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Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

NCTNCT05252000 (opens ClinicalTrials.gov in a new tab)Other idHSC-DB-21-0998
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Methylene blue, does not test it. It appears in the description.

Overview

Status
Completed
Phase
Not applicable
Enrollment
20 participants (actual)
Sponsor
The University of Texas Health Science Center, Houston · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
26 Apr 2022
Primary completion
10 Oct 2023
Completion
10 Oct 2023
First posted
23 Feb 2022
Last update posted
12 Mar 2026
Conditions
Periodontal Diseases

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. N/A

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

    NCT05252000

    26 Apr 2022 to 10 Oct 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • mechanical debridementDevice
  • adjunctive aPDTDevice
  • sham aPDTDevice

Arms2

  • Experimental

    mechanical debridement and adjunctive aPDT

  • Active comparator

    mechanical debridement and sham aPDT

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Change in Number of Bleeding Sites (Bleeding On Probing)

    Time frame · baseline, at the re-evaluation appointment(4 to 6 weeks after baseline)

    Registry description

    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.

  2. Change in Number of Bleeding Sites (Bleeding On Probing)

    Time frame · baseline, 3 months after baseline

    Registry description

    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.

  3. Change in Probing Depth (Periodontal Pocket Depth )

    Time frame · baseline, at the re-evaluation appointment (4 to 6 weeks after baseline)

    Registry description

    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

  4. Change in Probing Depth (Periodontal Pocket Depth )

    Time frame · baseline, 3 months after baseline

    Registry description

    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

Secondary outcomes(4)

  1. Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes

    Time frame · baseline

    Registry description

    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).

  2. Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes

    Time frame · at the re-evaluation appointment (4 to 6 weeks after baseline)

    Registry description

    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. Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes

    Time frame · 3 months after the debridement (3 months after baseline)

    Registry description

    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).

  4. Change in Microbiologic Profile of Gingival Crevicular Fluid(GCF)

    Time frame · baseline, at the re-evaluation appointment (4 to 6 weeks after baseline), and 3 months after baseline

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· baseline, at the re-evaluation appointment(4 to 6 weeks after baseline)

Change in Number of Bleeding Sites (Bleeding On Probing)

GroupValue (bleeding sites)Spread
Mechanical Debridement and Sham aPDT-1.601.26
Mechanical Debridement and Adjunctive aPDT-1.401.71
Primary outcomeMean· baseline, 3 months after baseline

Change in Number of Bleeding Sites (Bleeding On Probing)

GroupValue (bleeding sites)Spread
Mechanical Debridement and Sham aPDT-1.401.58
Mechanical Debridement and Adjunctive aPDT-1.801.40
Primary outcomeMean· baseline, at the re-evaluation appointment (4 to 6 weeks after baseline)

Change in Probing Depth (Periodontal Pocket Depth )

GroupValue (millimeters)Spread
Mechanical Debridement and Sham aPDT-0.180.50
Mechanical Debridement and Adjunctive aPDT-0.530.39
Primary outcomeMean· baseline, 3 months after baseline

Change in Probing Depth (Periodontal Pocket Depth )

GroupValue (millimeters)Spread
Mechanical Debridement and Sham aPDT-0.030.54
Mechanical Debridement and Adjunctive aPDT-0.600.45
Secondary and other outcome results(4)
Secondary outcomeMean· baseline

Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes

GroupValue (percentage of total bacterial abundance)Spread
Mechanical Debridement and Sham aPDT1.540.05
Mechanical Debridement and Adjunctive aPDT1.800.05
Secondary outcomeMean· 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

GroupValue (percentage of total abundance)Spread
Mechanical Debridement and Sham aPDT2.060.06
Mechanical Debridement and Adjunctive aPDT3.410.08
Secondary outcomeMean· 3 months after the debridement (3 months after baseline)

Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes

GroupValue (percentage of total abundance)Spread
Mechanical Debridement and Sham aPDT2.520.06
Mechanical Debridement and Adjunctive aPDT2.980.06
Secondary outcome· baseline, at the re-evaluation appointment (4 to 6 weeks after baseline), and 3 months after baseline

Change in Microbiologic Profile of Gingival Crevicular Fluid(GCF)

GroupValue
Mechanical Debridement and Adjunctive aPDTnot posted
Mechanical Debridement and Sham aPDTnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Mechanical Debridement and Adjunctive aPDTmechanical debridement: subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque 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.0 / 200 / 200 / 20
Mechanical Debridement and Sham aPDTmechanical debridement: subjects will receive traditional non-surgical mechanical debridement of tooth surfaces with scalers and ultrasonics removing supragingival and subgingival plaque sham aPDT: subjects will receive saline and non-light emitting laser on the tooth0 / 200 / 200 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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