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

Not Applicable

Recruiting

• Conditions: Periodontal Diseases
• Interventions: Device: mechanical debridement; Device: sham aPDT; Device: adjunctive aPDT

• Registration Number: NCT05252000
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-02-23
• Study Start: 2022-04-26
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-03
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mechanical debridement and sham aPDT	sham aPDT	-
mechanical debridement and adjunctive aPDT	mechanical debridement	-
mechanical debridement and adjunctive aPDT	adjunctive aPDT	-
mechanical debridement and sham aPDT	mechanical debridement	-

Primary Outcome Measures

Name	Time	Method
Change in number of bleeding sites (Bleeding On Probing)	baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery	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 )	baseline, at the re-evaluation appointment (4 to 6 weeks after baseline), and 3 months after the osseous surgery	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

Name	Time	Method
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 the osseous surgery	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.
change in microbiologic profile of plaque	baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States