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

NCT ID: NCT06535035

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2024-06-10

Brief Summary

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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

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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

Conditions

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Dental Pain and Sensation Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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

Study Groups

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Group1 laser therapy

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 Type EXPERIMENTAL

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

Intervention Type DEVICE

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

group 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

Group Type SHAM_COMPARATOR

SHAM

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

SHAM

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

Intervention Type DEVICE

Other Intervention Names

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Experimental After implant surgery, laser therapy (LLLT) was applied without activating it

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Pia Lopez Jornet

Professor Oral Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pia Lopez Jornet

Murcia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 35490059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28549319 (View on PubMed)

Other Identifiers

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2934/2020

Identifier Type: -

Identifier Source: org_study_id

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