Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT04187053Other idHSC-DB-19-0873

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 56 participants (actual)
Sponsor: The University of Texas Health Science Center, Houston · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 14 Feb 2020
Primary completion: 6 Dec 2022
Completion: 6 Dec 2022
First posted: 5 Dec 2019
Last update posted: 21 Feb 2024
Conditions: DENT IMPLANTS · LASER

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2020202120222023

Ph 4
Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation
NCT04187053
14 Feb 2020 to 6 Dec 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Conventional mechanical therapyProcedure
SalineDrug
Methylene BlueDrug
Light emitting laserDevice
Non-light emitting laserDevice

Arms2

Experimental
Conventional mechanical therapy with aPDT adjunct
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant 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 comparator
Conventional mechanical therapy with sham aPDT treatment
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser

Primary outcomes15

Outcomes the sponsor listed as primary.

Mean Probing Pocket Depth
Time frame · Baseline
Registry description
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.
Mean Probing Pocket Depth
Time frame · 6 weeks post treatment
Registry description
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.
Mean Probing Pocket Depth
Time frame · 12 weeks post treatment
Registry description
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.
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Time frame · Baseline
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Time frame · 6 weeks post treatment
Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss
Time frame · 12 weeks post treatment
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
Time frame · Baseline
Registry description
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.
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
Time frame · 6 weeks post treatment
Registry description
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.
Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing
Time frame · 12 weeks post treatment
Registry description
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.
Number of Sites With Plaque Per Participant
Time frame · Baseline
Registry description
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.
Number of Sites With Plaque Per Participant
Time frame · 6 weeks post treatment
Registry description
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.
Number of Sites With Plaque Per Participant
Time frame · 12 weeks post treatment
Registry description
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.
Max Probing Pocket Depth
Time frame · Baseline
Registry description
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.
Max Probing Pocket Depth
Time frame · 6 weeks post treatment
Registry description
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.
Max Probing Pocket Depth
Time frame · 12 weeks post treatment
Registry description
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.

Secondary outcomes(4)

Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
Time frame · Baseline
Registry description
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.
Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples
Time frame · 12 weeks post treatment
Registry description
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.
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
Time frame · Baseline
Registry description
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.
Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay
Time frame · 12 weeks
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline

Mean Probing Pocket Depth

Group	Value (millimeters)	Spread
Conventional Mechanical Therapy With aPDT Adjunct	4.62	0.49
Conventional Mechanical Therapy With Sham aPDT Treatment	4.45	0.70

Primary outcomeMean· 6 weeks post treatment

Mean Probing Pocket Depth

Group	Value (millimeters)	Spread
Conventional Mechanical Therapy With aPDT Adjunct	3.92	0.63
Conventional Mechanical Therapy With Sham aPDT Treatment	3.54	0.74

Primary outcomeMean· 12 weeks post treatment

Mean Probing Pocket Depth

Group	Value (millimeters)	Spread
Conventional Mechanical Therapy With aPDT Adjunct	4.02	0.66
Conventional Mechanical Therapy With Sham aPDT Treatment	3.63	0.59

Primary outcome· Baseline

Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss

Group	Value
Conventional Mechanical Therapy With aPDT Adjunct	not posted
Conventional Mechanical Therapy With Sham aPDT Treatment	not posted

Primary outcome· 6 weeks post treatment

Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss

Group	Value
Conventional Mechanical Therapy With aPDT Adjunct	not posted
Conventional Mechanical Therapy With Sham aPDT Treatment	not posted

Primary outcome· 12 weeks post treatment

Improvement in Sites as Indicated by Reduction in Inflammation as Assessed by Clinical Attachment Loss

Group	Value
Conventional Mechanical Therapy With aPDT Adjunct	not posted
Conventional Mechanical Therapy With Sham aPDT Treatment	not posted

Primary outcomeMean· Baseline

Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing

Group	Value (Bleeding sites)	Spread
Conventional Mechanical Therapy With aPDT Adjunct	4.42	0.85
Conventional Mechanical Therapy With Sham aPDT Treatment	3.53	0.79

Primary outcomeMean· 6 weeks post treatment

Number of Bleeding Sites Per Participant as Assessed by Bleeding on Probing

Group	Value (Bleeding sites)	Spread
Conventional Mechanical Therapy With aPDT Adjunct	3.11	1.21
Conventional Mechanical Therapy With Sham aPDT Treatment	2.13	1.29

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Conventional Mechanical Therapy With aPDT AdjunctTraditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant 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. Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy Methylene Blue: Experimental arm will receive methylene blue Light emitting laser: Experimental arm will receive Light emitting laser	0 / 30	0 / 30	0 / 30
Conventional Mechanical Therapy With Sham aPDT TreatmentControl group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser Conventional mechanical therapy: Both experimental and sham arms will receive the Conventional mechanical therapy Saline: Sham group will receive saline as a sham for methylene blue Non-light emitting laser: Sham group will receive Non-light emitting laser	0 / 26	0 / 26	0 / 26

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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