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

NCT06535035 | Completed

• 1 other identifier: 2934/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Pain and Sensation Disorder

Keywords

laser; pain, dental implant , quality of life , MDA

Outcome Measures

Primary Outcomes (2)

• Pain levels assessed with the visual analogue scale (VAS)

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

  24h-48h,7 days

• inflammation evels assessed with the visual analogue scale

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

  24h-48h,7 days

Secondary Outcomes (2)

• Modified Corah Dental Anxiety Scale (MDAS)

  at day 0 and 7 days

• OHIP-14sp

  at 0 and at 7 days

Study Arms (2)

Group1 laser therapy

EXPERIMENTAL

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

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

group Sham

SHAM COMPARATOR

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

Device: SHAM

Interventions

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)

Also known as: Experimental

Group1 laser therapy

SHAM DEVICE

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

Also known as: After implant surgery, laser therapy (LLLT) was applied without activating it

group Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Pia Lopez Jornet

Murcia, 30008, Spain

Location

Related Publications (2)

• Qu C, Luo F, Hong G, Wan Q. Effects of photobiomodulation therapy on implant stability and postoperative recovery: a systematic review and meta-analysis. Br J Oral Maxillofac Surg. 2022 Jun;60(5):e712-e721. doi: 10.1016/j.bjoms.2022.01.014. Epub 2022 Feb 5.

  PMID: 35490059 BACKGROUND

• Heidari M, Paknejad M, Jamali R, Nokhbatolfoghahaei H, Fekrazad R, Moslemi N. Effect of laser photobiomodulation on wound healing and postoperative pain following free gingival graft: A split-mouth triple-blind randomized controlled clinical trial. J Photochem Photobiol B. 2017 Jul;172:109-114. doi: 10.1016/j.jphotobiol.2017.05.022. Epub 2017 May 18.

  PMID: 28549319 BACKGROUND

MeSH Terms

Conditions

Toothache; Sensation Disorders; Pain

Interventions

Laser Therapy; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: During the initial evaluation, data collection, informed consent, a complete clinical and oral evaluation, as well as a radiological study with cone beam computed tomography (CBCT) were carried out. Subsequently, surgical intervention was performed with the placement of dental implants. In the experimental group, low-level laser therapy (LLLT) was applied, while a placebo procedure (SHAM) was used in the control group. 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Oral Medicine

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 2, 2024
• Study Start: January 10, 2022
• Primary Completion: January 10, 2024
• Study Completion: June 10, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

ES (1)