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NCT Number: NCT07682259

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-mustansiriyah university

Baghdad, Alresafa, 10011, Iraq

Location contact

Sajjad Ahmed Shakir, M.Sc.

CONTACT

[email protected]

07730642935 ext. +964

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

C-PRF and Hyaluronic Acid

Other

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-PRF

Other

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.

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sajjad Ahmed Shakir, M.Sc.

CONTACT

[email protected]

07730642935 ext. +964

Sponsors and collaborators

Lead sponsor

Sajjad Ahmed Shakir

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.