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

Primary Purpose

Periodontal Diseases

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

mechanical debridement

adjunctive aPDT

sham aPDT

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring plaque, laser therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mechanical debridement and adjunctive aPDT

mechanical debridement and sham aPDT

Arm Description

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

change in microbiologic profile of plaque

Plaque sampling will be performed using a curette within the gingival sulcus of the inflamed site. The sample sites will first be isolated by cotton rolls and supragingival and marginal plaque will be removed before subgingival biofilm samples collected using sterile scalers. The collected samples will be immediately placed in separate sterile Eppendorf tubes containing 0.15 ml TE .Samples will be stored at -80 °C until further analysis.

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.

Full Information

NCT ID

NCT05252000

First Posted

February 11, 2022

Last Updated

October 31, 2022

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT05252000

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 26, 2022 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Diseases

Keywords

plaque, laser therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mechanical debridement and adjunctive aPDT

Arm Type

Experimental

Arm Title

mechanical debridement and sham aPDT

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

mechanical debridement

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

adjunctive aPDT

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

sham aPDT

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in number of bleeding sites (Bleeding On Probing)

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.

Time Frame

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

Title

Change in probing depth (Periodontal pocket depth )

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

Time Frame

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

Secondary Outcome Measure Information:

Title

change in microbiologic profile of plaque

Description

Time Frame

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

Title

change in microbiologic profile of gingival crevicular fluid(GCF)

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shreena P Bhakta, DDS

Phone

713-499-9072

Shreena.P.Bhakta@uth.tmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Chang

Phone

(713) 486-4049

Jennifer.Chang@uth.tmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shreena P Bhakta, DDS

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shreena P Bhakta, DDS

Phone

713-499-9072

Shreena.P.Bhakta@uth.tmc.edu

First Name & Middle Initial & Last Name & Degree

Jennifer Chang

Phone

(713) 486-4049

Jennifer.Chang@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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