Periodontal HealthNCT06223477
Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on the Periodontal Health
A study testing Platelet-rich Fibrin and Vitamin D3 in people with Periodontal Health, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The study aims to evaluate the effect of using PRF and vitamin Dꝫ injections on periodontal health and parameters and compare them when used to facilitate orthodontic treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Periodontal Health
- 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
- Age: 18- 40 years old.
- Angle Class I or Class II dental malocclusion that required bilateral maxillary first premolar extraction and upper canine retraction as a part of the treatment plan.
- Good to fair oral hygiene.
- Normal probing depth.
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: Evaluation of the Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on the Periodontal Health During Canine Distalization: A Randomized Controlled Clinical Trial
The study aims to evaluate the effect of using PRF and vitamin Dꝫ injections on periodontal health and parameters and compare them when used to facilitate orthodontic treatment.
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
- 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
- Periodontal Health
- Being tested
- Platelet-rich Fibrin, Vitamin D3
- Keywords
- platelet-rich fibrin, vitamin D3, periodontal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich FibrinOther
PRF will be injected distal to the canine on the experimental side.
Vitamin D3Other
Vitamin Dꝫ 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.
Evaluate the effect of using PRF and Vitamin Dꝫ injections on periodontal health and compare them.
Clinical periodontal examination of the upper canines will be done before and after retraction on the experimental and control sides by recording the probing depth (PD).
- The probing depth will be measured from the gingival margin to the base of the gingival sulcus in millimeters by using a manual periodontal probe (William's probe). The measurements will be recorded at 6 sites around the tooth.
Measured: 3 - 4 months
Secondary outcomes (1)
Investigate the effect of PRF and Vitamin Dꝫ injections on the gingival thickness.
The gingival thickness will be recorded using an endodontic file with a stopper, which is placed horizontally, perpendicular to the long axis of the tooth on the labial gingiva.
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 posted25 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 (8)Papers the sponsor has linked to this study.
- Other trials for Periodontal HealthStudies 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
- NCT06223477
- Sponsor's protocol ID
- # REC-FDBSU/P106042023-03/AR
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta 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 36008239Cagli Karci I, Baka ZM. Assessment of the effects of local platelet-rich fibrin injection and piezocision on orthodontic tooth movement during canine distalization. Am J Orthod Dentofacial Orthop. 2021 Jul;160(1):29-40. doi: 10.1016/j.ajodo.2020.03.029. Epub 2021 May 4.
PubMed 33962809Zeitounlouian 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 33481053Varughese 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 32381845Bollen AM, Cunha-Cruz J, Bakko DW, Huang GJ, Hujoel PP. The effects of orthodontic therapy on periodontal health: a systematic review of controlled evidence. J Am Dent Assoc. 2008 Apr;139(4):413-22. doi: 10.14219/jada.archive.2008.0184.
PubMed 18385025Faour NH, Dayoub S, Hajeer MY. Evaluation of the Hyaluronic Acid Versus the Injectable Platelet-Rich Fibrin in the Management of the Thin Gingival Phenotype: A Split-Mouth Randomized Controlled Clinical Trial. Cureus. 2022 May 18;14(5):e25104. doi: 10.7759/cureus.25104. eCollection 2022 May.
PubMed 35607316Zeitounlouian 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 33653326Lu EM. The role of vitamin D in periodontal health and disease. J Periodontal Res. 2023 Apr;58(2):213-224. doi: 10.1111/jre.13083. Epub 2022 Dec 20.
PubMed 36537578
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Platelet-rich Fibrin and Vitamin Dꝫ Injections on the Periodontal Health During Canine Distalization: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06223477
- Acronym / sponsor ID
- # REC-FDBSU/P106042023-03/AR
- Conditions
- Periodontal Health
- Keywords
- platelet-rich fibrin, vitamin D3, periodontal health
- 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
- 25 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.
The study aims to evaluate the effect of using PRF and vitamin Dꝫ injections on periodontal health and parameters and compare them when used to facilitate orthodontic treatment.
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
- 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 (4 listed)
- Age: 18- 40 years old.
- Angle Class I or Class II dental malocclusion that required bilateral maxillary first premolar extraction and upper canine retraction as a part of the treatment plan.
- Good to fair oral hygiene.
- Normal probing depth.
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 FibrinPRF will be injected distal to the canine on the experimental side. | Other | Platelet-rich Fibrin |
| Vitamin D3Vitamin Dꝫ will be injected distal to the canine on the experimental side | Other | Vitamin D3 |
Primary outcome
Evaluate the effect of using PRF and Vitamin Dꝫ injections on periodontal health and compare them.
Time frame: 3 - 4 months
Clinical periodontal examination of the upper canines will be done before and after retraction on the experimental and control sides by recording the probing depth (PD). • The probing depth will be measured from the gingival margin to the base of the gingival sulcus in millimeters by using a manual periodontal probe (William's probe). The measurements will be recorded at 6 sites around the tooth.
1 secondary outcome
Investigate the effect of PRF and Vitamin Dꝫ injections on the gingival thickness.
Time frame: 3 - 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- 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 33962809Cagli Karci I, Baka ZM. Assessment of the effects of local platelet-rich fibrin injection and piezocision on orthodontic tooth movement during canine distalization. Am J Orthod Dentofacial Orthop. 2021 Jul;160(1):29-40. doi: 10.1016/j.ajodo.2020.03.029. Epub 2021 May 4.
- 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 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 18385025Bollen AM, Cunha-Cruz J, Bakko DW, Huang GJ, Hujoel PP. The effects of orthodontic therapy on periodontal health: a systematic review of controlled evidence. J Am Dent Assoc. 2008 Apr;139(4):413-22. doi: 10.14219/jada.archive.2008.0184.
- Background: PubMed 35607316Faour NH, Dayoub S, Hajeer MY. Evaluation of the Hyaluronic Acid Versus the Injectable Platelet-Rich Fibrin in the Management of the Thin Gingival Phenotype: A Split-Mouth Randomized Controlled Clinical Trial. Cureus. 2022 May 18;14(5):e25104. doi: 10.7759/cureus.25104. eCollection 2022 May.
- 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 36537578Lu EM. The role of vitamin D in periodontal health and disease. J Periodontal Res. 2023 Apr;58(2):213-224. doi: 10.1111/jre.13083. Epub 2022 Dec 20.
- Individual participant dataSharing planned: No
Related trials for Periodontal Health
Active, not recruiting
Influence of Implant Insertion Depth on Peri-implant Bone Changes Around Short Implants
Tooth Loss, Edentulism
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
RecruitingObservational study
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Edentulous Mouth, Quality of Life
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Not yet recruitingObservational study
Salivary and GCF Biomarkers in Periodontal Health, Gingivitis and Periodontitis
Periodontal Health, Gingivitis
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 Periodontal Health, 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 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: status not confirmed, as of the sponsor's last update on 25 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?
Evaluate the effect of using PRF and Vitamin Dꝫ injections on periodontal health and compare them. (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 NCT06223477, which also lists 8 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 25 Jan 2024.