Thin Gingival BiotypeNCT05615155
Efficacy of C-PRF vs i-PRF in Thin Gingival Biotype Subjects
A study testing Platelets Rich Fibrin (i-PRF / C-PRF) in people with Thin Gingival Biotype, run by Sajjad Ahmed Shakir at 1 site in Iraq.
Trial summary
Randomized split mouth clinical trials study focused on comparing the efficacy of i-prf versus c-prf injections on gingival thickness and keratinized tissue width in subjects with thin gingival biotype. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thin Gingival Biotype
- What is being tested?
- Platelets Rich Fibrin (i-PRF / C-PRF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2022to 1 Nov 2022
- 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
- Age ≥18 years and no systemic disease or pregnancy.
- Non-smoker.
- Subjects with clinically healthy intact periodontium; bleeding on probing (BOP)<10%, probing pocket depth (PPD)≤3mm, intact periodontium (no probing attachment loss). (Chapple et al., 2018).
- Four non-adjacent sites of anterior region with thin gingival biotype (GT ≤ 1mm). (Patrick H. et al., 2018).
- No malocclusion, crowding, filling, missing or supernumerary mandibular anterior teeth.
- No blood-borne conditions.
- Any symptoms of recent acute illness e.g., COVID-19.
Who cannot join
- Active orthodontic treatment.
- Previous periodontal surgery.
- Use of blood thinners.
- Use of any drugs that might lead to gingival enlargement.
- Attrition.
- Gingival Recession.
- Thick gingival biotype.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of C-PRF Versus i-PRF on Gingival Thickness & Keratinized Tissue Width in Subjects With Thin Gingival Biotype: ( Split Mouth Controlled Clinical Trials)
Randomized split mouth clinical trials study focused on comparing the efficacy of i-prf versus c-prf injections on gingival thickness and keratinized tissue width in subjects with thin gingival biotype.
Read the detailed description
Randomized split mouth clinical trials study focused on comparing the efficacy of i-prf versus c-prf injections on gingival thickness and keratinized tissue width in subjects with thin gingival biotype.
Gingival biotype is an important clinical parameter that plays an important role in determining the gingival health in the future and the possibility of developing gingival recession or other gingival unhealthy condition that is related to thin gingival biotype.
Gingival biotype is consist of gingival thickness and keratinized tissue width, and its either thin or thick, and the later is more favourable to withstand the developing of gingival diseases and unhealthy condition, with this study we compare the effect of i-PRF injection which is approved in many previous clinical trials that it affects the gingival biotype and increases gingival thickness and the keratinized tissue width, and compare it to newly developed PRF generation (C-PRF) which is Concentrated Platelet Rich Fibrin.
- Conditions
- Thin Gingival Biotype
- Being tested
- Platelets Rich Fibrin (i-PRF / C-PRF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelets Rich Fibrin (i-PRF / C-PRF)Other
one site of the mouth will be injected with i-PRF and the other site will be injected with C-PRF
| Study group | Role | What they receive |
|---|---|---|
| i-PRF | Experimental | The sides of the mouth that will be injected with injectable-Platelets Rich Fibrin Receives: Other: Platelets Rich Fibrin (i-PRF / C-PRF) |
| C-PRF | Experimental | The sides of the mouth that will be injected with Concentrated-Platelets Rich Fibrin Receives: Other: Platelets Rich Fibrin (i-PRF / C-PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the mean differences gain of GT&KTW
the increase in gingival thickness and keratinized tissue width after the injection of prf concentrates.
Measured: baseline and 3 months
Secondary outcomes (1)
measure the mean difference gain of GT&KTW
the increase in gingival thickness and keratinized tissue width after the injection of prf concentrates.
Measured: baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Feb 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin Gingival BiotypeStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sajjad Ahmed Shakir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sajjad Ahmed Shakir, University of Baghdad
- Investigators
- Sajjad ah Shakir, BDS, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615155
- Sponsor's protocol ID
- Sajjad Ahmed Shakir
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the study will be published and shared for other researchers in medical journals.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of C-PRF Versus i-PRF on Gingival Thickness & Keratinized Tissue Width in Subjects With Thin Gingival Biotype: ( Split Mouth Controlled Clinical Trials)
- ClinicalTrials.gov ID
- NCT05615155
- Acronym / sponsor ID
- Sajjad Ahmed Shakir
- Conditions
- Thin Gingival Biotype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sajjad Ahmed ShakirUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 14 Nov 2022 (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.
Randomized split mouth clinical trials study focused on comparing the efficacy of i-prf versus c-prf injections on gingival thickness and keratinized tissue width in subjects with thin gingival biotype.
Detailed description
Randomized split mouth clinical trials study focused on comparing the efficacy of i-prf versus c-prf injections on gingival thickness and keratinized tissue width in subjects with thin gingival biotype.
Gingival biotype is an important clinical parameter that plays an important role in determining the gingival health in the future and the possibility of developing gingival recession or other gingival unhealthy condition that is related to thin gingival biotype.
Gingival biotype is consist of gingival thickness and keratinized tissue width, and its either thin or thick, and the later is more favourable to withstand the developing of gingival diseases and unhealthy condition, with this study we compare the effect of i-PRF injection which is approved in many previous clinical trials that it affects the gingival biotype and increases gingival thickness and the keratinized tissue width, and compare it to newly developed PRF generation (C-PRF) which is Concentrated Platelet Rich Fibrin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-PRF | Experimental | Other: Platelets Rich Fibrin (i-PRF / C-PRF)The sides of the mouth that will be injected with injectable-Platelets Rich Fibrin |
| C-PRF | Experimental | Other: Platelets Rich Fibrin (i-PRF / C-PRF)The sides of the mouth that will be injected with Concentrated-Platelets Rich Fibrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years and no systemic disease or pregnancy.
- Non-smoker.
- Subjects with clinically healthy intact periodontium; bleeding on probing (BOP)<10%, probing pocket depth (PPD)≤3mm, intact periodontium (no probing attachment loss). (Chapple et al., 2018).
- Four non-adjacent sites of anterior region with thin gingival biotype (GT ≤ 1mm). (Patrick H. et al., 2018).
- No malocclusion, crowding, filling, missing or supernumerary mandibular anterior teeth.
Key exclusion criteria (7 listed)
- Active orthodontic treatment.
- Previous periodontal surgery.
- Use of blood thinners.
- Use of any drugs that might lead to gingival enlargement.
- Attrition.
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 |
|---|---|---|
| Platelets Rich Fibrin (i-PRF / C-PRF)one site of the mouth will be injected with i-PRF and the other site will be injected with C-PRF | Other | C-PRF, i-PRF |
Primary outcome
measure the mean differences gain of GT&KTW
Time frame: baseline and 3 months
the increase in gingival thickness and keratinized tissue width after the injection of prf concentrates.
1 secondary outcome
measure the mean difference gain of GT&KTW
Time frame: baseline and 1 month
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 28 Nov 2023.
- Individual participant dataSharing planned: No. the study will be published and shared for other researchers in medical journals.
Related trials for Thin Gingival Biotype
Active, not recruiting
i-PRF for Gingival Phenotype Modification
Thin Gingival Biotype
Not yet recruiting
Efficacy of Microneedling With Hyaluronic Acid Injection for Gingival Augmentation in Thin Gingival Phenotype
Thin Gingival Biotype
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.
Sajjad ah Shakir, BDS principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelets Rich Fibrin (i-PRF / C-PRF) in people with Thin Gingival Biotype, run by Sajjad Ahmed Shakir at 1 site in Iraq.
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 7 inclusion and 7 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 28 Nov 2023. 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 Iraq. 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?
measure the mean differences gain of GT&KTW (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023.