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

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

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Device: mechanical debridement; Device: adjunctive aPDT; Device: sham aPDT

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mechanical debridement and adjunctive aPDT	Device: mechanical debridement; subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque; 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.
Active Comparator: mechanical debridement and sham aPDT	Device: mechanical debridement; subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque; Device: sham aPDT; subjects will receive saline and non-light emitting laser on the tooth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of Bleeding Sites (Bleeding On Probing)	Bleeding on probing will be evaluated by gently sweeping the periodontal probe just within the gingival sulcus of the tooth and the presence or absence of bleeding will be recorded .The change is reported as [(number of bleeding sites (bleeding on probing) at the re-evaluation appointment(4 to 6 weeks after baseline) - (number of bleeding sites (bleeding on probing) at baseline)] - a negative value indicated less bleeding sites.	baseline, at the re-evaluation appointment(4 to 6 weeks after baseline)
Change in Number of Bleeding Sites (Bleeding On Probing)	Bleeding on probing will be evaluated by gently sweeping the periodontal probe just within the gingival sulcus of the tooth and the presence or absence of bleeding will be recorded. The change is reported as [(number of bleeding sites (bleeding on probing) at 3 months after baseline) - (number of bleeding sites (bleeding on probing) at baseline)] - a negative value indicated less bleeding sites.	baseline, 3 months after baseline
Change in Probing Depth (Periodontal Pocket Depth )	Periodontal pocket depth is measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. The change is reported as [Periodontal pocket depth at the re-evaluation appointment(4 to 6 weeks after baseline) - (Periodontal pocket depth at baseline)] - a negative value indicates a reduction in pocket depth	baseline, at the re-evaluation appointment (4 to 6 weeks after baseline)
Change in Probing Depth (Periodontal Pocket Depth )	Periodontal pocket depth is measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. The change is reported as [(Periodontal pocket depth at 3 months after baseline) - (Periodontal pocket depth at baseline)] - a negative value indicates a reduction in pocket depth	baseline, 3 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes	Plaque will be sampled, and the subgingival periodontal microbiome will be categorized into different clusters of bacterial species (referred to as Socransky's complexes). We report the percent abundance of 4 different complexes: 1) the Yellow Complex (consisting of S. mutans, S. parasanguinis_clade_411, S. sinensis, and S. vestibularis); the Blue Complex (consisting of Actinomyces gerencseriae, Actinomyces HMT_169, and Actinomyces timonensis); the Orange Complex (consisting of Prevotella fusca, Prevotella histicola, Prevotella jejuni, Prevotella koreensis, Prevotella melaninogenica, Prevotella multiformis, Prevotella nigrescens, Prevotella oris, Prevotella pleuritidis, Prevotella salivae, Prevotella HMT_292, Prevotella HMT_314, Prevotella HMT_443, Prevotella veroralis, Capnocytophaga HMT_412, S. constellatus, and Campylobacter curvus); and the Red Complex (consisting of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Treponema HMT_231, and Treponema HMT_237).	baseline
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes	Plaque will be sampled, and the subgingival periodontal microbiome will be categorized into different clusters of bacterial species (referred to as Socransky's complexes). We report the percent abundance of 4 different complexes: 1) the Yellow Complex (consisting of S. mutans, S. parasanguinis_clade_411, S. sinensis, and S. vestibularis); the Blue Complex (consisting of Actinomyces gerencseriae, Actinomyces HMT_169, and Actinomyces timonensis); the Orange Complex (consisting of Prevotella fusca, Prevotella histicola, Prevotella jejuni, Prevotella koreensis, Prevotella melaninogenica, Prevotella multiformis, Prevotella nigrescens, Prevotella oris, Prevotella pleuritidis, Prevotella salivae, Prevotella HMT_292, Prevotella HMT_314, Prevotella HMT_443, Prevotella veroralis, Capnocytophaga HMT_412, S. constellatus, and Campylobacter curvus); and the Red Complex (consisting of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Treponema HMT_231, and Treponema HMT_237).	at the re-evaluation appointment (4 to 6 weeks after baseline)
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes	Plaque will be sampled, and the subgingival periodontal microbiome will be categorized into different clusters of bacterial species (referred to as Socransky's complexes). We report the percent abundance of 4 different complexes: 1) the Yellow Complex (consisting of S. mutans, S. parasanguinis_clade_411, S. sinensis, and S. vestibularis); the Blue Complex (consisting of Actinomyces gerencseriae, Actinomyces HMT_169, and Actinomyces timonensis); the Orange Complex (consisting of Prevotella fusca, Prevotella histicola, Prevotella jejuni, Prevotella koreensis, Prevotella melaninogenica, Prevotella multiformis, Prevotella nigrescens, Prevotella oris, Prevotella pleuritidis, Prevotella salivae, Prevotella HMT_292, Prevotella HMT_314, Prevotella HMT_443, Prevotella veroralis, Capnocytophaga HMT_412, S. constellatus, and Campylobacter curvus); and the Red Complex (consisting of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Treponema HMT_231, and Treponema HMT_237).	3 months after the debridement (3 months after baseline)
Change in Microbiologic Profile of Gingival Crevicular Fluid(GCF)	GCF will be collected from the sulcus around the target tooth using paper strips (PerioPaper, Oraflow). With proper isolation using cotton rolls in the buccal and lingual aspects of the study site, the area will be dried for 5 seconds with compressed air. The paper strip will be gently introduced into the mucosal crevice around the tooth for 30 seconds per site in four sites.The strips will then be removed from the crevice, and the volume of fluid collected in each strip measured using a micromoisture metering device (Peritron, Oraflow). After confirming the adequateness of the volume, the paper strips from each tooth will be transferred into labeled tubes and stored at -80 C for later use. For analysis, the paper strips will be analyzed using multiplexed fluorescent bead-based immunoassay.	baseline, at the re-evaluation appointment (4 to 6 weeks after baseline), and 3 months after baseline

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Shreena P Bhakta, DDS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: laser therapy; plaque
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Plaque, Amyloid
• Other Study ID Numbers: HSC-DB-21-0998

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No