Clinical trial NCT04187053: Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation
Official title: Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical Treatment of Peri-implant Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: DENT IMPLANTS
LASER
Keywords: Dental implants
Laser
Antimicrobial photodynamic therapy
Low level laser therapy
Peri-implant mucositis
Peri-implantitis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Academy of Laser Dentistry
First posted: 2019-12-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare clinical outcomes (change in bleeding sites (BOP) and probing depth reduction (PPD) after mechanical debridement of implant surfaces at sites exhibiting plaque induced inflammation with or without adjunctive antimicrobial photodynamic therapy (aPDT) and assess the microbiologic profile of plaque samples before and after treatment with or without aPDT samples.


Eligibility criteria: Inclusion Criteria:

* at least one implant with peri-implant inflammation that requires non-surgical treatment.
* Peri-implant diseases included are peri-implant mucositis and peri-implantitis

Criteria for diagnosis of peri-implant mucositis or peri-implantitis:

1. Red, swollen gingival tissues surrounding the implant
2. Presence of bleeding and/or suppuration on gentle probing around the implant
3. Increased probing depth compared to probing depth after restoration of the implant (greater than 2mm increase in probing depth)
4. May or may not have progressive bone loss in relation to radiographic bone levels assessed either 1 year following restoration of the implant OR ≥3mm of radiographic bone loss from the implant platform -systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.

Exclusion Criteria:

* current heavy smokers (\>10 cigarettes/day)
* have diabetes or other systemic diseases that may comprise healing
* take antibiotics within 3 months before the procedure

Primary outcomes:
measure: Mean Probing Pocket Depth
timeFrame: Baseline
measure: Mean Probing Pocket Depth
timeFrame: 6 weeks post treatment
measure: Mean Probing Pocket Depth
timeFrame: 12 weeks post treatment
measure: Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
timeFrame: Baseline
measure: Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
timeFrame: 6 weeks post treatment
measure: Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
timeFrame: 12 weeks post treatment
measure: Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
timeFrame: Baseline
measure: Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
timeFrame: 6 weeks post treatment
measure: Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
timeFrame: 12 weeks post treatment
measure: Number of Sites With Plaque Per Participant
timeFrame: Baseline
measure: Number of Sites With Plaque Per Participant
timeFrame: 6 weeks post treatment
measure: Number of Sites With Plaque Per Participant
timeFrame: 12 weeks post treatment
measure: Max Probing Pocket Depth
timeFrame: Baseline
measure: Max Probing Pocket Depth
timeFrame: 6 weeks post treatment
measure: Max Probing Pocket Depth
timeFrame: 12 weeks post treatment
Secondary outcomes:
measure: Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
timeFrame: Baseline
measure: Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
timeFrame: 12 weeks post treatment
measure: Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
timeFrame: Baseline
measure: Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston School of Dentistry
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jiayin Tan, DDS
role: PRINCIPAL_INVESTIGATOR
References: