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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05252000
• Other study ID #: HSC-DB-21-0998
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: October 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Shreena P Bhakta, DDS
• Phone: 713-499-9072
• Email: Shreena.P.Bhakta[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Device:
• 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.
• sham aPDT
subjects will receive saline and non-light emitting laser on the tooth

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery
Primary	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	baseline, at the re-evaluation appointment (4 to 6 weeks after baseline), and 3 months after the osseous surgery
Secondary	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.	baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery
Secondary	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.	baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery