Root ResorptionNCT06198322
Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on Root Resorption
A study testing Platelet-rich Fibrin and Vitamin D3 in people with Root Resorption, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This study aims to investigate and compare the effect of PRF and vitamin Dꝫ injections on root resorption by using CBCT Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Root Resorption
- What is being tested?
- Platelet-rich Fibrin and Vitamin D3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 11 May 2023to Apr 2024
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Active periodontal disease.
- Poor oral hygiene.
- Systemic diseases or medications that alter bone metabolism or tooth movement.
- Craniofacial anomalies
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Beni Suef University
Banī Suwayf
Rehab Khalil, 01005230669, rehababdelrazek@dent.bsu.edu.eg
About this study
Official title: Assessment of the Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on Root Resorption: A Randomized Controlled Clinical Trial
This study aims to investigate and compare the effect of PRF and vitamin Dꝫ injections on root resorption by using CBCT
Read the detailed description
- Participants will be recruited from the Faculty of Dentistry, Beni-Suef University. All subjects will be informed of the treatment procedures and will sign a consent form.
- Subjects will be randomly divided into two groups:
Group 1 (PRF group): upper canine retraction will be facilitated by PRF injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one.
Group II (Vitamin Dꝫ group): canine retraction will be facilitated by Vitamin Dꝫ injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one.
- The predicted sample size (n) was a total of (28) cases (i.e. 14 cases per group). Sample size calculation was performed using G*Power version 3.1.9.7
- Randomization:
Simple randomization will be designed with the aid of a computer-generated schedule with 1:1 allocation ratio. Allocation concealment will be achieved using identical opaque, sealed envelopes. Randomization and allocation concealment will be performed by one of the academic staff who will not be involved in the study and will keep the allocation table away from the operators. The operator will shuffle the sealed envelopes and will ask the patient to pick one envelope at the time of recruitment. In each group, a randomly selected side will act as the experimental side while the contralateral side will serve as the control. Blinding of the operators will not be applicable and so blinding will be limited to the outcome assessment.
- Methodology: All patients will be treated with a 0.022-inch MBT bracket system. Leveling and alignment phase will be completed until a 0.017 X 0.025'' stainless steel wire will be inserted passively into the bracket slot. Before canine retraction, the subject will be randomly assigned to one of the groups (PRF or Vitamin Dꝫ group). In both groups, canine retraction will be performed with closed Ni-Ti coil springs with a force of 150 g per side that will be adjusted by the use of a force gauge.
- Conditions
- Root Resorption
- Being tested
- Platelet-rich Fibrin, Vitamin D3
- Keywords
- platelet-rich fibrin, vitamin D3, root resorption
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich FibrinOther
Platelet-rich Fibrin will be injected distal to the canine on the experimental side
Vitamin D3Other
Vitamin D3 will be injected distal to the canine on the experimental side
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich Fibrin | Experimental | A 20 ml blood sample will be drawn from the median cubital vein into a PRF tube. Centrifugation will be done at 700 rpm for 3 minutes and the liquid of PRF will be suctioned out using a separate syringe. PRF will be injected distal to the canine on the experimental side three times; at the beginning of canine retraction (T0), 1 month after the start of canine retraction (T1), and 2 months after the start of canine retraction (T2). Receives: Other: Platelet-rich Fibrin |
| Vitamin D3 | Experimental | Subjects will receive vitamin Dꝫ injection distal to the canine on the experimental side three times; at the beginning of canine retraction (T0), 1 month after the start of canine retraction (T1), and 2 months after the start of canine retraction (T2). Receives: Other: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Assess the effect of using PRF and vitamin Dꝫ injections on root resorption and length and compare them by using CBCT.
Cone beam computed tomography (CBCT) will be obtained before treatment and after canine retraction to evaluate the severity of root resorption associated with the two techniques.
Measured: 3 - 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start11 May 2023
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Root ResorptionStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- split-mouth, prospective, single-center, single-blinded, two-arm randomized clinical trial with a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Abd El Razek Abd El Aziz Khalil, Beni-Suef University
- Investigators
- Rehab Khalil, Principal investigator, Faculty of Dentistry Beni Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198322
- Sponsor's protocol ID
- REC-FDBSU/P206042023-03/AR
- Status last verified
- Dec 2023
- First submitted
- 27 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nakano T, Hotokezaka H, Hashimoto M, Sirisoontorn I, Arita K, Kurohama T, Darendeliler MA, Yoshida N. Effects of different types of tooth movement and force magnitudes on the amount of tooth movement and root resorption in rats. Angle Orthod. 2014 Nov;84(6):1079-85. doi: 10.2319/121913-929.1. Epub 2014 Apr 22.
PubMed 24754797Kalra S, Gupta P, Tripathi T, Rai P. External apical root resorption in orthodontic patients: molecular and genetic basis. J Family Med Prim Care. 2020 Aug 25;9(8):3872-3882. doi: 10.4103/jfmpc.jfmpc_802_20. eCollection 2020 Aug.
PubMed 33110782Dudic A, Giannopoulou C, Meda P, Montet X, Kiliaridis S. Orthodontically induced cervical root resorption in humans is associated with the amount of tooth movement. Eur J Orthod. 2017 Oct 1;39(5):534-540. doi: 10.1093/ejo/cjw087.
PubMed 28339612Jiang RP, McDonald JP, Fu MK. Root resorption before and after orthodontic treatment: a clinical study of contributory factors. Eur J Orthod. 2010 Dec;32(6):693-7. doi: 10.1093/ejo/cjp165. Epub 2010 Mar 22.
PubMed 20308200Gupta P, Bhagyalakshmi A, Avinash BS, Prashant A, Raghunath N. Evaluation of injectable platelet-rich fibrin effect on the rate of canine retraction and alkaline phosphatase levels: An in-vivo study. Am J Orthod Dentofacial Orthop. 2022 Nov;162(5):735-743. doi: 10.1016/j.ajodo.2021.07.019. Epub 2022 Aug 23.
PubMed 36008239Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.
PubMed 33459765Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
PubMed 33481053Reyes Pacheco AA, Collins JR, Contreras N, Lantigua A, Pithon MM, Tanaka OM. Distalization rate of maxillary canines in an alveolus filled with leukocyte-platelet-rich fibrin in adults: A randomized controlled clinical split-mouth trial. Am J Orthod Dentofacial Orthop. 2020 Aug;158(2):182-191. doi: 10.1016/j.ajodo.2020.03.020. Epub 2020 Jun 24.
PubMed 32591274Zeitounlouian 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 33653326Varughese ST, Shamanna PU, Goyal N, Thomas BS, Lakshmanan L, Pulikkottil VJ, Ahmed MG. Effect of Vitamin D on Canine Distalization and Alveolar Bone Density Using Multi-slice Spiral CT: A Randomized Controlled Trial. J Contemp Dent Pract. 2019 Dec 1;20(12):1430-1435.
PubMed 32381845Al-Attar A, Abid M. The Effect of Vitamin D3 on the Alignment of Mandibular Anterior Teeth: A Randomized Controlled Clinical Trial. Int J Dent. 2022 Feb 14;2022:6555883. doi: 10.1155/2022/6555883. eCollection 2022.
PubMed 35198025Khalaf RM, Almudhi AA. Effects of vitamin D deficiency on the rate of orthodontic tooth movement: An animal study. Saudi Dent J. 2022 Feb;34(2):129-135. doi: 10.1016/j.sdentj.2021.12.008. Epub 2021 Dec 23.
PubMed 35241902Tehranchi A, Sadighnia A, Younessian F, Abdi AH, Shirvani A. Correlation of Vitamin D status and orthodontic-induced external apical root resorption. Dent Res J (Isfahan). 2017 Nov-Dec;14(6):403-411. doi: 10.4103/1735-3327.218565.
PubMed 29238379Azizi F, Karami N, Golshah A, Imani MM, Safari-Faramani R. Effect of Serum Level of Vitamin D on External Apical Root Resorption in Maxillary Anterior Teeth in Patients under Fixed Orthodontic Treatment. Int J Dent. 2022 Sep 27;2022:7942998. doi: 10.1155/2022/7942998. eCollection 2022.
PubMed 36203821Navya S, Prashantha GS, Sabrish S, Roshan MS, Mathew S. Evaluation of the effect of local administration of PRP vs vitamin D3 on the rate of orthodontic tooth movement and the associated external apical root resorption. J Oral Biol Craniofac Res. 2022 Nov-Dec;12(6):879-884. doi: 10.1016/j.jobcr.2022.09.011. Epub 2022 Oct 4.
PubMed 36250145
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on Root Resorption: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06198322
- Acronym / sponsor ID
- REC-FDBSU/P206042023-03/AR
- Conditions
- Root Resorption
- Keywords
- platelet-rich fibrin, vitamin D3, root resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 10 Jan 2024 (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.
This study aims to investigate and compare the effect of PRF and vitamin Dꝫ injections on root resorption by using CBCT
Detailed description
- Participants will be recruited from the Faculty of Dentistry, Beni-Suef University. All subjects will be informed of the treatment procedures and will sign a consent form.
- Subjects will be randomly divided into two groups:
Group 1 (PRF group): upper canine retraction will be facilitated by PRF injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one.
Group II (Vitamin Dꝫ group): canine retraction will be facilitated by Vitamin Dꝫ injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one.
- The predicted sample size (n) was a total of (28) cases (i.e. 14 cases per group). Sample size calculation was performed using G*Power version 3.1.9.7
- Randomization:
Simple randomization will be designed with the aid of a computer-generated schedule with 1:1 allocation ratio. Allocation concealment will be achieved using identical opaque, sealed envelopes. Randomization and allocation concealment will be performed by one of the academic staff who will not be involved in the study and will keep the allocation table away from the operators. The operator will shuffle the sealed envelopes and will ask the patient to pick one envelope at the time of recruitment. In each group, a randomly selected side will act as the experimental side while the contralateral side will serve as the control. Blinding of the operators will not be applicable and so blinding will be limited to the outcome assessment.
- Methodology: All patients will be treated with a 0.022-inch MBT bracket system. Leveling and alignment phase will be completed until a 0.017 X 0.025'' stainless steel wire will be inserted passively into the bracket slot. Before canine retraction, the subject will be randomly assigned to one of the groups (PRF or Vitamin Dꝫ group). In both groups, canine retraction will be performed with closed Ni-Ti coil springs with a force of 150 g per side that will be adjusted by the use of a force gauge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- split-mouth, prospective, single-center, single-blinded, two-arm randomized clinical trial with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich Fibrin | Experimental | Other: Platelet-rich FibrinA 20 ml blood sample will be drawn from the median cubital vein into a PRF tube. Centrifugation will be done at 700 rpm for 3 minutes and the liquid of PRF will be suctioned out using a separate syringe. PRF will be injected distal to the canine on the experimental side three times; at the beginning of canine retraction (T0), 1 month after the start of canine retraction (T1), and 2 months after the start of canine retraction (T2). |
| Vitamin D3 | Experimental | Other: Vitamin D3Subjects will receive vitamin Dꝫ injection distal to the canine on the experimental side three times; at the beginning of canine retraction (T0), 1 month after the start of canine retraction (T1), and 2 months after the start of canine retraction (T2). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Active periodontal disease.
- Poor oral hygiene.
- Systemic diseases or medications that alter bone metabolism or tooth movement.
- Craniofacial anomalies
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 |
|---|---|---|
| Platelet-rich FibrinPlatelet-rich Fibrin will be injected distal to the canine on the experimental side | Other | Platelet-rich Fibrin |
| Vitamin D3Vitamin D3 will be injected distal to the canine on the experimental side | Other | Vitamin D3 |
Primary outcome
- Assess the effect of using PRF and vitamin Dꝫ injections on root resorption and length and compare them by using CBCT.
Time frame: 3 - 4 months
Cone beam computed tomography (CBCT) will be obtained before treatment and after canine retraction to evaluate the severity of root resorption associated with the two techniques.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 24754797Nakano T, Hotokezaka H, Hashimoto M, Sirisoontorn I, Arita K, Kurohama T, Darendeliler MA, Yoshida N. Effects of different types of tooth movement and force magnitudes on the amount of tooth movement and root resorption in rats. Angle Orthod. 2014 Nov;84(6):1079-85. doi: 10.2319/121913-929.1. Epub 2014 Apr 22.
- Background: PubMed 33110782Kalra S, Gupta P, Tripathi T, Rai P. External apical root resorption in orthodontic patients: molecular and genetic basis. J Family Med Prim Care. 2020 Aug 25;9(8):3872-3882. doi: 10.4103/jfmpc.jfmpc_802_20. eCollection 2020 Aug.
- Background: PubMed 28339612Dudic A, Giannopoulou C, Meda P, Montet X, Kiliaridis S. Orthodontically induced cervical root resorption in humans is associated with the amount of tooth movement. Eur J Orthod. 2017 Oct 1;39(5):534-540. doi: 10.1093/ejo/cjw087.
- Background: PubMed 20308200Jiang RP, McDonald JP, Fu MK. Root resorption before and after orthodontic treatment: a clinical study of contributory factors. Eur J Orthod. 2010 Dec;32(6):693-7. doi: 10.1093/ejo/cjp165. Epub 2010 Mar 22.
- Background: PubMed 36008239Gupta P, Bhagyalakshmi A, Avinash BS, Prashant A, Raghunath N. Evaluation of injectable platelet-rich fibrin effect on the rate of canine retraction and alkaline phosphatase levels: An in-vivo study. Am J Orthod Dentofacial Orthop. 2022 Nov;162(5):735-743. doi: 10.1016/j.ajodo.2021.07.019. Epub 2022 Aug 23.
- Background: PubMed 33459765Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.
- Background: PubMed 33481053Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
- Background: PubMed 32591274Reyes Pacheco AA, Collins JR, Contreras N, Lantigua A, Pithon MM, Tanaka OM. Distalization rate of maxillary canines in an alveolus filled with leukocyte-platelet-rich fibrin in adults: A randomized controlled clinical split-mouth trial. Am J Orthod Dentofacial Orthop. 2020 Aug;158(2):182-191. doi: 10.1016/j.ajodo.2020.03.020. Epub 2020 Jun 24.
- 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 32381845Varughese ST, Shamanna PU, Goyal N, Thomas BS, Lakshmanan L, Pulikkottil VJ, Ahmed MG. Effect of Vitamin D on Canine Distalization and Alveolar Bone Density Using Multi-slice Spiral CT: A Randomized Controlled Trial. J Contemp Dent Pract. 2019 Dec 1;20(12):1430-1435.
- Background: PubMed 35198025Al-Attar A, Abid M. The Effect of Vitamin D3 on the Alignment of Mandibular Anterior Teeth: A Randomized Controlled Clinical Trial. Int J Dent. 2022 Feb 14;2022:6555883. doi: 10.1155/2022/6555883. eCollection 2022.
- Background: PubMed 35241902Khalaf RM, Almudhi AA. Effects of vitamin D deficiency on the rate of orthodontic tooth movement: An animal study. Saudi Dent J. 2022 Feb;34(2):129-135. doi: 10.1016/j.sdentj.2021.12.008. Epub 2021 Dec 23.
- Individual participant dataSharing planned: No
Related trials for Root Resorption
Enrolling by invitation
Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair
Pain, Postoperative, Root Resorption
Active, not recruiting
Effects of PBM on Fixed-appliance Orthodontic Patients
Orthodontics, Root Resorption
Recruiting
3-D Evaluation of Alveolar Bone Changes and Root Resorption After Traction of Buccally Displaced Maxillary Canines
Malocclusion; Displaced Teeth
RecruitingObservational study
Clinical Investigation Measuring the Long Term Clinical Performance and Safety of Biodentine™ XP in Patients Treated for Coronal Restorative or Endodontic Dental Indications.
Dental Restoration, Permanent, Dental Restorations
Recruiting
Maxillary Incisor Intrusion Using Utility Arch Assisted With Micro-osteoperforations
Deep Bite Malocclusion, Intrusion of Tooth
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.
Rehab Khalil principal investigator
Faculty of Dentistry Beni Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich Fibrin and Vitamin D3 in people with Root Resorption, run by Beni-Suef 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 0 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. 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. 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 Rehab Khalil (01005230669, rehababdelrazek@dent.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Assess the effect of using PRF and vitamin Dꝫ injections on root resorption and length and compare them by using CBCT. (time frame: 3 - 4 months). 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 NCT06198322, which also lists 16 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 11 Jan 2024.