Platelet-rich Fibrin
Conditions
Brief summary
The aim of this study is to investigate the effect of local injection of injectable platelet rich fibrin (i-PRF) on the rate of orthodontic en masse retraction of anterior teeth clinically and to report any associated pain as well.
Detailed description
Trial will be carried on 2 groups, each involve 13 participants with a total of 26 participants. 1. Subject examination to ensure he/she meets the eligibility criteria of the research. 2. Leveling and alignment using fixed orthodontic appliance. 3. Upper first premolars extraction as a part of the orthodontic treatment planning. 4. With the starting of en masse retraction, injection of the (i-prf) obtained from venous sample palatally and distally to the anterior teeth in the intervention group, and sham injection in the control group. The injection in both groups will be done just before retraction, 21 and 42 days after beginning of retraction Rate of en masse retraction will be calculated for patients in both groups at the monthly basis for for months after starting en masse retraction, data will be analyzed statistically.
Interventions
BIOLOGICALinjectable platelet rich fibrin(i-prf)
I-prf is a second-generation PRP where autologous platelets and leukocytes are present in a complex fibrin matrix and can be obtained from blood using low-speed centrifugation without adding anticoagulants.
DRUGSham Injection
Sham injection as a placebo injection
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Data assessment will be blinded as an assessor not participating in the study will be responsible for measuring the rate of en masse retraction, as the patient name could be hidden during data analysis. The models will be coded with numbers assigned to the participants, and will be sent to an assessor not participating in the research.
Intervention model description
interventional group will receive injectable platelet rich fibrin intraligamentally distal to the right and left canines, and palatal to the upper 4 incisors, in three time points with 21 days interval, control group will receive sham injection instead.
Eligibility
Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. Orthodontic patients with and age range (16 - 30) years. 2. Protruded upper anterior teeth requiring extraction of first premolars and anterior teeth retraction; Angle class I mal-occlusion with bi-alveolar dental protrusions or class II division 1. 3. Patients with full permanent dentition (with the exception of third molars). 4. Healthy dental and periodontal condition with good oral hygiene
Exclusion criteria
1. Patients with extensive restorations on the anterior teeth. 2. Subjects taking medication affecting inflammatory process of the orthodontic tissue reaction. 3. History of previous orthodontic treatment or trauma to the anterior teeth. 4. Syndromic patients and patients with systemic diseases. 5. Poor oral hygiene or periodontal diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of En masse retraction | 4 months | Alginate impression will be taken for each participant to obtain a plaster model obtained at five time points: before incisor retraction (T0), after one month (T1), after two months (T2), after three months(T3), and after four months (T4) of retraction. The models will be coded with numbers assigned to the participants, and will be sent to an assessor not participating in the research. In both groups, the amount of space closure will be calculated by a digital caliper in millimeters for each time point (T) and averaged for right and left sides. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Associated Pain | 4 months | Pain will be assessed using a visual analogue scale questionnaire that will be completed by the patient starting from the day following i-prf injection in the intervention group or the sham injection in the control group, the questionnaire will be repeated every month until the fourth month |
Countries
Egypt
Contacts
Primary ContactAhmed Sabrah, Master Degree of Orthodontics
Outcome results
None listed