Thin Gingival PhenotypeNCT07682259
Super Putty C-PRF/ Hyaluronic Acid Combination vs C-PRF in Gingival Phenotype Modification in Subjects With Thin Gingival Phenotype
A study testing C-PRF and Hyaluronic Acid and C-PRF in people with Thin Gingival Phenotype, run by Sajjad Ahmed Shakir at 1 site in Iraq.
Trial summary
Randomized split mouth clinical trials study focused on comparing the efficacy of C-PRF/ Hyaluronic acid combination versus C-PRF injection alone in subjects with thin gingival phenotype. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Thin Gingival Phenotype
- What is being tested?
- C-PRF and Hyaluronic Acid and C-PRF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jul 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy male or female adults aged 20 to 40 years.
- Non-smoker.
- Presence of a clinically thin gingival phenotype (gingival thickness ≤ 1.0 mm) at the targeted surgical sites.
- Presence of bilateral homologous teeth (e.g., both maxillary canines, or both mandibular first premolars) exhibiting the same thin gingival phenotype to allow for paired test and control sites within the same oral cavity.
- Patients must demonstrate a high standard of oral hygiene, defined as a full-mouth plaque score and full-mouth bleeding score of ≤ 10% following initial cause-related therapy.
- Willingness to comply with the 6-month follow-up schedule and provide written informed consent before enrollment.
Who cannot join
- Any systemic disease or condition known to compromise wound healing or alter immune response (e.g., uncontrolled diabetes mellitus, autoimmune disorders, bleeding dyscrasias).
- Current or recent use of medications known to induce gingival enlargement (e.g., phenytoin, cyclosporine, calcium channel blockers) or medications affecting blood coagulation and platelet function (e.g., anticoagulants) within last 10 days of the procedure.
- Active periodontitis, defined by probing depths > 3 mm or bleeding on probing at the designated experimental sites
- Any previous history of mucogingival surgery, soft tissue grafting, or local trauma at the selected test or control sites.
- Current tobacco smoking or vaping, due to its well-documented detrimental effects on local angiogenesis and soft tissue grafting outcomes.
- Pregnant or lactating females, due to hormonal fluctuations that can temporarily alter the gingival tissue response and capillary permeability.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
Al-mustansiriyah university
Baghdad, Alresafa, 10011
Sajjad Ahmed Shakir, M.Sc., 07730642935 ext. +964, sajjad.shakir1959@gmail.com
About this study
Official title: Gingival Phenotype Modification Using Super-putty C-PRF/Hyaluronic Acid Combination Versus C-PRF Alone in Subjects With Thin Gingival Phenotype: Randomized Clinical Trials
Randomized split mouth clinical trials study focused on comparing the efficacy of C-PRF/ Hyaluronic acid combination versus C-PRF injection alone in subjects with thin gingival phenotype.
Read the detailed description
Gingival phenotype is an important periodontal parameter focused on the gingival thickness and keratinized tissue width.
The gingival phenotype is either thin or thick. Thick gingival phenotype resist infections and periodontal disease more than the thin gingival phenotype.
Multiple surgical approaches to modify the ginigval phenotype from thin to thick has been done in clinical dentistry.
While surgical approach is invasive, recent periodontal trends tends to go with non-invasive ways to treat periodontal conditions. It involves PRF injections as an example.
In this study we're utilizing the PRF combination with Hyaluronic acid and inject this combination to increase the gingival thickness and keratinized tissue width.
- Conditions
- Thin Gingival Phenotype
- Being tested
- C-PRF and Hyaluronic Acid, C-PRF
- Keywords
- periodontics, periodontal phenotype, gingival phenotype, PRF, Hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-PRF and Hyaluronic AcidOther
A mixed preparation consisting of 0.5 mL of Concentrated Platelet-Rich Fibrin (C-PRF) and 0.5 mL of 1.6% cross-linked hyaluronic acid, 0.2% natural Hyaluronic Acid. The mixture is administered via direct subepithelial injection at the mucogingival junction of the target teeth using a 30-gauge needle. 3 injections sessions with 10 days intervals and baseline, 3 months and 6 months follow up visits.
C-PRFOther
1 mL of Concentrated Platelet-Rich Fibrin (C-PRF) is administered via direct subepithelial injection at the mucogingival junction of the target teeth using a 30-gauge needle. 3 injections sessions with 10 days intervals and baseline, 3 months and 6 months follow up visits.
| Study group | Role | What they receive |
|---|---|---|
| C-PRF only | Active comparator | In this group, the participants gingival tissue would be injected with C-PRF only, at a fixed point 1.5mm bellow the free gingival margin. (Using the prefabricated stent, the injection would be repeatable each session). Receives: Other: C-PRF |
| C-PRF/ Hyaluronic acid combination | Experimental | In this group, the participants gingival tissue would be injected with C-PRF/ Hyaluronic acid combination at a fixed point 1.5mm bellow the free gingival margin. (Using the prefabricated stent, the injection would be repeatable each session). Receives: Other: C-PRF and Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gingival Thickness & Keratinized Tissue Width at baseline and at 6 months after the injection of C-PRF/ Hyaluronic acid
Using Trans-ginval probing method to measure the gingival thickness and using Periodontal probe with 1 mm markings to measure the keratinzed tissue width, we measure the difference between the baseline and 6 month after the injection of C-PRF/ Hyaluronic acid and compare the readings with the other side that would be injected with C-PRF alone. (To make the assessments repeatable, we will fabricated a stent for each participant. Each stent has a specific hole to measure the gingival thickness through it in order to make the readings as accurate as possible and all the measurements will be in mm scale).
Measured: baseline - 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin Gingival PhenotypeStudies 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
- 20 participants (estimated)
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 Ahmed Shakir, M.Sc., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682259
- Sponsor's protocol ID
- Sajjad A. Shakir
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 2 Jul 2026
- 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Phenotype Modification Using Super-putty C-PRF/Hyaluronic Acid Combination Versus C-PRF Alone in Subjects With Thin Gingival Phenotype: Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT07682259
- Acronym / sponsor ID
- Sajjad A. Shakir
- Conditions
- Thin Gingival Phenotype
- Keywords
- periodontics, periodontal phenotype, gingival phenotype, PRF, Hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sajjad Ahmed ShakirUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 2 Jul 2026 (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 C-PRF/ Hyaluronic acid combination versus C-PRF injection alone in subjects with thin gingival phenotype.
Detailed description
Gingival phenotype is an important periodontal parameter focused on the gingival thickness and keratinized tissue width.
The gingival phenotype is either thin or thick. Thick gingival phenotype resist infections and periodontal disease more than the thin gingival phenotype.
Multiple surgical approaches to modify the ginigval phenotype from thin to thick has been done in clinical dentistry.
While surgical approach is invasive, recent periodontal trends tends to go with non-invasive ways to treat periodontal conditions. It involves PRF injections as an example.
In this study we're utilizing the PRF combination with Hyaluronic acid and inject this combination to increase the gingival thickness and keratinized tissue width.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-PRF only | Active comparator | Other: C-PRFIn this group, the participants gingival tissue would be injected with C-PRF only, at a fixed point 1.5mm bellow the free gingival margin. (Using the prefabricated stent, the injection would be repeatable each session). |
| C-PRF/ Hyaluronic acid combination | Experimental | Other: C-PRF and Hyaluronic AcidIn this group, the participants gingival tissue would be injected with C-PRF/ Hyaluronic acid combination at a fixed point 1.5mm bellow the free gingival margin. (Using the prefabricated stent, the injection would be repeatable each session). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Systemically healthy male or female adults aged 20 to 40 years.
- Non-smoker.
- Presence of a clinically thin gingival phenotype (gingival thickness ≤ 1.0 mm) at the targeted surgical sites.
- Presence of bilateral homologous teeth (e.g., both maxillary canines, or both mandibular first premolars) exhibiting the same thin gingival phenotype to allow for paired test and control sites within the same oral cavity.
- Patients must demonstrate a high standard of oral hygiene, defined as a full-mouth plaque score and full-mouth bleeding score of ≤ 10% following initial cause-related therapy.
Key exclusion criteria (6 listed)
- Any systemic disease or condition known to compromise wound healing or alter immune response (e.g., uncontrolled diabetes mellitus, autoimmune disorders, bleeding dyscrasias).
- Current or recent use of medications known to induce gingival enlargement (e.g., phenytoin, cyclosporine, calcium channel blockers) or medications affecting blood coagulation and platelet function (e.g., anticoagulants) within last 10 days of the procedure.
- Active periodontitis, defined by probing depths > 3 mm or bleeding on probing at the designated experimental sites
- Any previous history of mucogingival surgery, soft tissue grafting, or local trauma at the selected test or control sites.
- Current tobacco smoking or vaping, due to its well-documented detrimental effects on local angiogenesis and soft tissue grafting outcomes.
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 |
|---|---|---|
| C-PRF and Hyaluronic AcidA mixed preparation consisting of 0.5 mL of Concentrated Platelet-Rich Fibrin (C-PRF) and 0.5 mL of 1.6% cross-linked hyaluronic acid, 0.2% natural Hyaluronic Acid. The mixture is administered via direct subepithelial injection at the mucogingival junction of the target teeth using a 30-gauge needle. 3 injections sessions with 10 days intervals and baseline, 3 months and 6 months follow up visits. | Other | C-PRF/ Hyaluronic acid combination |
| C-PRF1 mL of Concentrated Platelet-Rich Fibrin (C-PRF) is administered via direct subepithelial injection at the mucogingival junction of the target teeth using a 30-gauge needle. 3 injections sessions with 10 days intervals and baseline, 3 months and 6 months follow up visits. | Other | C-PRF only |
Primary outcome
Changes in Gingival Thickness & Keratinized Tissue Width at baseline and at 6 months after the injection of C-PRF/ Hyaluronic acid
Time frame: baseline - 6 months follow up
Using Trans-ginval probing method to measure the gingival thickness and using Periodontal probe with 1 mm markings to measure the keratinzed tissue width, we measure the difference between the baseline and 6 month after the injection of C-PRF/ Hyaluronic acid and compare the readings with the other side that would be injected with C-PRF alone. (To make the assessments repeatable, we will fabricated a stent for each participant. Each stent has a specific hole to measure the gingival thickness through it in order to make the readings as accurate as possible and all the measurements will be in mm scale).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No. the study will be published and shared for other researchers in medical journals.
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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.
Sajjad Ahmed Shakir, M.Sc. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-PRF and Hyaluronic Acid and C-PRF in people with Thin Gingival Phenotype, 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sajjad Ahmed Shakir, M.Sc. (07730642935 ext. +964, sajjad.shakir1959@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Gingival Thickness & Keratinized Tissue Width at baseline and at 6 months after the injection of C-PRF/ Hyaluronic acid (time frame: baseline - 6 months follow up). 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 2 Jul 2026.