CClinicalTrials.gg
Status unknownNCT03219944Updated Jul 19, 2017

Clinical Evaluation of Platelet Rich Fibrin Versus Subepithelial Connective Tissue Graft for Soft Tissue Augmentation

An interventional study of Platelet Rich Fibrin and sub epithelial connective tissue graft in Patients With at Least Single Missing Anterior Tooth and Thin Gingival Biotype, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-19.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

Soft tissue biotype is a critical factor for success of implant in the esthetic zone . Different soft tissue augmentation techniques have been employed to increase soft tissue thickness such as: autogenous grafts, allografts, xenografts and living cellular construct (LCC). Studies showed that, allografts and xenografts were inferior when compared with autogenous graft . However, few studies were conducted to evaluate the efficacy of soft tissue augmentation with platelet rich fibrin in order to overcome the patient morbidity with SCTG.

02

Conditions studied

  • Patients With at Least Single Missing Anterior Tooth
  • Thin Gingival Biotype
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patients with missing maxillary anterior toot teeth.
  2. Thin gingival biotype.
  3. Adequate inter-arch space for placement of the implant prosthetic part.
  4. Good oral hygiene where gingival index is (0, 1) (Loe and Silness 1963).

Exclusion criteria

Exclusion Criteria:

  1. Patient with medical condition that is contraindicated with the surgical procedure
  2. Patients receiving treatment that affect the healing ability.
  3. Patients with local pathological defects related to the area of interest.
  4. Smokers or pregnant women.
  5. Patients with parafunctional habits that may jeopardize the implant longevity and affect the results of the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Platelet Rich Fibrin for soft tissue augmentation

    blood will be drawn from the patient vein for PRF. The blood sample will be centrifuged for 10-12 min. PRF membrane is obtained

    Procedure: Platelet Rich Fibrin

  • Active comparator
    sub epithelial connective tissue graft

    The connective tissue graft will be harvested from the palate. Then the SCTG will be placed over the recipient site extending palataly and sutured.

    Procedure: sub epithelial connective tissue graft

Interventions

  • ProcedurePlatelet Rich Fibrin

    : Platelet Rich Fibrin for soft tissue augmentation around implant in the aesthetic zone

  • Proceduresub epithelial connective tissue graft

    sub epithelial connective tissue graft for soft tissue augmentation around implant in the aesthetic zone

06

What researchers measure

Primary outcomes

  1. Crestal bone resorption

    measured mesially and distally using periapical xray in mm

    Time frame: 6 months

07

Study locations

1 site
  • Maymohamedkamal
    Cairo, Elmaniel 11311, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03219944
Lead sponsor
Cairo University
Responsible party
may mohamed kamal (master student, Cairo University) — Principal investigator
First posted
Jul 18, 2017
Start date
Aug 15, 2017 (estimated)
Primary completion
Jan 1, 2018 (estimated)
Completion
Jan 1, 2018 (estimated)
Last update
Jul 19, 2017

Study contacts

may mo kamal
Contact
maykamalmo@gmail.com
01063392983

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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