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Clinical Trials/NCT05938868
NCT05938868
Completed
Not Applicable

Efficacy of Low Intensity Pulsed Ultrasound and Low Level Laser Therapy on Osseointegration and Soft Tissue Healing Following Dental Implant Surgery: a Randomized Controlled Trial

Ahram Canadian University1 site in 1 country63 target enrollmentJuly 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant
Sponsor
Ahram Canadian University
Enrollment
63
Locations
1
Primary Endpoint
Changes in soft tissue healing
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of the study is to investigate the significance difference between low intensity pulsed ultrasound (LIPUS) versus low-level laser therapy (LLLT) on osseointegration, soft tissue healing, pain pressure threshold and oral health related quality of life in patients post dental implant surgery.

Registry
clinicaltrials.gov
Start Date
July 5, 2023
End Date
September 12, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Ahram Canadian University

Eligibility Criteria

Inclusion Criteria

  • Adult Patients.
  • Both sexes will be contributed in the study.
  • Non-smokers.
  • Patients who needed dental implant in the maxillary or in the mandible.
  • Bone height and width no less than Class III bone quality assessed clinically and radiologically.

Exclusion Criteria

  • Medically compromised patients as Uncontrolled diabetes mellitus.
  • Patients indicated for bone graft at the implant site.
  • Patients under chemotherapy or radiotherapy in facial region.
  • Poor oral hygiene.
  • Patients with any history of temporomandibular joint disorders.
  • Patients with any other periodontal and oral surgeries

Outcomes

Primary Outcomes

Changes in soft tissue healing

Time Frame: Changes in soft tissue healing immediately postoperative, after 6 weeks and after 3 months

Landry index for soft tissue healing will be used to measure soft tissue healing. The healing index (HI) evaluates healing based on redness, presence of granulation tissues, bleeding, suppuration, and epithelialization. A score of 1-5 was given with score 1 for very poor healing and 5 being excellent healing of the tissues. Higher scores indicate better healing rates. This index assesses the surgical wound by clinical examination.

Changes in Osseointegration

Time Frame: Changes in Osseintegration immediately postoperative, after 6 weeks and after 3 months

X-ray Radiograph will be performed for each patients and then analyzied by Specialized software to evaluate the osseointegration between bone and implant surface. The radiographs will be taken in high-resolution mode (Vista Scan Durr Dental, Durr Dental Italy S.r.l) with a dental X-ray machine (TM 2002 Planmeca Proline CC, Planmeca Group Helsinki, Finland) equipped with a long tube that operated at 70 Kw/7.5 mA. Specialized software (DBSWIN software, Durr Dental Italy S.r.l) will be used for linear measurements of marginal bone changes

Secondary Outcomes

  • Changes in Pain pressure threshold(Changes in Pain pressure threshold immediately postoperative, after 6 weeks and after 3 months)
  • Changes in oral quality of life(Changes in oral quality of life immediately postoperative, after 6 weeks and after 3 months)

Study Sites (1)

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