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

The University of Texas System (UT)

Status: Enrolling

Conditions: Periodontal Diseases

Treatments: Device: adjunctive aPDT; Device: sham aPDT; Device: mechanical debridement

Study type: Interventional

Funder types: Other

Identifiers

NCT05252000

HSC-DB-21-0998

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

mechanical debridement and adjunctive aPDT

Experimental group

Treatment:

Device: adjunctive aPDT

Device: mechanical debridement

mechanical debridement and sham aPDT

Active Comparator group

Treatment:

Device: sham aPDT

Device: mechanical debridement