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
Sponsor study identifier
interventional
63
1 country
1
Study Start
July 5, 2023
Actual (reported)Primary Completion
September 12, 2024
Actual (reported)Study Completion
September 12, 2024
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 12, 2024
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2023
Actual (reported)July 5, 2023
Actual (reported)July 11, 2023
Actual (reported)September 12, 2024
Actual (reported)September 12, 2024
Actual (reported)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
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
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.
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.
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
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt
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.
Amal Abd El-Baky, Ph.d
Cairo University
Osama Gouda, Ph.D
Faculty of Dentistry, Badr University
Hussein Mogahed, Ph.D
Cairo University
63 participants (actual enrollment reported by the registry).
First Submitted
July 1, 2023
First Posted
July 11, 2023
Study Start
July 5, 2023
Actual (reported)Assessment of Rapid Osseointegration of Dental Implants with Different Coatings
This group will include 17 patients who received Dental Implant Surgery. Patients will be treated with standard care only after surgery for 2 weeks.
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
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.
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Primary Completion
September 12, 2024
Actual (reported)Study Completion
September 12, 2024
Actual (reported)Last Updated
November 20, 2024
Record last verified: 2024-11
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