post-retraction root volumes.
    [

    12 months

    ]

Target number/sample size

12 female


Countries of recruitment

Iraq


Anticipated start date

2018-12-20


Anticipated end date

2018-10-06


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

University of Sulaimani



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Trefa Mohammed Ali
Sulaimani / iraq
University of sulaimani / Iraq

Mob: 7701529377

trefa.ali@univsul.edu.iq

Contact Person for Public Queries

Trefa Mohammed Ali
Sulaimani / iraq
University of sulaimani / Iraq

Mob: 7701529377

trefa.ali@univsul.edu.iq


Primary study sponsor/organization

trefa Mohammad Ali
sulaimani
university of sulaimani / Iraq
Mob: 7701529377

trtrefa.ali@univsul.edu.iq

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results