Crowding of Anterior Maxillary TeethNCT07352241
Repeated Injections of i-PRF for Decreasing Root Resorption After the Orthodontic Treatment.
A study testing 4-time i-PRF injection group and Saline injection in people with Crowding of Anterior Maxillary Teeth, run by Damascus University at 1 site in Syria.
Trial summary
Mandibular incisor crowding is a frequent issue that prompts many adults to seek orthodontic treatment. The treatment may enhance patients' quality of life, facilitate dental plaque control, and improve the quality of periodontal tissue. Read more about this study
- Who is it for?
- Ages 17 to 25 years
- Conditions the study is for
- Crowding of Anterior Maxillary Teeth
- What is being tested?
- 4-time i-PRF injection group and Saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSyria
- Study dates
- 13 Jan 2024to 4 Aug 2025
- 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 17 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult patients aged between 17 and 28 years
- Class I malocclusion with moderate crowding (4-6 mm) according to Little's Irregularity Index (LII)
- Normal or inclination for mandibular incisors
- Complete permanent teeth.
Who cannot join
- Previous orthodontic treatment,
- Poor oral hygiene,
- Severe skeletal discrepancy,
- The presence of coagulation disorders or being under anticoagulant treatment.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, Faculty of Dentistry, University of Damsacus
Damascus, DM20 HAJ72
About this study
Official title: Effect of the Injectable Platelet-rich Fibrin on the Orthodontically Induced Apical Root Resorption Following Non-extraction-based Orthodontic Treatment in Adults: A Randomized Controlled Clinical Trial.
Mandibular incisor crowding is a frequent issue that prompts many adults to seek orthodontic treatment. The treatment may enhance patients' quality of life, facilitate dental plaque control, and improve the quality of periodontal tissue. However, this treatment is accompanied by several side effects, including resorption of the apical portion of the teeth. Platelet-rich concentrates, such as injectable platelet-rich fibrin, have been shown to have positive effects on both soft- and hard-tissue healing. They may serve as a beneficial self-derived material to prevent this complication.
Read the detailed description
In recent years, increasing attention has been directed toward biologically driven approaches to modulate tissue responses during orthodontic treatment and minimize adverse effects, such as root resorption. Platelet-rich fibrin (PRF), a second-generation autologous platelet concentrate, has emerged as a promising biomaterial due to its high concentration of platelets, leukocytes, and a fibrin matrix that allows gradual release of multiple growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-β (TGF-β), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). However, in 2014, injectable platelet-rich fibrin (I-PRF), which is similar to PRF, was introduced in France by Choukroun, using non-glass tubes and adjusting the centrifugal force. Just like traditional PRF, i-PRF contains high levels of growth factors, stem cells, leukocytes, and cytokines.
These growth factors play a crucial role in angiogenesis, tissue regeneration, modulation of inflammation, and bone remodeling, all of which are central processes in orthodontic tooth movement and periodontal healing.
- Conditions
- Crowding of Anterior Maxillary Teeth
- Being tested
- 4-time i-PRF injection group, Saline injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-time i-PRF injection groupProcedure or surgery
I-PRF will be injected in 4 sessions at 28-day intervals. The injection will administered submucosally in the buccal region of the lower incisors, using 2 ml of i-PRF per session (0.5 ml per incisor). Orthodontic wires will be sequenced until they reach 0.019×0.025-inch stainless steel.
Saline injectionProcedure or surgery
Saline serum will be injected in 4 sessions at 28-day intervals. The injection will be administered submucosally in the buccal region of the lower incisors, using 2 ml of i-PRF per session (0.5 ml per incisor). Orthodontic wires will be sequenced until they reach 0.019×0.025-inch stainless steel.
| Study group | Role | What they receive |
|---|---|---|
| 4-time i-PRF injection group | Experimental | I-PRF was injected in the buccal region of the mandibular incisors 4 sessions with 28-day interval. Receives: Procedure: 4-time i-PRF injection group |
| Control group | Placebo comparator | Saline serum was injected in the buccal region of the mandibular incisors 4 sessions with 28-day interval Receives: Procedure: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in root length
Root resorption (i.e., change in root length) will be measured by calculating the difference in the full linear length of each incisor (incisal edge to the apex) between two assessment times (in millimeters) using CBCT images.
Measured: First assessment time: one day before the commencement of treatment. Second assessment time: within one week following the leveling and alignment stage (The stage is expected to finish within 4 to six months after the beginning of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start13 Jan 2024
- Primary completion11 Sep 2024
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Crowding of Anterior Maxillary TeethStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad I. Idris, DDS, Principal investigator, Faculty of Dentistry, University of DamascusAhmad S. Burhan, DDS MSc PhD, Study director, Faculty of Dentistry, University of DamascusMohammad Y Hajeer, DDS MSc PhD, Study chair, Faculty of Dentistry, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352241
- Sponsor's protocol ID
- UDDS-Ortho-1-2026
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang M, McGrath C, Hagg U. The impact of malocclusion and its treatment on quality of life: a literature review. Int J Paediatr Dent. 2006 Nov;16(6):381-7. doi: 10.1111/j.1365-263X.2006.00768.x.
PubMed 17014535Valerio CS, Cardoso CAEA, Araujo EA, Zenobio EG, Manzi FR. Bone changes in the mandibular incisors after orthodontic correction of dental crowding without extraction: A cone-beam computed tomographic evaluation. Imaging Sci Dent. 2021 Jun;51(2):155-165. doi: 10.5624/isd.20200260. Epub 2021 Feb 9.
PubMed 34235061Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9.
PubMed 33653326Samandara A, Papageorgiou SN, Ioannidou-Marathiotou I, Kavvadia-Tsatala S, Papadopoulos MA. Evaluation of orthodontically induced external root resorption following orthodontic treatment using cone beam computed tomography (CBCT): a systematic review and meta-analysis. Eur J Orthod. 2019 Jan 23;41(1):67-79. doi: 10.1093/ejo/cjy027.
PubMed 29771300Idris MI, Burhan AS, Hajeer MY, Sultan K, Nawaya FR. Efficacy of the injectable platelet-rich fibrin (i-PRF) in gingival phenotype modification: a systematic review and meta-analysis of randomized controlled trials. BMC Oral Health. 2024 Nov 1;24(1):1331. doi: 10.1186/s12903-024-05109-5.
PubMed 39487452Idris MI, Burhan AS, Hajeer MY, Nawaya FR. Effect of injectable platelet-rich fibrin on orthodontically induced apical root resorption following non-extraction-based orthodontic treatment in adults: A randomized controlled clinical trial. J Int Med Res. 2026 May;54(5):3000605261452234. doi: 10.1177/03000605261452234. Epub 2026 May 31.
PubMed 42219245
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Injectable Platelet-rich Fibrin on the Orthodontically Induced Apical Root Resorption Following Non-extraction-based Orthodontic Treatment in Adults: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07352241
- Acronym / sponsor ID
- UDDS-Ortho-1-2026
- Conditions
- Crowding of Anterior Maxillary Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 20 Jan 2026 (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.
Mandibular incisor crowding is a frequent issue that prompts many adults to seek orthodontic treatment. The treatment may enhance patients' quality of life, facilitate dental plaque control, and improve the quality of periodontal tissue. However, this treatment is accompanied by several side effects, including resorption of the apical portion of the teeth. Platelet-rich concentrates, such as injectable platelet-rich fibrin, have been shown to have positive effects on both soft- and hard-tissue healing. They may serve as a beneficial self-derived material to prevent this complication.
Detailed description
In recent years, increasing attention has been directed toward biologically driven approaches to modulate tissue responses during orthodontic treatment and minimize adverse effects, such as root resorption. Platelet-rich fibrin (PRF), a second-generation autologous platelet concentrate, has emerged as a promising biomaterial due to its high concentration of platelets, leukocytes, and a fibrin matrix that allows gradual release of multiple growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-β (TGF-β), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). However, in 2014, injectable platelet-rich fibrin (I-PRF), which is similar to PRF, was introduced in France by Choukroun, using non-glass tubes and adjusting the centrifugal force. Just like traditional PRF, i-PRF contains high levels of growth factors, stem cells, leukocytes, and cytokines.
These growth factors play a crucial role in angiogenesis, tissue regeneration, modulation of inflammation, and bone remodeling, all of which are central processes in orthodontic tooth movement and periodontal healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-time i-PRF injection group | Experimental | Procedure: 4-time i-PRF injection groupI-PRF was injected in the buccal region of the mandibular incisors 4 sessions with 28-day interval. |
| Control group | Placebo comparator | Procedure: Saline injectionSaline serum was injected in the buccal region of the mandibular incisors 4 sessions with 28-day interval |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adult patients aged between 17 and 28 years
- Class I malocclusion with moderate crowding (4-6 mm) according to Little's Irregularity Index (LII)
- Normal or inclination for mandibular incisors
- Complete permanent teeth.
Key exclusion criteria (4 listed)
- Previous orthodontic treatment,
- Poor oral hygiene,
- Severe skeletal discrepancy,
- The presence of coagulation disorders or being under anticoagulant treatment.
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 |
|---|---|---|
| 4-time i-PRF injection groupI-PRF will be injected in 4 sessions at 28-day intervals. The injection will administered submucosally in the buccal region of the lower incisors, using 2 ml of i-PRF per session (0.5 ml per incisor). Orthodontic wires will be sequenced until they reach 0.019×0.025-inch stainless steel. | Procedure or surgery | 4-time i-PRF injection group |
| Saline injectionSaline serum will be injected in 4 sessions at 28-day intervals. The injection will be administered submucosally in the buccal region of the lower incisors, using 2 ml of i-PRF per session (0.5 ml per incisor). Orthodontic wires will be sequenced until they reach 0.019×0.025-inch stainless steel. | Procedure or surgery | Control group |
Primary outcome
Change in root length
Time frame: First assessment time: one day before the commencement of treatment. Second assessment time: within one week following the leveling and alignment stage (The stage is expected to finish within 4 to six months after the beginning of treatment)
Root resorption (i.e., change in root length) will be measured by calculating the difference in the full linear length of each incisor (incisal edge to the apex) between two assessment times (in millimeters) using CBCT images.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 17014535Zhang M, McGrath C, Hagg U. The impact of malocclusion and its treatment on quality of life: a literature review. Int J Paediatr Dent. 2006 Nov;16(6):381-7. doi: 10.1111/j.1365-263X.2006.00768.x.
- Background: PubMed 34235061Valerio CS, Cardoso CAEA, Araujo EA, Zenobio EG, Manzi FR. Bone changes in the mandibular incisors after orthodontic correction of dental crowding without extraction: A cone-beam computed tomographic evaluation. Imaging Sci Dent. 2021 Jun;51(2):155-165. doi: 10.5624/isd.20200260. Epub 2021 Feb 9.
- Background: PubMed 33653326Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9.
- Background: PubMed 29771300Samandara A, Papageorgiou SN, Ioannidou-Marathiotou I, Kavvadia-Tsatala S, Papadopoulos MA. Evaluation of orthodontically induced external root resorption following orthodontic treatment using cone beam computed tomography (CBCT): a systematic review and meta-analysis. Eur J Orthod. 2019 Jan 23;41(1):67-79. doi: 10.1093/ejo/cjy027.
- Background: PubMed 39487452Idris MI, Burhan AS, Hajeer MY, Sultan K, Nawaya FR. Efficacy of the injectable platelet-rich fibrin (i-PRF) in gingival phenotype modification: a systematic review and meta-analysis of randomized controlled trials. BMC Oral Health. 2024 Nov 1;24(1):1331. doi: 10.1186/s12903-024-05109-5.
- Derived from this study: PubMed 42219245Idris MI, Burhan AS, Hajeer MY, Nawaya FR. Effect of injectable platelet-rich fibrin on orthodontically induced apical root resorption following non-extraction-based orthodontic treatment in adults: A randomized controlled clinical trial. J Int Med Res. 2026 May;54(5):3000605261452234. doi: 10.1177/03000605261452234. Epub 2026 May 31.
- Individual participant dataSharing planned: No
Related trials for Crowding of Anterior Maxillary Teeth
Recruiting
Interceptive Maxillary Expansion to Relief Anterior Crowding in the Mixed Dentition
Crowding of Anterior Maxillary Teeth, Orthodontics, Interceptive
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.
Mohammad I. Idris, DDS principal investigator
Faculty of Dentistry, University of Damascus
Ahmad S. Burhan, DDS MSc PhD study director
Faculty of Dentistry, University of Damascus
Mohammad Y Hajeer, DDS MSc PhD study chair
Faculty of Dentistry, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-time i-PRF injection group and Saline injection in people with Crowding of Anterior Maxillary Teeth, run by Damascus University at 1 site in Syria.
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 4 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: finished, as of the sponsor's last update on 20 Jan 2026. 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 Syria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in root length (time frame: First assessment time: one day before the commencement of treatment. Second assessment time: within one week following the leveling and alignment stage (The stage is expected to finish within 4 to six months after the beginning of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07352241, which also lists 6 linked publications.
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 20 Jan 2026.