Platelet-rich FibrinNCT05608356
Effect of Injectable Platelet-rich Fibrin on the En Masse Retraction of Maxillary Anterior Teeth
A study testing injectable platelet rich fibrin(i-prf) in people with Platelet-rich Fibrin, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet-rich Fibrin
- What is being tested?
- injectable platelet rich fibrin(i-prf)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Orthodontic patients with and age range (16 - 30) years.
- 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.
- Patients with full permanent dentition (with the exception of third molars).
- Healthy dental and periodontal condition with good oral hygiene
Who cannot join
- Patients with extensive restorations on the anterior teeth.
- Subjects taking medication affecting inflammatory process of the orthodontic tissue reaction.
- History of previous orthodontic treatment or trauma to the anterior teeth.
- Syndromic patients and patients with systemic diseases.
- Poor oral hygiene or periodontal diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Cairo University
Cairo, 11553
About this study
Official title: Effect of Injectable Platelet-rich Fibrin (i-PRF) on the Rate of Orthodontic En Masse Retraction of Maxillary Anterior Teeth: A Randomized Controlled Clinical Trial
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.
Read the detailed description
Trial will be carried on 2 groups, each involve 13 participants with a total of 26 participants.
- Subject examination to ensure he/she meets the eligibility criteria of the research.
- Leveling and alignment using fixed orthodontic appliance.
- Upper first premolars extraction as a part of the orthodontic treatment planning.
- 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.
- Conditions
- Platelet-rich Fibrin
- Being tested
- injectable platelet rich fibrin(i-prf), Sham Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable platelet rich fibrin(i-prf)Biological
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.
Sham InjectionDrug
Sham injection as a placebo injection
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Intervention group subjects will receive injectable platelet rich fibrin (i-prf) . The (i-prf) will be injected in the periodontal ligament of maxillary anterior teeth during en masse retraction.The injection sites will be the sites of bone compression to target the surfaces of the bone where osteoclastogenesis and bone resorption occurs during en masse retraction.
Considering that the obtained (i-prf) after centrifuging would be 4 ml, 1 ml will be injected intraligamentally distal to the right and left canines, and 0.5 ml will be injected intraligamentally palatal to each incisor. The study group will receive i-PRF intraligamentally in the periodontal ligament space of the maxillary six anterior teeth three times as follow, just before anterior teeth retraction, and after 21 days of the retraction, and after 42 days of the retraction. Before each time of injection, an anesthetic solution will be administered for pain control. Receives: Biological: injectable platelet rich fibrin(i-prf) |
| control group | Sham comparator | Subjects in the control group will only receive sham (placebo) injection three successive times with and interval of 21days between each injection, similar to the timepoints of (i-prf) injection in the intervention group. Also the sites of injection will be similar to the sites of injection of the intervention group; 1 ml of the placebo agent will be injected intraligamentally distal to the right and left canines, and 0.5 ml will be injected intraligamentally palatal to each incisor. An anesthetic solution will be administered for pain control before the administration of the sham injections. Receives: Drug: Sham Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of En masse retraction
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.
Measured: 4 months
Secondary outcomes (1)
Associated Pain
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-rich FibrinStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed magdy Mohamed Sabrah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608356
- Sponsor's protocol ID
- i-prf-en-masse-cu-2022-11-1
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Injectable Platelet-rich Fibrin (i-PRF) on the Rate of Orthodontic En Masse Retraction of Maxillary Anterior Teeth: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05608356
- Acronym / sponsor ID
- i-prf-en-masse-cu-2022-11-1
- Conditions
- Platelet-rich Fibrin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Subject examination to ensure he/she meets the eligibility criteria of the research.
- Leveling and alignment using fixed orthodontic appliance.
- Upper first premolars extraction as a part of the orthodontic treatment planning.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Biological: injectable platelet rich fibrin(i-prf)Intervention group subjects will receive injectable platelet rich fibrin (i-prf) . The (i-prf) will be injected in the periodontal ligament of maxillary anterior teeth during en masse retraction.The injection sites will be the sites of bone compression to target the surfaces of the bone where osteoclastogenesis and bone resorption occurs during en masse retraction. Considering that the obtained (i-prf) after centrifuging would be 4 ml, 1 ml will be injected intraligamentally distal to the right and left canines, and 0.5 ml will be injected intraligamentally palatal to each incisor. The study group will receive i-PRF intraligamentally in the periodontal ligament space of the maxillary six anterior teeth three times as follow, just before anterior teeth retraction, and after 21 days of the retraction, and after 42 days of the retraction. Before each time of injection, an anesthetic solution will be administered for pain control. |
| control group | Sham comparator | Drug: Sham InjectionSubjects in the control group will only receive sham (placebo) injection three successive times with and interval of 21days between each injection, similar to the timepoints of (i-prf) injection in the intervention group. Also the sites of injection will be similar to the sites of injection of the intervention group; 1 ml of the placebo agent will be injected intraligamentally distal to the right and left canines, and 0.5 ml will be injected intraligamentally palatal to each incisor. An anesthetic solution will be administered for pain control before the administration of the sham injections. |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Orthodontic patients with and age range (16 - 30) years.
- 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.
- Patients with full permanent dentition (with the exception of third molars).
- Healthy dental and periodontal condition with good oral hygiene
Key exclusion criteria (5 listed)
- Patients with extensive restorations on the anterior teeth.
- Subjects taking medication affecting inflammatory process of the orthodontic tissue reaction.
- History of previous orthodontic treatment or trauma to the anterior teeth.
- Syndromic patients and patients with systemic diseases.
- Poor oral hygiene or periodontal diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injectable 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. | Biological | intervention group |
| Sham InjectionSham injection as a placebo injection | Drug | control group |
Primary outcome
Rate of En masse retraction
Time frame: 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.
1 secondary outcome
Associated Pain
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injectable platelet rich fibrin(i-prf) in people with Platelet-rich Fibrin, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Sabrah, Master Degree of Orthodontics (+201063688954, ahmedmagdy25291@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of En masse retraction (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.