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

NCT05252000 | Completed Results FDA Device

• 1 other identifier: HSC-DB-21-0998
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontal Diseases

Keywords

plaque; laser therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

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

  baseline

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

  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

  3 months after the debridement (3 months after baseline)

• Change in Microbiologic Profile of Gingival Crevicular Fluid(GCF)

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

Study Arms (2)

mechanical debridement and adjunctive aPDT

EXPERIMENTAL

Device: mechanical debridement; Device: adjunctive aPDT

mechanical debridement and sham aPDT

ACTIVE COMPARATOR

Device: mechanical debridement; Device: sham aPDT

Interventions

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.

mechanical debridement and adjunctive aPDT

mechanical debridement DEVICE

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

mechanical debridement and adjunctive aPDT; mechanical debridement and sham aPDT

sham aPDT DEVICE

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

mechanical debridement and sham aPDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Periodontal Diseases; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jennifer Chang, DDS
• Organization: The University of Texas Health Science Center at Houston

jennifer.chang@uth.tmc.edu

+1 (713) 486-4287

Study Officials

• Shreena P Bhakta, DDS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 23, 2022
• Study Start: April 26, 2022
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: March 12, 2026
• Results First Posted: March 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)