Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535035
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Evaluation of the Analgesic and Anti-Inflammatory Impact of Photobiomodulation in Patients With Dental Implants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Analgesic and Anti-Inflammatory Impact of Photobiomodulation in Patients With Dental Implants
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AAPDI
Brief Summary:
The aim of this study is to evaluate the analgesic and anti-inflammatory effects of photobiomodulation in participants undergoing dental implant placement
A randomized clinical trial was conducted with 62 participants requiring dental implant placement divided into two groups of 31 each Immediately after implant placement one group received diode laser photobiomodulation while the SHAM group received sham treatment Pain and inflammation were assessed at 24 h 48 h and 7 days In addition Modified Dental Anxiety MDA levels were measured and the Oral Health Impact Profile-14 OHIP-14 questionnaire was used to assess oral health-related quality of life
A randomized clinical trial was conducted with 62 participants requiring dental implant placement divided into two groups of 31 each Immediately after implant placement one group received diode laser photobiomodulation while the SHAM group received sham treatment Pain and inflammation were assessed at 24 h 48 h and 7 days In addition Modified Dental Anxiety MDA levels were measured and the Oral Health Impact Profile-14 OHIP-14 questionnaire was used to assess oral health-related quality of life
Detailed Description:
Low-Level Laser Therapy LLLT has revolutionized medicine promoting the healing and regeneration of tissues in an innovative way This study focuses on evaluating the powerful analgesic and anti-inflammatory effects of LLLT in patients undergoing dental implant placement
Methodology A randomized clinical trial was conducted with 62 patients divided into two groups of 31 each One group received photobiomodulation with a combined 630 and 808 nm diode laser while the SHAM group received a simulated treatment
Inclusion criteria Participants who needed dental implant rehabilitation and signed the informed consent Participants with a poor general health status decompensated chronic diseases diabetes pregnant women and those with bleeding disorders were excluded
Procedure
Informed consent data collection complete clinical and oral evaluation and radiological study with CBCT
Surgical intervention
Placement of dental implants In the experimental group low-level laser therapy LLLT was applied immediately after the placement of the implants in a single session with an EPIC X Biolase diode laser BIOLASE Inc USA voltage 100-240 V 15 A power 05 W 10-20 J for 10-30 seconds It was applied to three points in the area buccal side palatallingual side and occlusal side to stimulate the tissue
Pain and inflammation were evaluated using visual analog scales VAS from day 0 to 7 days postoperatively Additionally MDA levels were measured and the OHIP-14 questionnaire was used to assess oral health-related quality of life
Methodology A randomized clinical trial was conducted with 62 patients divided into two groups of 31 each One group received photobiomodulation with a combined 630 and 808 nm diode laser while the SHAM group received a simulated treatment
Inclusion criteria Participants who needed dental implant rehabilitation and signed the informed consent Participants with a poor general health status decompensated chronic diseases diabetes pregnant women and those with bleeding disorders were excluded
Procedure
Informed consent data collection complete clinical and oral evaluation and radiological study with CBCT
Surgical intervention
Placement of dental implants In the experimental group low-level laser therapy LLLT was applied immediately after the placement of the implants in a single session with an EPIC X Biolase diode laser BIOLASE Inc USA voltage 100-240 V 15 A power 05 W 10-20 J for 10-30 seconds It was applied to three points in the area buccal side palatallingual side and occlusal side to stimulate the tissue
Pain and inflammation were evaluated using visual analog scales VAS from day 0 to 7 days postoperatively Additionally MDA levels were measured and the OHIP-14 questionnaire was used to assess oral health-related quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None