NCT07736833

Brief Summary

The present study was designed to investigate the clinical efficacy of liquid-phase concentrated growth factors (LPCGF) as an adjunct to ethylenediaminetetraacetic acid (EDTA) for root surface biomodification prior to free gingival grafting for the management of Cairo type 1 gingival recession defects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 26, 2026

Last Update Submit

July 26, 2026

Conditions

Keywords

FGG with EDTA and LPCGF root biomodification

Outcome Measures

Primary Outcomes (2)

  • Width of attached gingiva (AG)

    calculated by subtracting probing pocket depth from the width of keratinized gingiva measured from the free gingival margin to the mucogingival junction, as determined by the roll technique

    Baseline, 1 month, 3 months, and 6 months

  • Gingival thickness (GT)

    baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (5)

  • Probing pocket depth (PPD)

    baseline and 6 months postoperative

  • Recession width (RW)

    Baseline, 1 month, 3 months, and 6 months.

  • Recession depth (RD)

    baseline, 1 month, 3 months, and 6 months

  • Clinical attachment level (CAL)

    base line and 6 months postoperative

  • Percentage of root coverage (RC)

    6 months postoperative

Study Arms (2)

Group I: Free gingival graft (FGG) with EDTA root surface biomodification

ACTIVE COMPARATOR

Group I: Free gingival graft (FGG) with EDTA root surface biomodification

Procedure: Free gingival graft (FGG) with EDTA root surface biomodification

Group II: Free gingival graft (FGG) with EDTA and LPCGF root surface

EXPERIMENTAL

Group II: Free gingival graft (FGG) with EDTA and LPCGF root surface

Procedure: Free gingival graft (FGG) with EDTA and LPCGF root surface application

Interventions

Free gingival graft (FGG) with EDTA and LPCGF root surface biomodification

Group II: Free gingival graft (FGG) with EDTA and LPCGF root surface

Free gingival graft (FGG) with EDTA root surface biomodification

Group I: Free gingival graft (FGG) with EDTA root surface biomodification

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18 to 50 years old.
  • Patients with good systemic health with no contraindication for periodontal surgery.
  • No history of systemic or local medications within the previous six months that could affect periodontal tissue health or wound healing.
  • Recession depth ≥ 3 mm, measured from the cementoenamel junction (CEJ) to the gingival margin and/ or width of attached gingiva \< 3 mm.
  • Presence of identifiable cementoenamel junction (CEJ).
  • Absence of interproximal attachment loss (i.e., intact interdental bone and soft tissue, confirmed radiographically).
  • Ability to maintain adequate oral hygiene, as demonstrated during recall visits.

You may not qualify if:

  • Restoration or caries in the site to be treated or non-vital tooth.
  • Previous mucogingival surgery at the defect.
  • Active infectious diseases (hepatitis, HIV, etc.).
  • Smokers and pregnant patients.
  • Teeth that are tilted rotated or have any non-alterable occlusal abnormalities.
  • Sites with tooth mobility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, Tanta university

Tanta, Gharbia Governorate, 31773, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

fibrinopeptides gamma

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The 20 sites will be classified randomly by the sealed envelope technique into the two treatment groups, 10 sites in each group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

July 26, 2026

First Posted

July 30, 2026

Study Start

February 21, 2024

Primary Completion

February 21, 2025

Study Completion

May 20, 2025

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations