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Not yet recruitingNCT07682259Updated Jul 2, 2026

Super Putty C-PRF/ Hyaluronic Acid Combination vs C-PRF in Gingival Phenotype Modification in Subjects With Thin Gingival Phenotype

An interventional study of C-PRF and Hyaluronic Acid and C-PRF in Thin Gingival Phenotype, sponsored by Sajjad Ahmed Shakir. Not yet recruiting at 1 site in Iraq. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Sajjad Ahmed Shakir · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Thin Gingival Phenotype

Keywords

  • periodontics
  • periodontal phenotype
  • gingival phenotype
  • PRF
  • Hyaluronic acid
03

In context

Lead sponsor

Sajjad Ahmed Shakir is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Systemically healthy male or female adults aged 20 to 40 years.
  2. Non-smoker.
  3. Presence of a clinically thin gingival phenotype (gingival thickness ≤ 1.0 mm) at the targeted surgical sites.
  4. 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.
  5. 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.
  6. Willingness to comply with the 6-month follow-up schedule and provide written before enrollment.

Exclusion criteria

Exclusion Criteria:

  1. Any systemic disease or condition known to compromise wound healing or alter immune response (e.g., uncontrolled diabetes mellitus, disorders, bleeding dyscrasias).
  2. Current or recent use of medications known to induce gingival enlargement (e.g., phenytoin, cyclosporine, calcium channel blockers) or medications affecting blood coagulation and function (e.g., anticoagulants) within last 10 days of the procedure.
  3. Active periodontitis, defined by probing depths > 3 mm or bleeding on probing at the designated experimental sites
  4. Any previous history of mucogingival surgery, soft tissue grafting, or local trauma at the selected test or control sites.
  5. Current tobacco smoking or vaping, due to its well-documented detrimental effects on local angiogenesis and soft tissue grafting outcomes.
  6. Pregnant or lactating females, due to hormonal fluctuations that can temporarily alter the gingival tissue response and capillary permeability.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    C-PRF only

    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).

    Other: C-PRF

  • Experimental
    C-PRF/ Hyaluronic acid combination

    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).

    Other: C-PRF and Hyaluronic Acid

Interventions

  • OtherC-PRF and Hyaluronic Acid

    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.

  • OtherC-PRF

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: baseline - 6 months follow up

07

Study locations

1 site
  • Al-mustansiriyah university
    Baghdad, Alresafa 10011, Iraq
08

References and documents

Individual participant data

Plan to share: No — the study will be published and shared for other researchers in medical journals.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07682259
Lead sponsor
Sajjad Ahmed Shakir
Responsible party
Sajjad Ahmed Shakir (Master of Science in Periodontics, University of Baghdad) — Sponsor-investigator
First posted
Jul 2, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Jul 2, 2026

Study contacts

Sajjad Ahmed Shakir, M.Sc.
Contact
sajjad.shakir1959@gmail.com
07730642935 ext. +964
Sajjad Ahmed Shakir, M.Sc.
principal investigator

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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