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NCT Number: NCT06535035

Evaluation of the Analgesic and Anti-Inflammatory Impact of Photobiomodulation in Patients With Dental Implants

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.

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Key information

Conditions

Dental Pain and Sensation Disorder Facial Pain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pia Lopez Jornet

Murcia, 30008, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who needed dental implant rehabilitation and signed the informed consent

Exclusion criteria

  • Participants with a poor general health status, decompensated chronic diseases, pregnant women, and those with bleeding disorders were excluded.

Treatment and study plan

laser therapy After implant surgery, laser therapy (LLLT) was applied

Device

After implant surgery, laser therapy (LLLT) was applied a single session with an EPIC X Biolase diode laser (BIOLASE, Inc., USA)

Other names: Experimental

SHAM

Device

After implant surgery, After implant surgery, laser therapy (LLLT) was applied in the same manner but without activating it

Other names: After implant surgery, laser therapy (LLLT) was applied without activating it

Primary outcomes

  1. Pain levels assessed with the visual analogue scale (VAS)

    Time frame: 24h-48h,7 days

    A score of 0 indicated no pain while 10 indicated the worst pain possible

  2. inflammation evels assessed with the visual analogue scale

    Time frame: 24h-48h,7 days

    A score of 0 indicated no inflammation while 10 indicated the worst inflammation possible

Secondary outcomes

  1. Modified Corah Dental Anxiety Scale (MDAS)

    Time frame: 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).

  2. OHIP-14sp

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Acronym: AAPDI

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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