Low Intensity Pulsed Ultrasound Versus Low Level Laser Therapy Post Dental Implant

Not Applicable

Completed

• Conditions: Surgical Dental Prostheses; Dental Implant; Dental Implantation
• Interventions: Device: low level diode laser therapy; Device: Low intensity pulsed ultrasound (LIPUS); Other: Standard Care

• Registration Number: NCT05938868
• Lead Sponsor: Ahram Canadian University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-01
• Study First Submitted QC: 2023-07-01
• Study Start: 2023-07-05
• Study First Posted: 2023-07-11
• Primary Completion: 2024-09-12
• Study Completion: 2024-09-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-17
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (LLLT group)	low level diode laser therapy	This group will include 17 patients who received Dental Implant Surgery. The patients will be irradiated with low level diode laser therapy (GaAs) in addition to standard care.
Group B (LLLT group)	Standard Care	This group will include 17 patients who received Dental Implant Surgery. The patients will be irradiated with low level diode laser therapy (GaAs) in addition to standard care.
Group C (Control group)	Standard Care	This group will include 17 patients who received Dental Implant Surgery. Patients will be treated with standard care only after surgery for 2 weeks.
Group A (LIPUS group)	Low intensity pulsed ultrasound (LIPUS)	This group will include 17 patients who received Dental Implant Surgery. Patients will be treated with low intensity pulsed ultrasound in addition to standard care.
Group A (LIPUS group)	Standard Care	This group will include 17 patients who received Dental Implant Surgery. Patients will be treated with low intensity pulsed ultrasound in addition to standard care.

Primary Outcome Measures

Name	Time	Method
Changes in soft tissue healing	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	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 Outcome Measures

Name	Time	Method
Changes in Pain pressure threshold	Changes in Pain pressure threshold immediately postoperative, after 6 weeks and after 3 months	Pain pressure threshold at temporalis and masseter muscles will be measured at immediately post dental implant, after 6 weeks and after 3 months of treatment. A blinded assessor will use an algometer (FPX 25, Wagner Instruments, Greenwich CT, USA), a device that measures pressure or applied force on any part of the body, to register the pressure pain threshold (PPT) for temporalis and masseter muscles
Changes in oral quality of life	Changes in oral quality of life immediately postoperative, after 6 weeks and after 3 months	Oral health-related quality of life is an established and relevant instrument with which to describe patient satisfaction. It will be measured at immediately post dental implant, after 6 weeks and after 3 months of treatment. OHRQoL consisting of 12-Item short-form Oral Health-Related Quality of Life Measures with a scale from 0 to 4 (Never, hardly ever, Occasionally, Fairly Often and Very Often) with higher scores indicating greater satisfaction.

Trial Locations

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt