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

NCT07682259 | Not Yet Recruiting DMC

• 1 other identifier: Sajjad A. Shakir
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thin Gingival Phenotype

Keywords

periodontics; periodontal phenotype; gingival phenotype; PRF; Hyaluronic acid

Outcome Measures

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).

  baseline - 6 months follow up

Study Arms (2)

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).

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).

Other: C-PRF and Hyaluronic Acid

Interventions

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/ Hyaluronic acid combination

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.

C-PRF only

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sajjad Ahmed Shakir: lead

Study Sites (1)

Al-mustansiriyah university

Baghdad, Alresafa, 10011, Iraq

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Sajjad Ahmed Shakir, M.Sc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sajjad Ahmed Shakir, M.Sc.

CONTACT

07730642935; sajjad.shakir1959@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master of Science in Periodontics

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 2, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)