What side effects are associated with this type of intervention?

Common treatments for gum disease include mechanical debridement, antibiotics, and adjunctive therapies such as antimicrobial photodynamic therapy (aPDT). Mechanical debridement can cause temporary discomfort and gum sensitivity. Antibiotics may lead to gastrointestinal disturbances and antibiotic resistance. aPDT, which uses light-activated compounds to kill bacteria, can cause mild side effects such as temporary gum irritation, sensitivity, and, in rare cases, allergic reactions. Overall, aPDT is generally well-tolerated with minimal adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for gum disease, though specific approvals for antimicrobial photodynamic therapy (aPDT) are not well-documented. Traditional treatments include mechanical debridement, antibiotics, and antiseptic mouthwashes. aPDT, which involves the use of light-activated compounds to kill bacteria, is an emerging therapy being studied for its potential benefits in treating periodontal disease. This method aims to enhance the effects of conventional treatments by targeting and reducing bacterial populations more effectively.

What other types of research exist?

Promising novel alternatives to aPDT for gum disease patients include: 1) Local Drug Delivery Systems (e.g., chlorhexidine, doxycycline) which provide targeted antimicrobial effects. 2) Systemic antibiotics (e.g., amoxicillin-plus-metronidazole) as adjuncts to scaling and root planing. 3) Host-modulation therapies using non-antibacterial tetracycline formulations to reduce inflammation. 4) Low-level laser therapy (LLLT) which has shown potential in improving healing and symptoms. 5) Autologous platelet concentrates (APC) to enhance healing in conjunction with surgical procedures.

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Procedure

aPDT + Mechanical Debridement for Gum Disease

N/A

Waitlist Available

Led By Shreena P Bhakta, DDS

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No furcation involvement

Be older than 18 years old

Must not have

Current heavy smokers (>10 cigarettes/day)

Vertical bone defects that requires surgical regenerative treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a method to clean inflamed gums caused by plaque, with or without an additional light-based treatment that kills bacteria. It aims to see if the light treatment improves outcomes for patients with gum inflammation. Blue light-emitting toothbrushes have shown effectiveness in reducing dental plaques and gum inflammation through both mechanical removal and light action.

Who is the study for?

This trial is for individuals with gum disease who have at least one tooth on each side of their mouth with a pocket depth greater than 4mm and bleeding upon probing. They must not be heavy smokers, pregnant, or have uncontrolled diabetes or other systemic diseases that affect healing.

What is being tested?

The study is examining the effectiveness of Antimicrobial photodynamic therapy (aPDT) as an addition to mechanical debridement in treating teeth affected by periodontal disease. It will also assess changes in the microbiologic profile of these sites before and after treatment.

What are the potential side effects?

While specific side effects are not listed, aPDT generally has minimal side effects which may include slight discomfort during treatment and temporary sensitivity or irritation in the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My gums do not have any areas where the roots of my teeth split.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I smoke more than 10 cigarettes a day.

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I need surgery to fix bone loss in my jaw.

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My diabetes is not under control (HbA1c is 6.5% or higher).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in number of bleeding sites (Bleeding On Probing)

Change in probing depth (Periodontal pocket depth )

Secondary study objectives

change in microbiologic profile of gingival crevicular fluid(GCF)

change in microbiologic profile of plaque

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: mechanical debridement and adjunctive aPDTExperimental Treatment2 Interventions

Group II: mechanical debridement and sham aPDTActive Control2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mechanical debridement

2021

N/A

~70

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antimicrobial photodynamic therapy (aPDT) is a treatment for gum disease that involves the use of light-activated compounds to kill bacteria. This therapy works by applying a photosensitizing agent to the affected area, which is then activated by a specific wavelength of light. The activation produces reactive oxygen species that destroy bacterial cells, reducing inflammation and infection. This method is particularly beneficial for gum disease patients as it targets bacteria directly and can be used adjunctively with mechanical debridement to enhance clinical outcomes. Other common treatments for gum disease include mechanical debridement (scaling and root planing), which physically removes plaque and tartar, and the use of antimicrobial mouth rinses or antibiotics to reduce bacterial load. The importance of these treatments lies in their ability to manage bacterial infection, reduce inflammation, and prevent the progression of periodontal disease, ultimately preserving oral health and preventing tooth loss.