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

NCT04187053 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: HSC-DB-19-0873
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

DENT IMPLANTS; LASER

Keywords

Dental implants; Laser; Antimicrobial photodynamic therapy; Low level laser therapy; Peri-implant mucositis; Peri-implantitis

Outcome Measures

Primary Outcomes (15)

• 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

• 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

• 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

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

  Baseline

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

  6 weeks post treatment

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

  12 weeks post treatment

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples

  Baseline

• Alpha Diversity as Indicated by Analysis of 16S rRNA Gene Data From Plaque Samples

  12 weeks post treatment

• Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay

  Baseline

• Levels of Immunologic Biomarkers in Peri-implant Sulcular Fluid (PISF) Sample as Assessed by Multiplexed Fluorescent Bead-based Immunoassay

  12 weeks

Study Arms (2)

Conventional mechanical therapy with aPDT adjunct

EXPERIMENTAL

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.

Procedure: Conventional mechanical therapy; Drug: Methylene Blue; Device: Light emitting laser

Conventional mechanical therapy with sham aPDT treatment

SHAM COMPARATOR

Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser

Procedure: Conventional mechanical therapy; Drug: Saline; Device: Non-light emitting laser

Interventions

Conventional mechanical therapy PROCEDURE

Both experimental and sham arms will receive the Conventional mechanical therapy

Conventional mechanical therapy with aPDT adjunct; Conventional mechanical therapy with sham aPDT treatment

Saline DRUG

Sham group will receive saline as a sham for methylene blue

Conventional mechanical therapy with sham aPDT treatment

Methylene Blue DRUG

Experimental arm will receive methylene blue

Conventional mechanical therapy with aPDT adjunct

Light emitting laser DEVICE

Experimental arm will receive Light emitting laser

Conventional mechanical therapy with aPDT adjunct

Non-light emitting laser DEVICE

Sham group will receive Non-light emitting laser

Conventional mechanical therapy with sham aPDT treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Red, swollen gingival tissues surrounding the implant
• Presence of bleeding and/or suppuration on gentle probing around the implant
• Increased probing depth compared to probing depth after restoration of the implant (greater than 2mm increase in probing depth)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Academy of Laser Dentistry: collaborator

Study Sites (1)

University of Texas Health Science Center at Houston School of Dentistry

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Sodium Chloride; Methylene Blue

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Srinivas Ayilavarapu, BDS, DSc, MDS
• Organization: University of Texas Health Science Center at Houston

srinivas.ayilavarapu@uth.tmc.edu

713-486-4390

Study Officials

• Jiayin Tan, DDS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontics Resident

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 5, 2019
• Study Start: February 14, 2020
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: February 21, 2024
• Results First Posted: December 29, 2023

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)