Trial Outcomes & Findings for Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical and Surgical Treatment of Teeth With Periodontal Disease (NCT NCT05252000)

NCT ID: NCT05252000

Last Updated: 2026-03-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

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

Results posted on

2026-03-12

Participant Flow

20 participants were enrolled. Each participant served as their own control. For each participant 2 teeth were treated - 1 tooth was treated with Adjunctive aPDT and 1 tooth was treated with sham aPDT.

Unit of analysis: teeth

Participant milestones

Participant milestones
Measure	Mechanical Debridement and Adjunctive aPDT mechanical 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.	Mechanical Debridement and Sham aPDT mechanical 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 tooth
Overall Study STARTED	20 20	20 20
Overall Study COMPLETED	20 20	20 20
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Mechanical Debridement and Sham aPDT n=20 teeth mechanical 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 tooth	Mechanical Debridement and Adjunctive aPDT n=20 teeth mechanical 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.
Change in Number of Bleeding Sites (Bleeding On Probing)	-1.60 bleeding sites Standard Deviation 1.26	-1.40 bleeding sites Standard Deviation 1.71

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mechanical Debridement and Sham aPDT n=20 teeth mechanical 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 tooth	Mechanical Debridement and Adjunctive aPDT n=20 teeth mechanical 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.
Change in Number of Bleeding Sites (Bleeding On Probing)	-1.40 bleeding sites Standard Deviation 1.58	-1.80 bleeding sites Standard Deviation 1.40

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Mechanical Debridement and Sham aPDT n=20 teeth mechanical 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 tooth	Mechanical Debridement and Adjunctive aPDT n=20 teeth mechanical 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.
Change in Probing Depth (Periodontal Pocket Depth )	-0.18 millimeters Standard Deviation 0.50	-0.53 millimeters Standard Deviation 0.39

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Mechanical Debridement and Sham aPDT n=20 teeth mechanical 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 tooth	Mechanical Debridement and Adjunctive aPDT n=20 teeth mechanical 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.
Change in Probing Depth (Periodontal Pocket Depth )	-0.03 millimeters Standard Deviation 0.54	-0.60 millimeters Standard Deviation 0.45

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Mechanical Debridement and Sham aPDT n=20 teeth mechanical 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 tooth	Mechanical Debridement and Adjunctive aPDT n=20 teeth mechanical 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.
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes Yellow Complex	1.54 percentage of total bacterial abundance Standard Deviation 0.05	1.80 percentage of total bacterial abundance Standard Deviation 0.05
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes Blue Complex	11.22 percentage of total bacterial abundance Standard Deviation 0.15	11.42 percentage of total bacterial abundance Standard Deviation 0.15
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes Orange Complex	2.30 percentage of total bacterial abundance Standard Deviation 0.06	1.96 percentage of total bacterial abundance Standard Deviation 0.05
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes Red Complex	1.38 percentage of total bacterial abundance Standard Deviation 0.04	1.91 percentage of total bacterial abundance Standard Deviation 0.04

SECONDARY outcome

Timeframe: at the re-evaluation appointment (4 to 6 weeks after baseline)

Outcome measures

Outcome measures
Measure	Mechanical Debridement and Sham aPDT n=20 Teeth mechanical 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 tooth	Mechanical Debridement and Adjunctive aPDT n=20 Teeth mechanical 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.
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes Yellow Complex	2.06 percentage of total abundance Standard Deviation 0.06	3.41 percentage of total abundance Standard Deviation 0.08
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes Blue Complex	16.25 percentage of total abundance Standard Deviation 0.18	15.36 percentage of total abundance Standard Deviation 0.15
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes Orange Complex	2.02 percentage of total abundance Standard Deviation 0.05	1.38 percentage of total abundance Standard Deviation 0.03
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes Red Complex	0.33 percentage of total abundance Standard Deviation 0.01	0.08 percentage of total abundance Standard Deviation 0.002

SECONDARY outcome

Timeframe: 3 months after the debridement (3 months after baseline)

Outcome measures

Outcome measures
Measure	Mechanical Debridement and Sham aPDT n=20 teeth mechanical 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 tooth	Mechanical Debridement and Adjunctive aPDT n=20 teeth mechanical 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.
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes Yellow Complex	2.52 percentage of total abundance Standard Deviation 0.06	2.98 percentage of total abundance Standard Deviation 0.06
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes Blue Complex	13.62 percentage of total abundance Standard Deviation 0.16	12.00 percentage of total abundance Standard Deviation 0.17
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes Orange Complex	1.81 percentage of total abundance Standard Deviation 0.04	2.21 percentage of total abundance Standard Deviation 0.05
Microbiologic Profile of Plaque as Indicated by Percent of Total Abundance of 4 Oral Bacterial Complexes Red Complex	2.35 percentage of total abundance Standard Deviation 0.05	1.13 percentage of total abundance Standard Deviation 0.03

SECONDARY outcome

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

Population: Data were not collected for this outcome measure because gingival crevicular fluid(GCF) were not collected therefore data is not available for any participant. The study protocol was not amended to reflect this collective team decision. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure.

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.

Outcome measures

Outcome data not reported

Adverse Events

Mechanical Debridement and Adjunctive aPDT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mechanical Debridement and Sham aPDT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Chang, DDS

The University of Texas Health Science Center at Houston

Phone: +1 (713) 486-4287

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Mechanical Debridement and Sham aPDT n=20 Teeth mechanical 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 tooth	Mechanical Debridement and Adjunctive aPDT n=20 Teeth mechanical 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.	Total n=40 Teeth Total of all reporting groups
Age, Continuous	61.90 years STANDARD_DEVIATION 5.78 • n=20 Participants	61.90 years STANDARD_DEVIATION 5.78 • n=20 Participants	61.90 years STANDARD_DEVIATION 5.78 • n=20 Participants
Sex/Gender, Customized Female	16 participants n=20 Participants	16 participants n=20 Participants	16 participants n=20 Participants
Sex/Gender, Customized Male	4 participants n=20 Participants	4 participants n=20 Participants	4 participants n=20 Participants
Race/Ethnicity, Customized Caucasian	4 participants n=20 Participants	4 participants n=20 Participants	4 participants n=20 Participants
Race/Ethnicity, Customized African American	4 participants n=20 Participants	4 participants n=20 Participants	4 participants n=20 Participants
Race/Ethnicity, Customized Hispanic	11 participants n=20 Participants	11 participants n=20 Participants	11 participants n=20 Participants
Race/Ethnicity, Customized Middle Eastern	1 participants n=20 Participants	1 participants n=20 Participants	1 participants n=20 Participants
Region of Enrollment United States	20 participants n=20 Participants	20 participants n=20 Participants	20 participants n=20 Participants
Number of Participants with Hypertension	8 participants n=20 Participants	8 participants n=20 Participants	8 participants n=20 Participants
Number of Participants with Diabetes	1 participants n=20 Participants	1 participants n=20 Participants	1 participants n=20 Participants
Number of Participants with Osteoporosis	1 participants n=20 Participants	1 participants n=20 Participants	1 participants n=20 Participants
Probing Depth (Periodontal Pocket Depth )	2.97 millimeters STANDARD_DEVIATION 0.61 • n=20 Teeth	3.35 millimeters STANDARD_DEVIATION 0.43 • n=20 Teeth	3.16 millimeters STANDARD_DEVIATION 0.52 • n=40 Teeth
Number of Bleeding Sites (Bleeding On Probing)	3.60 bleeding sites STANDARD_DEVIATION 1.27 • n=20 Teeth	3.75 bleeding sites STANDARD_DEVIATION 1.45 • n=20 Teeth	3.675 bleeding sites STANDARD_DEVIATION 1.36 • n=40 Teeth
Initial Periodontal Diagnosis Localized Stage II Grade B	5 participants n=20 Participants	5 participants n=20 Participants	5 participants n=20 Participants
Initial Periodontal Diagnosis Localized Stage III Grade B	5 participants n=20 Participants	5 participants n=20 Participants	5 participants n=20 Participants
Initial Periodontal Diagnosis Generalized Stage III Grade B	10 participants n=20 Participants	10 participants n=20 Participants	10 participants n=20 Participants