Evaluation of the Analgesic and Anti-Inflammatory Impact of Photobiomodulation in Patients With Dental Implants
- Conditions
- Dental Pain and Sensation Disorder
- Interventions
- Device: laser therapy After implant surgery, laser therapy (LLLT) was appliedDevice: SHAM
- Registration Number
- NCT06535035
- Lead Sponsor
- Universidad de Murcia
- 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.
- 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, 1.5 A, power 0.5 W, 10-20 J, for 10-30 seconds. It was applied to three points in the area: buccal side, palatal/lingual 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Participants who needed dental implant rehabilitation and signed the informed consent
- Participants with a poor general health status, decompensated chronic diseases, pregnant women, and those with bleeding disorders were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group1 laser therapy laser therapy After implant surgery, laser therapy (LLLT) was applied Data collection, informed consent, a complete clinical and oral evaluation, as well as a radiological study with cone beam computed tomography (CBCT). A surgical intervention was performed with the 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, 1.5 A, power 0.5 W, 10-20 J, for 10-30 seconds. It was applied to three points in the area: buccal side, palatal/lingual 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 group Sham SHAM data collection, informed consent, a complete clinical and oral evaluation, as well as a radiological study with cone beam computed tomography (CBCT). Surgical intervention was performed with the placement of dental implants. In the group sham comparate p, low-level laser therapy (LLLT) was applied inactive . 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
- Primary Outcome Measures
Name Time Method inflammation evels assessed with the visual analogue scale 24h-48h,7 days A score of 0 indicated no inflammation while 10 indicated the worst inflammation possible
Pain levels assessed with the visual analogue scale (VAS) 24h-48h,7 days A score of 0 indicated no pain while 10 indicated the worst pain possible
- Secondary Outcome Measures
Name Time Method OHIP-14sp at 0 and at 7 days consists of 14 questions related to different dimensions of the patient's quality of life (functional limitation, pain, psychological problems, etc.) higher score worse quality of life
Modified Corah Dental Anxiety Scale (MDAS) at day 0 and 7 days (0 relaxed, 1 slightly anxious, 2 quite anxious, 3 very anxious or 4 extremely anxious). The total sum was obtained and 4 ranges of fear and anxiety were established (\<9 mild or no anxiety, 9-12 moderate anxiety, 13-14 high anxiety, \>14 phobic anxiety, \>14 very anxious anxiety, \>14 very anxious anxiety, \>14 very anxious anxiety, \>14 very anxious anxiety, \>14 very anxious anxiety).
Trial Locations
- Locations (1)
Pia Lopez Jornet
🇪🇸Murcia, Spain