NCT05517733

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

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

June 10, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 24, 2022

Last Update Submit

August 24, 2022

Conditions

Immediate Implant Soft Tissue Healing

Outcome Measures

Primary Outcomes (3)

  • 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).

    up to 4 weeks

  • Mid-buccal soft tissue thickness

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

    up to 8 weeks

  • 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.

    up to 8 weeks

Secondary Outcomes (1)

  • Post-operative pain level

    24 hours

Study Arms (2)

Platelet Rich Fibrin (PRF)

EXPERIMENTAL
Biological: Platelet Rich Fibrin

Diode laser

EXPERIMENTAL
Device: Diode laser

Interventions

Platelet Rich FibrinBIOLOGICAL

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
Platelet Rich Fibrin (PRF)
Diode laserDEVICE

* 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.

Diode laser

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of Dental Public Health

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 26, 2022

Study Start

June 10, 2021

Primary Completion

June 20, 2022

Study Completion

June 30, 2022

Last Updated

August 26, 2022

Record last verified: 2022-08

Locations

EG(1)