Clinical trial NCT05335824: The Effect of Autologous Platelet Concentrations on Orthodontic Treatment Time
Official title: Comparison Between The Effect of Platelet Rich Plasma (PRP) and Injectable Platelet Rich Fibrin (I-PRF) on Orthodontic Tooth Movement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Division 1 Malocclusion
Keywords: Platelet-rich plasma
Platelet-rich fibrin
Acceleration
Lead sponsor: Damascus University
Sponsor class: OTHER
Collaborators: name: Hama University
First posted: 2022-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 60 patients needed therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines were divided to randomly three groups:

(1) PRP group: Received PRP injections, (2) I-PRF group: Received I-PRF injections, (3) Control group: conventional treatment with no injections. TPAs were used as an anchor unit. Coil springs were used to distalize the upper canines on 0.019 x 0.025-inch stainless archwires. Alginate impressions and dental casts of the maxillary arch were done at five-time points over a 4-month follow-up period. The amount of canine movement, canine rotation, and anchorage loss were measured on three-dimensional digital models superimposed on the rugae area.

Detailed description: One of the most important goals of orthodontic treatment is to decrease the treatment time via achieving faster tooth movement chiefly in adults. Adults have more bone density and less bone turnover than adolescence, which may be linked to potential root resorption, periodontal problems, and white spot lesions.

Approaches to reduce orthodontic treatment time included surgical and non-surgical techniques. Non-surgical approaches such as systemic and local administration of chemical substances, low-level laser therapy, vibrations, and pulsed electrical stimulation therapy still need more studies to determine their safety and effectiveness.

Surgical procedures such as corticotomy, corticision, and micro-osteoperforations have

, in general high success rates, but they rely on incurring an injury to bone tissues. The latter has been linked to the regional acceleratory phenomenon (RAP). But the invasive nature of these procedures, associated risks of loss of alveolar bone and gingival recession, and the help needed from another specialist limit its routine application. Recently, the possibility of using platelet-based preparations from the patient's blood to accelerate orthodontic tooth movement like platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) has grown. PRF represents the second generation of biological materials derived from blood. It is obtained through a centrifuge of the patient's blood without adding any additives to the tube. The variety of growth factors in PRP and PRF may have the ability to stimulate the activation of osteoblasts and osteoclasts together, which supports the idea that PRP could affect orthodontic tooth movement The study sample consisted of 60 patients and was calculated using (G-power sample size calculator), depending on the rate of canine retraction with a study power of 90%.

After ensuring the patient's compliance with the terms and conditions of this study, the purpose and methods of the study were explained to the patients using Information Sheet. In case of approval to participate, the patients were asked to sign the informed consent. Extra \& Intra-oral photographs, impressions and clinical examinations were made.

Canine retraction was initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side at the same time.

Eligibility criteria: Inclusion Criteria:

1. both male and female subjects
2. 18-25 years old
3. Class II Division 1 malocclusion, treated with extraction of the maxillary first premolars
4. Full permanent dentition
5. Good general and oral health

Exclusion Criteria:

1. extreme skeletal class II malocclusion, overjet \> 10 mm ANB\>7◦
2. diseases and medications that were likely to affect bone biology
3. poor oral hygiene
4. previous orthodontic treatment
5. smoking
6. coagulation disorders, or being treated with anticoagulants

Primary outcomes:
measure: Change in canine retraction rate
timeFrame: The estimation took place at five time points: the beginning of tooth movement (T0) and at 4, 8, 12, and 16 weeks following T0
Secondary outcomes:
measure: Change in the maxillary first molar position (anchorage loss)
timeFrame: T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction
measure: Change in canine rotation
timeFrame: T0: before the beginning of canine retraction; T1: after 4 weeks of retraction; T2: after 8 weeks of retraction; T3: after 12 weeks; and T4: after 16 weeks after the start of retraction
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: University of Damascus
Study officials:
affiliation: Department of orthodontics, Hama University, Syria
name: Ali Ammar, DDS, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of orthodontics, Hama University, Syria
name: Rabab al-Sabbagh, DDS,MSc,PhD
role: STUDY_DIRECTOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Mohammad Y Hajeer, DDS,MSc,PhD
role: STUDY_DIRECTOR
References:
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