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

NCT05938868 | Completed

• 1 other identifier: 012/470001072023
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant; Surgical Dental Prostheses; Dental Implantation

Outcome Measures

Primary Outcomes (2)

• Changes in Osseointegration

  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

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

• Changes in soft tissue healing

  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 soft tissue healing immediately postoperative, after 6 weeks and after 3 months

Secondary Outcomes (2)

• 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 Arms (3)

Group A (LIPUS group)

EXPERIMENTAL

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.

Device: Low intensity pulsed ultrasound (LIPUS); Other: Standard Care

Group B (LLLT group)

EXPERIMENTAL

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.

Device: low level diode laser therapy; Other: Standard Care

Group C (Control group)

ACTIVE COMPARATOR

This group will include 17 patients who received Dental Implant Surgery. Patients will be treated with standard care only after surgery for 2 weeks.

Other: Standard Care

Interventions

Low intensity pulsed ultrasound (LIPUS) DEVICE

LIPUS will be delivered intra-orally using a probe applied on the buccal aspect of the implant site. The probe is in contact with the buccal attached gingiva with a thin film of intra oral gel intervening between them, acting as a transmitting medium. It will be applied twice a week for 20 minutes each session that commenced after surgery on the second day and continued for 10 weeks. The intensity of ultrasound therapy used was 30 mW/cm2 with a frequency of 1.5 MHz and temporal average power of 20 Mw

Group A (LIPUS group)

low level diode laser therapy DEVICE

The patients will be irradiated with low level diode laser therapy (GaAs) (Chattanooga, model 27841, USA) .Patient will be irradiated with low level diode laser therapy with parameters: wavelength 850 nm and power of 200 mw in continuous mode will be applied in six points in non-contact method 10 mm away from the peri-implant soft tissue after suturing. The laser irradiations will be administered at six sites that included mesiobuccally, distobuccal, midbuccal, midlingual, mesial, and distal areas around implant for a duration of 10 seconds for each site. The total energy delivered was 6 J per session. And is based on a previous study by Gulati et al., 2020

Group B (LLLT group)

Standard Care OTHER

Patients in all three groups will receive the standard care which includes: (1) Extra-oral ice packs during the first 2 days every two hour; (2) maintain daily routine oral hygiene after surgery; (3) Patients will be instructed to eat a soft diet for one weeks; (4) Broad spectrum oral antibiotics in a dose of one capsule every twelve hours for a week; (5) Non-steroidal anti-inflammatory drugs at a dose of one tablet every 8 hours for four days; (6) Warm chlorhexidine gluconate solution as a mouthwash for a period of 2 weeks to enhance plaque control.

Group A (LIPUS group); Group B (LLLT group); Group C (Control group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahram Canadian University: lead
• Al Hayah University In Cairo: collaborator

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Location

Related Publications (1)

• Mahmoud ES, El-Baky AMA, Gouda OM, Hussein HG. Low intensity pulsed ultrasound versus low-level laser therapy on peri-implant marginal bone preservation and soft tissue healing following dental implant surgery: a randomized controlled trial. Head Face Med. 2025 Apr 23;21(1):29. doi: 10.1186/s13005-025-00502-z.

  PMID: 40269949 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Amal Abd El-Baky, Ph.d

  Cairo University

  STUDY CHAIR

• Osama Gouda, Ph.D

  Faculty of Dentistry, Badr University

  STUDY DIRECTOR

• Hussein Mogahed, Ph.D

  Cairo University

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 11, 2023
• Study Start: July 5, 2023
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)