CClinicalTrials.gg
CompletedNCT05517733Updated Aug 26, 2022

ASSESSMENT OF SOFT TISSUE HEALING OVER IMMEDIATELY PLACED IMPLANT SEALED WITH PLATELETS RICH FIBRIN (PRF) VERSUS DIODE LASER

An interventional study of Platelet Rich Fibrin and Diode laser in Immediate Implant Soft Tissue Healing, sponsored by Nourhan M.Aly. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-08-26.

Sponsored by Nourhan M.Aly · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jun 2021, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Aim of the current study was to assess the efficacy of PRF in comparison to diode laser to promote tissue healing and soft tissue quality after placement of immediate implants.

02

Conditions studied

  • Immediate Implant Soft Tissue Healing
03

In context

Lead sponsor

Nourhan M.Aly is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Any non-restorable hopeless tooth: a badly decayed tooth that cannot be restored, tooth with failed endodontic treatment, and teeth with longitudinal fracture.
  • Post-extraction sockets type 1 with all bony walls intact; Type I extraction sockets according to Elian classification in 2007 have an intact labial plate of the bone and no soft tissue recession. Therefore, it does not require a mucoperiosteal flap elevation, only bone graft particles are packed into the socket after atraumatic extraction and socket debridement, then sealed with barrier membranes or soft tissue grafts.
  • No signs of active periodontal disease in the selected tooth.
  • Good oral hygiene

Exclusion criteria

Exclusion Criteria:

  • The presence of any systemic disease could complicate bone or soft tissue healing after immediate implant placement.
  • The presence of Acute periapical infection.
  • The presence of any local factor that may interfere with extraction as tooth ankyloses
  • Subjects who had undergone therapeutical radiation. (187)
  • Patients who had been subjected to or who were under bisphosphonate therapy
05

Study design

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

Study arms

  • Experimental
    Platelet Rich Fibrin (PRF)

    Biological: Platelet Rich Fibrin

  • Experimental
    Diode laser

    Device: Diode laser

Interventions

  • BiologicalPlatelet Rich Fibrin

    for the preparation of PRF, A well-trained professional nurse drew 10ml of patient blood from the antecubital vein and transferred it to a test tube without anticoagulant. The blood sample was immediately centrifuged for 10-12 minutes at 3000 rpm. L-PRF was ready to use after centrifugation. PRF membrane was put over the implant and slightly tucked under the soft tissue periphery, then held in place with a figure-of-8 suture by 0.5 proline suture

    Also known as: PRF

  • DeviceDiode laser

    * A 980 nm diode laser device (BIOLASE) was applied in a circular motion to the blood formed at the socket orifice at a power of 1W for 1 minute with a continuous wave mode, the application was done without touching the pooling blood and with a non-activated tip of the fiber optic. * The laser application cycle was repeated 3-5 times to yield a stable fixed blood clot covering the dental implant with no oozing blood from its periphery.

06

What researchers measure

Primary outcomes

  1. Soft tissue healing

    This was done using Landry healing index. It evaluates the parameters of tissue colour, bleeding response to palpation, presence of granulation tissue, characteristics of the incision margins, and the presence of suppuration. The score ranges from 1 (Very poor) to 5 (Excellent).

    Time frame: up to 4 weeks

  2. Mid-buccal soft tissue thickness

    Measured from the gingival margin to implant platform using a periodontal probe.

    Time frame: up to 8 weeks

  3. Mid-crestal soft tissue height

    Measured using a periodontal probe passing through soft tissue in the intersection midpoint of both buccolingual and mesiodistal dimensions of the socket till cover screw.

    Time frame: up to 8 weeks

Secondary outcomes

  1. Post-operative pain level

    This was measured using the Visual Analogue Scale (VAS) that rates pain level on a scale of 0-10 (with 0 meaning no pain at all and 100 meaning the worst possible pain). A VAS questionnaire was given to the subjects and they were asked to select their pain score.

    Time frame: 24 hours

07

Study locations

1 site
  • Faculty of Dentistry, Alexandria University
    Alexandria, 21512, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05517733
Lead sponsor
Nourhan M.Aly
Responsible party
Nourhan M.Aly (Assistant Lecturer of Dental Public Health, University of Alexandria) — Sponsor-investigator
First posted
Aug 26, 2022
Start date
Jun 10, 2021
Primary completion
Jun 20, 2022
Completion
Jun 30, 2022
Last update
Aug 26, 2022

Oversight

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

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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