Skip to main content
OpenTrials
Completed

NCT Number: NCT05252000

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontal Diseases Mouth Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mechanical debridement

Device

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

adjunctive aPDT

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.

sham aPDT

Device

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

Primary outcomes

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

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

    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

    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)

    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

    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

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

    Time frame: baseline

    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)

    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)

    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

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2022
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.