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A Topical Desiccant Agent in Association With Manual Debridement in the Treatment of Peri-implant Mucositis

NCT03858959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-03-01

No results posted yet for this study

Summary

In patients presenting peri-implant mucositis, effective sub-mucosal debridement is crucial to prevent peri-implantitis. The aim of this pilot study was to assess the 3-month clinical and microbiological effects of a locally delivered liquid desiccant agent with molecular hygroscopic properties, in association with sub-gingival manual debridement, in sites with peri-implant mucositis.

Twenty-three patients presenting at least one implant with no radiographically detectable bone loss, a pocket probing depth ≥ 4 mm and bleeding on probing, were included in a 3-month randomized, parallel-groups, single-blind, prospective study. At baseline (T0), patients were randomly assigned to receive a desiccant liquid agent with molecular hygroscopic properties before debridement (Test-Group), or a Chlorhexidine 1% disinfectant gel after debridement (Control-Group). Treatments were performed also after 7 and 14 days. Peri- implant soft tissues assessment (PPD, BOP, mBI, VPI, mPLI) and microbial sampling were assessed at baseline and at 3-month follow-up (T1).

Conditions

  • Peri-implant Mucositis

Interventions

DEVICE

topical agent

HBX protocol consisted in product application into the periodontal pocket (starting from the base) with a delivery syringe, second saline solution irrigation after 60 seconds to flush-out the product and Teflon-curettes debridement to remove the deposits. CHX protocol consisted in Teflon-curettes debridement to remove the deposits, associated with a first saline solution irrigation, and product application into the periodontal pocket (starting from the base) with a delivery syringe.

Sponsors & Collaborators

  • Universita di Verona

    lead OTHER

Principal Investigators

  • Giorgio Lombardo · Università di Verona

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
37 Years
Max Age
71 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2018-10-25
Completion
2018-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03858959 on ClinicalTrials.gov