NCT05911607

Brief Summary

Goal of this study is to compare between the effect of two different low power lasers on extraction socket healing.

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 Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

June 2, 2023

Last Update Submit

June 20, 2023

Conditions

Extraction Socket Healing

Outcome Measures

Primary Outcomes (1)

  • Radiographic socket dimensions

    Alveolar Socket surface area measured on Cone Beam Computerised Tomography

    3 months

Secondary Outcomes (2)

  • Soft tissue healing

    15 days

  • Histological examination

    3 months

Study Arms (2)

Red Laser

ACTIVE COMPARATOR

Photobiomodulation using nm Diode.

Procedure: Low power laser

Infrared Laser

ACTIVE COMPARATOR

Photobiomodulation using nm Diode.

Procedure: Low power laser

Interventions

Low power laserPROCEDURE

Phototherapy for extraction sockets using two different lasers.

Infrared LaserRed Laser

Eligibility Criteria

Age30 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Fit for implant rehabilitation.
  • Acceptable oral hygiene.
  • Willingness to attend 6 visits within 15 days of extraction.

You may not qualify if:

  • Uncontrolled diabetes.
  • Sub optimal oral hygiene.
  • Heavy smoker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institut of laser enhanced sciences

Cairo, 12613, Egypt

Location

Related Publications (1)

  • Rosero KAV, Sampaio RMF, Deboni MCZ, Correa L, Marques MM, Ferraz EP, da Graca Naclerio-Homem M. Photobiomodulation as an adjunctive therapy for alveolar socket preservation: a preliminary study in humans. Lasers Med Sci. 2020 Oct;35(8):1711-1720. doi: 10.1007/s10103-020-02962-y. Epub 2020 Jan 22.

    PMID: 31970564BACKGROUND

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Ahmed Ab Zaky

    National Institute of Laser Enhanced Sciences, Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Histological examination
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Comparing between 2 laser' effect on extraction socket healing
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, PhD candidate, researcher in National Institute of Laser Enhanced Sciences.

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 22, 2023

Study Start

July 1, 2021

Primary Completion

August 1, 2022

Study Completion

September 15, 2022

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)