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

NCT ID: NCT05938868

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-05
• Study Completion Date: 2024-09-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A (LIPUS group)

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 Type: EXPERIMENTAL

Low intensity pulsed ultrasound (LIPUS)

Intervention Type: 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

Standard Care

Intervention Type: 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 B (LLLT group)

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 Type: EXPERIMENTAL

low level diode laser therapy

Intervention Type: 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

Standard Care

Intervention Type: 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 C (Control group)

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 Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: 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.

Interventions

Low intensity pulsed ultrasound (LIPUS)

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

Intervention Type: DEVICE

low level diode laser therapy

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

Intervention Type: DEVICE

Standard Care

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al Hayah University In Cairo

OTHER

Sponsor Role: collaborator

Ahram Canadian University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Abd El-Baky, Ph.d

Role: STUDY_CHAIR

Cairo University

Osama Gouda, Ph.D

Role: STUDY_DIRECTOR

Faculty of Dentistry, Badr University

Hussein Mogahed, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 40269949 (View on PubMed)

Other Identifiers

012/470001072023

Identifier Type: -

Identifier Source: org_study_id