Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical and Surgical Treatment of Teeth With Periodontal Disease

NCT ID: NCT05252000

Last Updated: 2022-11-03

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-26

Study Completion Date

2024-07-01

Brief Summary

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The purpose of this study is to compare clinical outcomes after mechanical debridement of at sites exhibiting plaque induced inflammation with or without adjunctive Antimicrobial photodynamic therapy (aPDT) and to assess the the microbiologic profile before and after treatment with or without aPDT

Detailed Description

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Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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mechanical debridement and adjunctive aPDT

Group Type EXPERIMENTAL

mechanical debridement

Intervention Type DEVICE

subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque

adjunctive aPDT

Intervention Type DEVICE

Antimicrobial photodynamic therapy will be done at tooth sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. After 3 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the tooth using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.

mechanical debridement and sham aPDT

Group Type ACTIVE_COMPARATOR

mechanical debridement

Intervention Type DEVICE

subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque

sham aPDT

Intervention Type DEVICE

subjects will receive saline and non-light emitting laser on the tooth

Interventions

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mechanical debridement

subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque

Intervention Type DEVICE

adjunctive aPDT

Antimicrobial photodynamic therapy will be done at tooth sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. After 3 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the tooth using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.

Intervention Type DEVICE

sham aPDT

subjects will receive saline and non-light emitting laser on the tooth

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* One pocket on each side of the mouth (split design)
* Single rooted tooth
* Pocket depths measured greater than 4mm with bleeding on probing
* Horizontal bone loss
* No furcation involvement

Exclusion Criteria

* current heavy smokers (\>10 cigarettes/day)
* have uncontrolled diabetes (HbA1c ≥ 6.5%)
* other uncontrolled systemic diseases that may comprise healing, such as Vitamin C deficiency, any neutrophil deficiencies, immunodeficiency syndromes, or leukemia
* taking antibiotics within 3 months before the procedure
* vertical bone defects that requires surgical regenerative treatment.
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Shreena Pranav Bhakta

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shreena P Bhakta, DDS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shreena P Bhakta, DDS

Role: CONTACT

713-499-9072

Jennifer Chang

Role: CONTACT

(713) 486-4049

Facility Contacts

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Shreena P Bhakta, DDS

Role: primary

713-499-9072

Jennifer Chang

Role: backup

(713) 486-4049

Other Identifiers

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HSC-DB-21-0998

Identifier Type: -

Identifier Source: org_study_id

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