Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation

LASER Clinical Trial

Official title:

Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical Treatment of Peri-implant Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187053
• Other study ID #: HSC-DB-19-0873
• Status: Completed
• Phase: Phase 4
• Start date: February 14, 2020
• Est. completion date: December 6, 2022

Study information

• Verified date: January 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• DENT IMPLANTS
• LASER

Intervention

Procedure:
• Conventional mechanical therapy
Both experimental and sham arms will receive the Conventional mechanical therapy

Drug:
• Saline
Sham group will receive saline as a sham for methylene blue
• Methylene Blue
Experimental arm will receive methylene blue

Device:
• Light emitting laser
Experimental arm will receive Light emitting laser
• Non-light emitting laser
Sham group will receive Non-light emitting laser

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Academy of Laser Dentistry (ALD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Probing Pocket Depth	Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.	Baseline
Primary	Mean Probing Pocket Depth	Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.	6 weeks post treatment
Primary	Mean Probing Pocket Depth	Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, an average of the depths of the 6 sites is reported.	12 weeks post treatment
Primary	Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss		Baseline
Primary	Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss		6 weeks post treatment
Primary	Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss		12 weeks post treatment
Primary	Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing	Bleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.	Baseline
Primary	Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing	Bleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.	6 weeks post treatment
Primary	Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing	Bleeding on probing (BOP) will be assessed, where each of 6 gingival areas (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be gently swept by the periodontal probe just within the gingival sulcus of the implant and the presence or absence of bleeding will be recorded.	12 weeks post treatment
Primary	Number of Sites With Plaque Per Participant	Presence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.	Baseline
Primary	Number of Sites With Plaque Per Participant	Presence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.	6 weeks post treatment
Primary	Number of Sites With Plaque Per Participant	Presence of plaque was evaluated at six sites (mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual) around the implant surface and the presence of plaque will be recorded.	12 weeks post treatment
Primary	Max Probing Pocket Depth	Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.	Baseline
Primary	Max Probing Pocket Depth	Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.	6 weeks post treatment
Primary	Max Probing Pocket Depth	Periodontal pocket depth was measured from the free gingival margin to the base of the pocket, with a UNC periodontal probe with 1mm measurement units. It was assessed at 6 sites per implant: mesiobuccal, mid-buccal, distobuccal, distolingual, mid-lingual, and mesiolingual. For each participant, the depth of the deepest of the 6 sites is reported.	12 weeks post treatment
Secondary	Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples	Plaque samples will be taken from the deepest probing site of each implant at baseline and 12 weeks after aPDT. To assess bacteria in the sample, the V4 region of the 16S rRNA gene will be PCR amplified and sequenced, and 16S rRNA gene data will then be analyzed to determine the alpha diversity of the microbiota community at the implant site. In this study, the minimum alpha diversity is 1 and the maximum is 2501. A higher alpha diversity indicates a higher number of bacterial or taxonomic "units" in the sample.	Baseline
Secondary	Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples	Plaque samples will be taken from the deepest probing site of each implant at baseline and 12 weeks after aPDT. To assess bacteria in the sample, the V4 region of the 16S rRNA gene will be PCR amplified and sequenced, and 16S rRNA gene data will then be analyzed to determine the alpha diversity of the microbiota community at the implant site. In this study, the minimum alpha diversity is 1 and the maximum is 2501. A higher alpha diversity indicates a higher number of bacterial or taxonomic "units" in the sample.	12 weeks post treatment
Secondary	Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay	PISF samples will be taken from six sites of each implant at baseline and 12 weeks after aPDT. The levels of interleukin IL-1a, IL-1b, IL-6, IL-8, IL-10, IL-12, IL-7A, tumor necrosis factor (TNF)-a, C-reactive protein, osteoprotegerin, leptin, and adiponectin will be determined using multiplex proteomic immunoassays.	Baseline
Secondary	Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay	PISF samples will be taken from six sites of each implant at baseline and 12 weeks after aPDT. The levels of interleukin IL-1a, IL-1b, IL-6, IL-8, IL-10, IL-12, IL-7A, tumor necrosis factor (TNF)-a, C-reactive protein, osteoprotegerin, leptin, and adiponectin will be determined using multiplex proteomic immunoassays.	12 weeks