Bone ResorptionPhase 1NCT03028038
Using Platelet Rich Plasma in Reducing Alveolar Bone Resorption During Rapid Maxillary Expansion
A Phase 1 study testing Platelet Rich Plasma and No Platelet Rich Plasma in people with Bone Resorption, run by Damascus University at 1 site in Syria.
Trial summary
The purpose of this study is to determine if the injection of Platelet-rich plasma (PRP) is effective in reducing alveolar bone loss that happens after each rapid maxillary expansion (RME) on the buccal aspect of the posterior teeth. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Platelet Rich Plasma and No Platelet Rich Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSyria
- Study dates
- Jul 2016to 15 Jul 2018
- Phase
- Phase 1
- 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 10-16 years old patients
- Complete emergence of first molars and first premolars
- Clinical maxillary transverse deficiency
- Good oral hygiene (Gingival index <1) according to Silness \& loe 1964
- ( Plaque index <1)
Who cannot join
- The presence of a medical situations that affects orthodontic treatment and periodontal health
- The presence of drug therapy affect orthodontic treatment and periodontal health
- Bad oral hygiene (gingival and plaque index >1)
- Patient with physical and psychological limitations
- Metallic restorations or endodontic treatments on the appliance supporting teeth (first molars and first premolars)
- Craniofacial anomalies
Show all 11Show fewer
- Previous orthodontic treatment
- Patients who did not correctly follow the protocol of activation
- Patients who did not return for control dental appointments
- Patients whose cementation of the appliance failed
- Patients whose dental structures were difficult to visualize on the CBCT scans as a result of artifact
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy of Injectable Platelet-Rich Plasma (PRP) in Reducing Alveolar Bone Resorption Following Rapid Maxillary Expansion (RME): A Cone Beam Computed Tomography (CBCT) Assessment
The purpose of this study is to determine if the injection of Platelet-rich plasma (PRP) is effective in reducing alveolar bone loss that happens after each rapid maxillary expansion (RME) on the buccal aspect of the posterior teeth.
16 patients with a skeletal maxillary constriction aged between 10-16 years old will get into orthodontic treatment to widen the maxilla using Hyrax appliance.
Read more
An amount of patient blood will be withdrawn and centrifuged to get PRP. Then the PRP will be injected in one half of each patient mouth in a split-mouth design, beneath the buccal periosteal of the first molars and first premolars, the halves will be chosen randomly.
High resolution CBCT images will be taken before and after orthodontic treatment to analyze buccal bone thickness and height changes.
Read the detailed description
Correction of the maxillary transverse discrepancy is essential for treatment of various types of malocclusions. Palatal expansion is the most common method used to improve the transverse dimensions of the maxilla especially Rapid maxillary expansion (RME) . RME is associated with intermittent high force systems which cause lateral flexion of the alveolar processes and buccal displacement of the anchorage teeth . Displacement of these teeth outside the alveolar anatomic limits can damage the periodontium and finally compromising tooth longevity.
Several researchers have studied the incidence of buccal dehiscence and fenestrations after RME , using CBCT Images.
From here It was thought about using a method to eliminate these dangerous side effects. It was found that platelet rich plasma (PRP) has the ability to enhance tissue regeneration, accelerate wound healing and inducing stem cells differentiation through its growth factors (GFs).
This is the first study in the world that will use PRP with orthodontic treatment, because of its benefits and easiness of using in dental clinic.
Study sample, that consists of 16 patients, was calculated using (G-power sample size calculator) depending on the buccal alveolar bone thickness changes, with a study power of 95%.
Sample will be chosen from the patients who are coming to Orthodontic department in the Faculty of dentistry - Damascus university.
Allocation of the sides of intervention (PRP injection) and control sides is made by letting the participants to withdraw a closed envelop from a dark black box. Each envelop in the box contain either (R letter) for the right side or (L letter) for the left side that will be the intervention side for that patient.
After ensuring of the patients compliance with the terms and conditions of this study, the purpose and methods of the study will be explained to the patients using Information Sheet . In case of approval to participate the patients asked to sign the Informed Consent.
Extra \& Intra-oral photographs , impressions and clinical examination will be made.
High resolution CBCT will be taken before the beginning of treatment (T0). Hyrax appliance will be applied on the first molars and first premolars and cemented using GIC.
After one day of cementation, 20ml of patients' blood will be withdrawn and centrifuged to get 4 ml of PRP.
The buccal soft tissue will be anesthetized (sub-mucosal) in the intervention side , then the PRP will be injected at the buccal area of the first molar and first premolar in that side using insulin syringe , 2 ml for each tooth mentioned in two points. The first point place is in the middle of the attached gingiva over the mesial root of the first molar and buccal root of the first premolar. The second point is in the mucosal-gingival junction over the same root of each tooth.
Starting of expansion will be done in the same day of injection, twice a day until getting an over correction of 2-3 mm.
After one week, the injection of prp will be repeated in the same way (T1) High resolution CBCT for the maxilla will be taken 3 months after the beginning of treatment (T2).
All measures will be analyzed before and after treatment between two sides. A questionnaire will be given to the patients to study pain level accompanying PRP injection compared to the control side . Pain will be assessed using Visual Analogue Scale (VAS) 1 (No Pain) - 10 (Worst Pain).
A questionnaire will be given to the patients to study their acceptance of new treatment approach with comprehensive orthodontic treatments.
- Conditions
- Bone Resorption
- Being tested
- Platelet Rich Plasma, No Platelet Rich Plasma
- Keywords
- Platelet-rich plasma, Rapid maxillary expansion, Buccal bone thickness, Alveolar bone loss, Alveolar bone resorption
- Medical subject headings
- Bone Resorption, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaDrug
Also called PRP
Platelet Rich Plasma (PRP) will be injected beneath the buccal periosteal of the first molar and premolar in one mouth side with a split-mouth design before the beginning of Rapid Maxillary Expansion and after 7 days of it.
High resolution cone beam computed tomography (CBCT) will be taken before treatment and after 3 months when the Hyrax is removed.
No Platelet Rich PlasmaDrug
Also called No PRP
No Platelet Rich Plasma (PRP) will be injected in the other mouth side with a split-mouth design during Rapid Maxillary Expansion.
High resolution cone beam computed tomography (CBCT) will be taken before treatment and after 3 months when the Hyrax is removed.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma | Experimental | Platelet Rich Plasma (PRP) will be injected beneath the buccal periosteal of the first molar and premolar in one mouth side with a split-mouth design before the beginning of Rapid Maxillary Expansion and after 7 days of it. Receives: Drug: Platelet Rich Plasma |
| No Platelet Rich Plasma | Experimental | No Platelet Rich Plasma (PRP) will be injected in the other mouth side with a split-mouth design during Rapid Maxillary Expansion. Receives: Drug: No Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in buccal alveolar bone height loss and thickness reduction amount
Buccal alveolar bone height loss and thickness reduction amount (The incidence of Dehiscence) as a result of RME (On the intervention compared to non-intervention side) before and after expansion. Assessment will be done using CBCT before treatment (T0) and after 3 months (T2)
Measured: Evaluation before and after RME. (after 3 months)
Secondary outcomes (3)
Changes in the appliance supporting teeth inclination
The changes in the appliance supporting teeth inclination before and after 3 months of orthodontic expansion. Assessment will be done using CBCT before treatment (T0) and after 3 months (T2)
Measured: Evaluation before and after RME. (after 3 months)
Pain levels
Pain levels accompanying new treatment approach within orthodontic treatment. A questionnaire will be given to the patients on the first day after PRP first injection and after 3 days , 7 days, after 3 months
Measured: 3 months
Patient acceptance
Patient acceptance of the PRP injection during comprehensive orthodontic treatments.A questionnaire will be given to the patients on the first day after Prp first injection and after 3 days , 7 days, after 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionMay 2017
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Bone ResorptionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kinda Sultan, MSc, PhD, Study chair, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028038
- Sponsor's protocol ID
- UDDS-Ortho-04-2016
- Status last verified
- Jul 2018
- First submitted
- 18 Jan 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Agarwal A, Gupta ND. Platelet-rich plasma combined with decalcified freeze-dried bone allograft for the treatment of noncontained human intrabony periodontal defects: a randomized controlled split-mouth study. Int J Periodontics Restorative Dent. 2014 Sep-Oct;34(5):705-11. doi: 10.11607/prd.1766.
PubMed 25171042Akin M, Baka ZM, Ileri Z, Basciftci FA. Alveolar bone changes after asymmetric rapid maxillary expansion. Angle Orthod. 2015 Sep;85(5):799-805. doi: 10.2319/090214.1. Epub 2014 Dec 5.
PubMed 25478739Albanese A, Licata ME, Polizzi B, Campisi G. Platelet-rich plasma (PRP) in dental and oral surgery: from the wound healing to bone regeneration. Immun Ageing. 2013 Jun 13;10(1):23. doi: 10.1186/1742-4933-10-23.
PubMed 23763951Baysal A, Uysal T, Veli I, Ozer T, Karadede I, Hekimoglu S. Evaluation of alveolar bone loss following rapid maxillary expansion using cone-beam computed tomography. Korean J Orthod. 2013 Apr;43(2):83-95. doi: 10.4041/kjod.2013.43.2.83. Epub 2013 Apr 25.
PubMed 23671833Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.
PubMed 25722595DurmuSlar MC, Alpaslan C, Alpaslan G, Cakir M. Clinical and radiographic evaluation of the efficacy of platelet-rich plasma combined with hydroxyapatite bone graft substitutes in the treatment of intra-bony defects in maxillofacial region. Acta Odontol Scand. 2014 Nov;72(8):948-53. doi: 10.3109/00016357.2014.926023. Epub 2014 Jul 9.
PubMed 25005628Geramy A, Shahroudi AS. Fixed versus Removable Appliance for Palatal Expansion; A 3D Analysis Using the Finite Element Method. J Dent (Tehran). 2014 Jan;11(1):75-84. Epub 2014 Jan 31.
PubMed 24910679Gunyuz Toklu M, Germec-Cakan D, Tozlu M. Periodontal, dentoalveolar, and skeletal effects of tooth-borne and tooth-bone-borne expansion appliances. Am J Orthod Dentofacial Orthop. 2015 Jul;148(1):97-109. doi: 10.1016/j.ajodo.2015.02.022.
PubMed 26124033Lin L, Ahn HW, Kim SJ, Moon SC, Kim SH, Nelson G. Tooth-borne vs bone-borne rapid maxillary expanders in late adolescence. Angle Orthod. 2015 Mar;85(2):253-62. doi: 10.2319/030514-156.1. Epub 2014 Dec 9.
PubMed 25490552Martinez CE, Gonzalez SA, Palma V, Smith PC. Platelet-Poor and Platelet-Rich Plasma Stimulate Bone Lineage Differentiation in Periodontal Ligament Stem Cells. J Periodontol. 2016 Feb;87(2):e18-26. doi: 10.1902/jop.2015.150360. Epub 2015 Sep 14.
PubMed 26367495Alomari EB, Sultan K. Efficacy of injectable platelet-rich plasma in reducing alveolar bone resorption following rapid maxillary expansion: A cone-beam computed tomography assessment in a randomized split-mouth controlled trial. Angle Orthod. 2019 Sep;89(5):705-712. doi: 10.2319/091018-661.1. Epub 2019 Mar 28.
PubMed 30920874
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Injectable Platelet-Rich Plasma (PRP) in Reducing Alveolar Bone Resorption Following Rapid Maxillary Expansion (RME): A Cone Beam Computed Tomography (CBCT) Assessment
- ClinicalTrials.gov ID
- NCT03028038
- Acronym / sponsor ID
- UDDS-Ortho-04-2016
- Conditions
- Bone Resorption
- Keywords
- Platelet-rich plasma, Rapid maxillary expansion, Buccal bone thickness, Alveolar bone loss, Alveolar bone resorption
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 23 Jan 2017 (estimated)
- 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 purpose of this study is to determine if the injection of Platelet-rich plasma (PRP) is effective in reducing alveolar bone loss that happens after each rapid maxillary expansion (RME) on the buccal aspect of the posterior teeth.
16 patients with a skeletal maxillary constriction aged between 10-16 years old will get into orthodontic treatment to widen the maxilla using Hyrax appliance.
An amount of patient blood will be withdrawn and centrifuged to get PRP. Then the PRP will be injected in one half of each patient mouth in a split-mouth design, beneath the buccal periosteal of the first molars and first premolars, the halves will be chosen randomly.
High resolution CBCT images will be taken before and after orthodontic treatment to analyze buccal bone thickness and height changes.
Detailed description
Correction of the maxillary transverse discrepancy is essential for treatment of various types of malocclusions. Palatal expansion is the most common method used to improve the transverse dimensions of the maxilla especially Rapid maxillary expansion (RME) . RME is associated with intermittent high force systems which cause lateral flexion of the alveolar processes and buccal displacement of the anchorage teeth . Displacement of these teeth outside the alveolar anatomic limits can damage the periodontium and finally compromising tooth longevity.
Several researchers have studied the incidence of buccal dehiscence and fenestrations after RME , using CBCT Images.
From here It was thought about using a method to eliminate these dangerous side effects. It was found that platelet rich plasma (PRP) has the ability to enhance tissue regeneration, accelerate wound healing and inducing stem cells differentiation through its growth factors (GFs).
This is the first study in the world that will use PRP with orthodontic treatment, because of its benefits and easiness of using in dental clinic.
Study sample, that consists of 16 patients, was calculated using (G-power sample size calculator) depending on the buccal alveolar bone thickness changes, with a study power of 95%.
Sample will be chosen from the patients who are coming to Orthodontic department in the Faculty of dentistry - Damascus university.
Allocation of the sides of intervention (PRP injection) and control sides is made by letting the participants to withdraw a closed envelop from a dark black box. Each envelop in the box contain either (R letter) for the right side or (L letter) for the left side that will be the intervention side for that patient.
After ensuring of the patients compliance with the terms and conditions of this study, the purpose and methods of the study will be explained to the patients using Information Sheet . In case of approval to participate the patients asked to sign the Informed Consent.
Extra \& Intra-oral photographs , impressions and clinical examination will be made.
High resolution CBCT will be taken before the beginning of treatment (T0). Hyrax appliance will be applied on the first molars and first premolars and cemented using GIC.
After one day of cementation, 20ml of patients' blood will be withdrawn and centrifuged to get 4 ml of PRP.
The buccal soft tissue will be anesthetized (sub-mucosal) in the intervention side , then the PRP will be injected at the buccal area of the first molar and first premolar in that side using insulin syringe , 2 ml for each tooth mentioned in two points. The first point place is in the middle of the attached gingiva over the mesial root of the first molar and buccal root of the first premolar. The second point is in the mucosal-gingival junction over the same root of each tooth.
Starting of expansion will be done in the same day of injection, twice a day until getting an over correction of 2-3 mm.
After one week, the injection of prp will be repeated in the same way (T1) High resolution CBCT for the maxilla will be taken 3 months after the beginning of treatment (T2).
All measures will be analyzed before and after treatment between two sides. A questionnaire will be given to the patients to study pain level accompanying PRP injection compared to the control side . Pain will be assessed using Visual Analogue Scale (VAS) 1 (No Pain) - 10 (Worst Pain).
A questionnaire will be given to the patients to study their acceptance of new treatment approach with comprehensive orthodontic treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma | Experimental | Drug: Platelet Rich PlasmaPlatelet Rich Plasma (PRP) will be injected beneath the buccal periosteal of the first molar and premolar in one mouth side with a split-mouth design before the beginning of Rapid Maxillary Expansion and after 7 days of it. |
| No Platelet Rich Plasma | Experimental | Drug: No Platelet Rich PlasmaNo Platelet Rich Plasma (PRP) will be injected in the other mouth side with a split-mouth design during Rapid Maxillary Expansion. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 10-16 years old patients
- Complete emergence of first molars and first premolars
- Clinical maxillary transverse deficiency
- Good oral hygiene (Gingival index <1) according to Silness \& loe 1964
- ( Plaque index <1)
Key exclusion criteria (11 listed)
- The presence of a medical situations that affects orthodontic treatment and periodontal health
- The presence of drug therapy affect orthodontic treatment and periodontal health
- Bad oral hygiene (gingival and plaque index >1)
- Patient with physical and psychological limitations
- Metallic restorations or endodontic treatments on the appliance supporting teeth (first molars and first premolars)
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 PlasmaAlso: PRPPlatelet Rich Plasma (PRP) will be injected beneath the buccal periosteal of the first molar and premolar in one mouth side with a split-mouth design before the beginning of Rapid Maxillary Expansion and after 7 days of it. High resolution cone beam computed tomography (CBCT) will be taken before treatment and after 3 months when the Hyrax is removed. | Drug | Platelet Rich Plasma |
| No Platelet Rich PlasmaAlso: No PRPNo Platelet Rich Plasma (PRP) will be injected in the other mouth side with a split-mouth design during Rapid Maxillary Expansion. High resolution cone beam computed tomography (CBCT) will be taken before treatment and after 3 months when the Hyrax is removed. | Drug | No Platelet Rich Plasma |
Primary outcome
Changes in buccal alveolar bone height loss and thickness reduction amount
Time frame: Evaluation before and after RME. (after 3 months)
Buccal alveolar bone height loss and thickness reduction amount (The incidence of Dehiscence) as a result of RME (On the intervention compared to non-intervention side) before and after expansion. Assessment will be done using CBCT before treatment (T0) and after 3 months (T2)
3 secondary outcomes
Changes in the appliance supporting teeth inclination
Time frame: Evaluation before and after RME. (after 3 months)
Pain levels
Time frame: 3 months
Patient acceptance
Time frame: 3 months
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 30 Jul 2018.
- Results publication: PubMed 25171042Agarwal A, Gupta ND. Platelet-rich plasma combined with decalcified freeze-dried bone allograft for the treatment of noncontained human intrabony periodontal defects: a randomized controlled split-mouth study. Int J Periodontics Restorative Dent. 2014 Sep-Oct;34(5):705-11. doi: 10.11607/prd.1766.
- Results publication: PubMed 25478739Akin M, Baka ZM, Ileri Z, Basciftci FA. Alveolar bone changes after asymmetric rapid maxillary expansion. Angle Orthod. 2015 Sep;85(5):799-805. doi: 10.2319/090214.1. Epub 2014 Dec 5.
- Results publication: PubMed 23763951Albanese A, Licata ME, Polizzi B, Campisi G. Platelet-rich plasma (PRP) in dental and oral surgery: from the wound healing to bone regeneration. Immun Ageing. 2013 Jun 13;10(1):23. doi: 10.1186/1742-4933-10-23.
- Results publication: PubMed 23671833Baysal A, Uysal T, Veli I, Ozer T, Karadede I, Hekimoglu S. Evaluation of alveolar bone loss following rapid maxillary expansion using cone-beam computed tomography. Korean J Orthod. 2013 Apr;43(2):83-95. doi: 10.4041/kjod.2013.43.2.83. Epub 2013 Apr 25.
- Results publication: PubMed 25722595Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.
- Results publication: PubMed 25005628DurmuSlar MC, Alpaslan C, Alpaslan G, Cakir M. Clinical and radiographic evaluation of the efficacy of platelet-rich plasma combined with hydroxyapatite bone graft substitutes in the treatment of intra-bony defects in maxillofacial region. Acta Odontol Scand. 2014 Nov;72(8):948-53. doi: 10.3109/00016357.2014.926023. Epub 2014 Jul 9.
- Results publication: PubMed 24910679Geramy A, Shahroudi AS. Fixed versus Removable Appliance for Palatal Expansion; A 3D Analysis Using the Finite Element Method. J Dent (Tehran). 2014 Jan;11(1):75-84. Epub 2014 Jan 31.
- Results publication: PubMed 26124033Gunyuz Toklu M, Germec-Cakan D, Tozlu M. Periodontal, dentoalveolar, and skeletal effects of tooth-borne and tooth-bone-borne expansion appliances. Am J Orthod Dentofacial Orthop. 2015 Jul;148(1):97-109. doi: 10.1016/j.ajodo.2015.02.022.
- Results publication: PubMed 25490552Lin L, Ahn HW, Kim SJ, Moon SC, Kim SH, Nelson G. Tooth-borne vs bone-borne rapid maxillary expanders in late adolescence. Angle Orthod. 2015 Mar;85(2):253-62. doi: 10.2319/030514-156.1. Epub 2014 Dec 9.
- Results publication: PubMed 26367495Martinez CE, Gonzalez SA, Palma V, Smith PC. Platelet-Poor and Platelet-Rich Plasma Stimulate Bone Lineage Differentiation in Periodontal Ligament Stem Cells. J Periodontol. 2016 Feb;87(2):e18-26. doi: 10.1902/jop.2015.150360. Epub 2015 Sep 14.
- Derived from this study: PubMed 30920874Alomari EB, Sultan K. Efficacy of injectable platelet-rich plasma in reducing alveolar bone resorption following rapid maxillary expansion: A cone-beam computed tomography assessment in a randomized split-mouth controlled trial. Angle Orthod. 2019 Sep;89(5):705-712. doi: 10.2319/091018-661.1. Epub 2019 Mar 28.
- 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.
Kinda Sultan, MSc, PhD study chair
Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Platelet Rich Plasma and No Platelet Rich Plasma in people with Bone Resorption, 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 5 inclusion and 11 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 30 Jul 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in buccal alveolar bone height loss and thickness reduction amount (time frame: Evaluation before and after RME. (after 3 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 NCT03028038, which also lists 11 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 30 Jul 2018.