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
The date of last modification
Mar 06, 2020
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
What is the research question being addressed?
What is the effect of Platelet Rich Plasma injection (PRP) in the periodontal ligament (PDL) on,
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Treatment
Study 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.
|
[ 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
2019-01-14
Date of study completion
Recruitment status
Complete: follow up continuing
Funding source
University of Sulaimani, Iraq
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-08-06
Approval number
Not available
Details of Ethics Review Committee
Name: | Ethical Committee, College of Medicine |
Institutional Address: | University of Sulaimani, Iraq |
Telephone: | Not available |
Email: | Not available |
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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results