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Dental ImplantNCT05938868

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

A study testing Low intensity pulsed ultrasound (LIPUS) and low level diode laser therapy in people with Dental Implant and Surgical Dental Prostheses, run by Ahram Canadian University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Low intensity pulsed ultrasound (LIPUS) and low level diode laser therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteEgypt
Study dates
5 Jul 2023to 12 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Outpatient clinic of faculty of physical therapy, Ahram Canadian University

    Al Ḩayy Ath Thāmin, Giza Governorate, 3221405

Other trials in Egypt

About this study

Official title: 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

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.

Being tested
Low intensity pulsed ultrasound (LIPUS), low level diode laser therapy, Standard Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • low level diode laser therapyDevice

    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

  • Standard CareOther

    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.

Study groups in NCT05938868
Study groupRoleWhat they receive
Group A (LIPUS group)ExperimentalThis group will include 17 patients who received Dental Implant Surgery. Patients will be treated with low intensity pulsed ultrasound in addition to standard care.
Receives: Device: Low intensity pulsed ultrasound (LIPUS); Other: Standard Care
Group B (LLLT group)ExperimentalThis 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.
Receives: Device: low level diode laser therapy; Other: Standard Care
Group C (Control group)Active comparatorThis group will include 17 patients who received Dental Implant Surgery. Patients will be treated with standard care only after surgery for 2 weeks.
Receives: Other: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

Secondary outcomes (2)

  1. Changes in Pain pressure threshold

    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

    Measured: Changes in Pain pressure threshold immediately postoperative, after 6 weeks and after 3 months

  2. Changes in oral quality of life

    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.

    Measured: Changes in oral quality of life immediately postoperative, after 6 weeks and after 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2023
  2. Study start5 Jul 2023
  3. Primary completion12 Sep 2024
  4. Study completion12 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05938868
Sponsor's protocol ID
012/470001072023
Status last verified
Nov 2024
First submitted
1 Jul 2023
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40269949

Questions about this trial

What is this clinical trial studying?

A study testing Low intensity pulsed ultrasound (LIPUS) and low level diode laser therapy in people with Dental Implant and Surgical Dental Prostheses, run by Ahram Canadian University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Osseointegration (time frame: Changes in Osseintegration immediately postoperative, after 6 weeks and after 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05938868, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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