PeriodontoclasiaNCT03274674
Use of Injectable-platelet-rich-fibrin (I-PRF) to Thicken Gingival Phenotype
A study testing I-PRF in people with Periodontoclasia and Gingiva; Injury, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The main objective of this study is to investigate whether the for individuals with thin gingival thickness who are susceptible to gingival recession, the investigators will use i-PRF with microneedle to increase gingival thickness without the need for surgical procedures Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontoclasia, Gingiva; Injury, Condition
- What is being tested?
- I-PRF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2017to 1 Jun 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Never smokers
- Had no history of systemic disease
- Aged ≥18 years old
Who cannot join
- Patients with a history of diabetes mellitus or systemic disease
- Patients who were under any medication that was known to influence periodontal tissues
- Patients with hormonal changes such as pregnancy or lactation
- Toothless individuals
- Patients who were clotting disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Approach to Increasing Gingival Thickness in Individuals With Fine Gingival Phenotype:Injectable Platelet Rich Fibrin (I-PRF)
The main objective of this study is to investigate whether the for individuals with thin gingival thickness who are susceptible to gingival recession, the investigators will use i-PRF with microneedle to increase gingival thickness without the need for surgical procedures
Read the detailed description
Due to the thin gingival phenotype, gingival recession is a problem. The investigators aimed to increase the gingival thickness using i-PRF with microneedle without considering surgical procedures, considering the positive effects of platelet concentrations on revascularization and wound healing in individuals with bone defect, fenestration and gingival thickness which are prone to gingival recession .
- Conditions
- Periodontoclasia, Gingiva; Injury, Condition, Blood Clot, Gingiva Disorder
- Being tested
- I-PRF
- Keywords
- PRF, I-PRF, Microneedle, Gingival Thickness, Injectable-Platelet-Rich-Fibrin, Platelet Rich Fibrin
- Medical subject headings
- Wounds and Injuries, Disease, Thrombosis, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-PRFOther
Also called I-PRF and Microneedling
Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.I-PRF injected on one side of bilateral thin gingival thickness.Microneedle application plus I-PRF injected on the other side in patients with bilateral region with thin gingival phenotype.Apply once a week and one month after the end of the injections, the patient will be called to the control.
| Study group | Role | What they receive |
|---|---|---|
| I-PRF | Experimental | Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.I-PRF injected on one side of bilateral thin gingival thickness.Apply once a week and one month after the end of the injections, the patient will be called to the control. Receives: Other: I-PRF |
| I-PRF and Microneedling | Active comparator | Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.Microneedle application plus I-PRF injected on the other side in patients with bilateral region with thin gingival phenotype.Apply once a week and one month after the end of the injections, the patient will be called to the control. Receives: Other: I-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival thickness (mm)
Change in clinical measures of gingival thickness
Measured: 2 months
Secondary outcomes (5)
Plaque Index (PI)
Change in clinical measures of gingival parameters
Measured: 2 months
Gingival Index (GI)
Change in clinical measures of gingival parameters
Measured: 2 months
Bleeding on probing (BOP)
Change in clinical measures of gingival parameters
Measured: 2 months
Clinical attachment level (CAL)
Change in clinical measures of gingival parameters
Measured: 2 months
Probing pocket depth (PD)
Change in clinical measures of gingival parameters
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start4 Apr 2017
- Primary completion1 Jan 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontoclasiaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Blinded, Parallel group, Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeliha Betül Özsağır, Study chair, Bezmialem VU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274674
- Sponsor's protocol ID
- boz002
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2017
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozsagir ZB, Saglam E, Sen Yilmaz B, Choukroun J, Tunali M. Injectable platelet-rich fibrin and microneedling for gingival augmentation in thin periodontal phenotype: A randomized controlled clinical trial. J Clin Periodontol. 2020 Apr;47(4):489-499. doi: 10.1111/jcpe.13247. Epub 2020 Feb 11.
PubMed 31912532
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approach to Increasing Gingival Thickness in Individuals With Fine Gingival Phenotype:Injectable Platelet Rich Fibrin (I-PRF)
- ClinicalTrials.gov ID
- NCT03274674
- Acronym / sponsor ID
- boz002
- Conditions
- Periodontoclasia, Gingiva; Injury, Condition, Blood Clot, Gingiva Disorder
- Keywords
- PRF, I-PRF, Microneedle, Gingival Thickness, Injectable-Platelet-Rich-Fibrin, Platelet Rich Fibrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 7 Sep 2017 (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 main objective of this study is to investigate whether the for individuals with thin gingival thickness who are susceptible to gingival recession, the investigators will use i-PRF with microneedle to increase gingival thickness without the need for surgical procedures
Detailed description
Due to the thin gingival phenotype, gingival recession is a problem. The investigators aimed to increase the gingival thickness using i-PRF with microneedle without considering surgical procedures, considering the positive effects of platelet concentrations on revascularization and wound healing in individuals with bone defect, fenestration and gingival thickness which are prone to gingival recession .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Blinded, Parallel group, Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| I-PRF | Experimental | Other: I-PRFVenous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.I-PRF injected on one side of bilateral thin gingival thickness.Apply once a week and one month after the end of the injections, the patient will be called to the control. |
| I-PRF and Microneedling | Active comparator | Other: I-PRFVenous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.Microneedle application plus I-PRF injected on the other side in patients with bilateral region with thin gingival phenotype.Apply once a week and one month after the end of the injections, the patient will be called to the control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Never smokers
- Had no history of systemic disease
- Aged ≥18 years old
Key exclusion criteria (5 listed)
- Patients with a history of diabetes mellitus or systemic disease
- Patients who were under any medication that was known to influence periodontal tissues
- Patients with hormonal changes such as pregnancy or lactation
- Toothless individuals
- Patients who were clotting disorders
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 |
|---|---|---|
| I-PRFAlso: I-PRF and MicroneedlingVenous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.I-PRF injected on one side of bilateral thin gingival thickness.Microneedle application plus I-PRF injected on the other side in patients with bilateral region with thin gingival phenotype.Apply once a week and one month after the end of the injections, the patient will be called to the control. | Other | I-PRF, I-PRF and Microneedling |
Primary outcome
Gingival thickness (mm)
Time frame: 2 months
Change in clinical measures of gingival thickness
5 secondary outcomes
Plaque Index (PI)
Time frame: 2 months
Gingival Index (GI)
Time frame: 2 months
Bleeding on probing (BOP)
Time frame: 2 months
Clinical attachment level (CAL)
Time frame: 2 months
Probing pocket depth (PD)
Time frame: 2 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 9 Sep 2020.
- Derived from this study: PubMed 31912532Ozsagir ZB, Saglam E, Sen Yilmaz B, Choukroun J, Tunali M. Injectable platelet-rich fibrin and microneedling for gingival augmentation in thin periodontal phenotype: A randomized controlled clinical trial. J Clin Periodontol. 2020 Apr;47(4):489-499. doi: 10.1111/jcpe.13247. Epub 2020 Feb 11.
- Individual participant dataSharing planned: Undecided
Related trials for Periodontoclasia
Recruiting
A Chitosan Brush and Enamel Matrix Derivative for Non-surgical Treatment of Furcations
Periodontitis, Adult, Furcation Defects
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.
Zeliha Betül Özsağır study chair
Bezmialem VU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-PRF in people with Periodontoclasia and Gingiva; Injury, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. 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 Turkey (Türkiye). 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?
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?
Gingival thickness (mm) (time frame: 2 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 NCT03274674, which also lists 1 linked publication.
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 9 Sep 2020.